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Accredited Technical Training for the Pharmaceutical, Cosmetic, Food and Medical Device Industries Course Catalog July – September 2008 U.S. Course Offerings Course T opics in this Catalog Include : Excipient GMPs Globally Harmonized Systems (GHS) ICH Q10: Pharmaceutical Quality System ISO 13485, ISO 9001 and QSR Regulations for Medical Device Companies Process Analytical Technology (PAT) REACH: Registration, Evaluation and Authorization of Chemicals Siloxane Technology & Personal Care Applications CfP A Courses Offer: Topics from Introductory to Advanced Access to Leading Industry Experts An Informative and Interactive Learning Environment Practical Knowledge You Can Use to Improve Job Performance Application Oriented Real Life Case Studies Accreditation and Certification www.cfpa.com Limited Seats Available. Register Today! NEW NEW

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Page 1: Accredited Technical Training for the … July-Sept PH catalog.pdfAccredited Technical Training for the Pharmaceutical, Cosmetic, Food and Medical Device Industries Course Catalog

Accredited Technical Training for the Pharmaceutical, Cosmetic, Food and Medical Device IndustriesCourse Catalog

July – September 2008U.S. Course Offerings

Course Topics in this Catalog Include: • Excipient GMPs

• Globally Harmonized Systems (GHS)

• ICH Q10: Pharmaceutical Quality System

• ISO 13485, ISO 9001 and QSR Regulations for Medical Device Companies

• Process Analytical Technology (PAT)

• REACH: Registration, Evaluation and Authorization of Chemicals

• Siloxane Technology & Personal Care Applications

CfPA Courses Offer:• Topics from Introductory to Advanced

• Access to Leading Industry Experts

• An Informative and Interactive Learning Environment

• Practical Knowledge You Can Use to Improve Job Performance

• Application Oriented Real Life Case Studies

• Accreditation and Certification

www.cfpa.com

Limited

Seats Available.

Register Today!

NEW

NEW

Page 2: Accredited Technical Training for the … July-Sept PH catalog.pdfAccredited Technical Training for the Pharmaceutical, Cosmetic, Food and Medical Device Industries Course Catalog

Catalog Contents Page Page

Aerosol Technology 1

Analytical Methods Validation for FDA Compliance 1

Antiperspirants & Deodorant Technology 2

Applied cGMPs for Pharmaceutical & Allied Industries 2

Atomization, Sprays and Atomizers 3

Calibration in the FDA Regulated Industry 3

cGMP Auditing - Strategies for Compliance 4

CMC Submissions in CTD Format 4

Cosmetic Product Formulation 5

Critical Process Cleaning and Cleaning Validation 5

Crystallization Technology 6

Documentation Management and Control 6

Excipient GMPs 7

Food Extrusion Technology 7

Globally Harmonized Systems (GHS) 8

Granulation, Tabletting and Capsule Technology 8

Gums and Hydrocolloids 9

Hair Product Development 9

ICH Q10: Pharmaceutical Quality System 10

INDs, NDAs vs CTDs Global Regulations 10

Ingredients for Cosmetics and Toiletries 11

ISO 13485, ISO 9001 and QSR Regulations for 11 Medical Device Companies

Microencapsulation and Particle Coating 12

Non-Clinical Drug Safety Evaluation and Drug Development 12

Patent Law for Managers, Engineers and Scientists 13

Pharmaceutical Process Development 13

Pharmaceutical Quality Assurance and Control 14

Pneumatic Conveying for Bulk Solids 14

Preparing for and Surviving an FDA Inspection 15

Process Analytical Technology (PAT) 15

Process Validation for Packaging of Pharmaceuticals 16and Medical Devices

REACH: Registration, Evaluation and Authorization of Chemicals 16

Regulatory Compliance for the Personal Care Products Industry 17

Sensory Evaluation 17

Siloxane Technology & Personal Care Applications 18

Skin Product Development 18

Sterile Products: Formulation, Manufacture and Quality Assurance 19

Sunscreen Technology and Product Development 19

Tablet Production for Operators and Supervisors 20

General Information 21

WelcomeFor over 40 years CfPA has been meetingthe needs of professionals in the pharma-ceutical, biotechnology, cosmetic, medicaldevice and food industries with the mostcomprehensive selection of accreditedtechnical training programs available any-where. Our curriculum of over 350 coursesin 18 industries cover basic to advanced topics in Regulatory, Quality Assurance,Manufacturing, and Research. Choose acourse from a variety of formats to fit yourprofessional lifestyle: public, client site oronline.

We look forward to seeing you at anupcoming course.

Online TrainingCfPA’s Online Training program offers anew way to experience CfPA’s AccreditedTechnical Training and is the perfect complement to our public and client sitecourses. Now you can easily access theknowledge you need through the Internetto improve your performance on the joband increase your value to your employer.For more information on upcoming Liveand On-Demand courses, visit our websiteat:

www.cfpa.com/online-training or E-mail: [email protected]

Client Site TrainingTake advantage of the benefits Client Site training offers: cost effective, convenient, customized one-on-one atten-tion. Any course in this listing can bebrought to your company and tailored to your specific needs. For further informa-tion, please contact Client Site Programs:

732.238.1600 ext. 4549or E-mail: [email protected]

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Page 3: Accredited Technical Training for the … July-Sept PH catalog.pdfAccredited Technical Training for the Pharmaceutical, Cosmetic, Food and Medical Device Industries Course Catalog

1For course information, go to www.cfpa.comPlease note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

Analytical Methods Validation for FDA Compliance ID: 1887 Offering #: 0809-201

September 8–10, 2008 • Burlingame, CAWho Should Attend: This course is intended for individuals who have the responsibility for establishing theintegrity of analytical methods for active pharmaceutical ingredients (APIs) or finished pharmaceutical dosageforms. This course will benefit individuals in:• R&D • Quality Control • Technical Operations • Quality AssuranceRegulatory affairs personnel responsible for the review of such data will also benefit from this course.

Course Summary: One of the most critical factors in developing and marketing pharmaceutical drug sub-stances and drug products today is ensuring that the analytical methods used for analysis can generate validdata upon which business and regulatory decisions can be made. FDA, ICH and USP have each recognizedthe importance of this to the drug development process and have separately expanded method validationrequirements in recent years. However, with only limited guidance, industry has been left to interpret how toadequately comply with the regulations. Whether involved in method development, method validation, method optimization or method transfer, thiscourse will provide a broad understanding and “hands-on” knowledge of the method validation process andthe difficulties encountered in validating methods to comply with today’s upgraded FDA CDER requirements.Lectures will include not only theoretical basis and practical applications, but actual validation examples ofHPLC, GC, UV/Vis, AA, and titration methods for small organic molecules. Some of the more commonmathematical and statistical treatments of validation data will also be discussed. Because of the tremendouseffort that can be expended in conducting validation studies, efficiency of experimental design and documen-tation will be stressed throughout the discussions.Although the general principles in this course may be applied to methods for testing biological molecules andmedical devices, the focus of this course is on the validation of methods for the analysis of small molecules.

Course Co-Directors:J. Mark Green, Ph.D., Principal Investigator, Bristol-Myers Squibb Medical ImagingDavid E. Wiggins, Associate Director of Analytical/Stability R&D, Schering-Plough Consumer Health Care Products

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*) (Must register and pay by July 14, 2008)

Regular Registration: U.S. $1940 ($1860 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement (CfPA)is accredited by the Accreditation Council forPharmacy Education as a provider of continuingpharmacy education. Continuing Education Units

(CEU) will be awarded only upon successful completion of thecourse, i.e., attendance at essentially all the formal sessions andsubmission of a course evaluation. The CEU rate is 0.1 CEU percontact hour; certificate will be mailed within six weeks. You willhave an opportunity to evaluate your successful completion ofthese course objectives through a Learning Assessment.This offering is Program# 716-000-06-003-L04

This course (#07-1812)has been approved for3.0 Certification

Maintenance Points by The American Board of IndustrialHygiene (ABIH) for recertification.

(Please refer to page 21 for full description of each Accreditation)

Aerosol Technology ID: 669 Offering #: 0807-304

July 15–18, 2008 • Northbrook, ILWho Should Attend: This course will be of interest to those professionals who wish to develop an understanding of the most current developments in aerosol technology, as well as those who are actively involved in aerosol technology. This includes, but is not limited to:

• Chemists • Engineers • Scientists • Technologists

Course Summary: This course has been designed to cover the major aspects of aerosol technology and to instruct you in the successful formulation of aerosols for use in personal care products (deodorants, hairspray and shaving lathers), household products (room deodorants and disinfectants), automotive products(cleaners, lubricants and refrigerants), paints, food products (including pan sprays), industrial/ institutionalproducts, insect sprays, and miscellaneous products. Lectures will consist of all aspects of aerosol formula-tion including: basic techniques, propellant theory and practice, component choices, physicochemical prob-lems, quality control and regulations. Regulations and restrictions of aerosol products by federal, state andlocal governments will be covered on the fourth day, together with toxicology and safety considerations.

Course Director:Dr. Montfort A. Johnsen, President, Montfort A. Johnsen & Associates, Ltd.

Tuition:Early Registration (SAVE $200): U.S. $2155 ($2055 with Group Rate*)

(Must register and pay by May 20, 2008)

Regular Registration: U.S. $2355 ($2255 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONSThe Center for ProfessionalAdvancement (CfPA) offersmany courses which have

a chemical component. Such courses may earn up to 20 Certification Units toward certification by The NationalCertification commission in Chemistry and ChemicalEngineering, sponsored by The American Institute ofChemists.

(Please refer to page 21 for full description of each Accreditation)

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Antiperspirants and Deodorant Technology: Principles & Applications ID:1915 Offering #: 0807-310

July 17–18, 2008 • New Brunswick, NJWho Should Attend: The course would be of value to those working with cosmetic/toiletry productsfocused on antiperspirants and deodorant applications, as well as to those in industry and researchlaboratories interested in a basic understanding of the technologies and clinical aspects of the applica-tion of these products.

Though the course is intended primarily for entry level development technologists, the broad range of materials covered should provide an up-to-date refresher for experienced individuals. Chemists,microbiologists, analytical scientists and process engineers from the field of cosmetics, toiletries,pharmaceuticals, bioengineering and food industries will also benefit from the opportunity to under-stand more about regulations, formulations and process parameters for an FDA regulated product.

Course Summary: This course is intended to provide a comprehensive review of the regulatory andphysiological fundamentals of antiperspirants and deodorants. There will be significant emphasis onthe chemistry of antiperspirant and deodorant actives, how they function to inhibit odor or restrictsweat production, what are the acceptable protocols and statistics for measuring clinical efficacy of these actives and the basic parameters for developing functional products that match consumerneeds.

The instructors, both with many years of expertise in this area, will present the latest available information and trends regarding the field of antiperspirants and deodorants. Though the course will be structured, there will be open discussion and opportunities to address the specific problems and needs of participants.

Course Director:Eric S. Abrutyn, Senior Principal Scientist, Kao Brands Company

Tuition:Early Registration (SAVE $200): U.S. $1275 ($1215 with Group Rate*) (Must register and pay by May 22, 2008)

Regular Registration: U.S. $1475 ($1415 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONS

2 For course information, go to www.cfpa.comPlease note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

Applied cGMPs for Pharmaceutical and Allied Industries ID: 610 Offering #: 0809-204

September 8–10, 2008 • New Brunswick, NJWho Should Attend: This is an ideal course to acquire current applications of cGMPs. It offers latitude fordiscussion of fundamental as well as evolving regulatory initiatives and other complex issues. The course isdistinguished for benefit to domestic as well as non-US enterprises, including the following:

Positions – Analysts, Directors, Engineers, Executives, Investigators, Internal Auditors, Managers,Operators, QA/QC, Research, Supervisors, and Trainers

Industries – Academia, Biogeneric, Biological, Biopharmaceutical, Combination Product Manufacturers,Consultants, Contract Manufacturing, Dietary Supplements, Health Care, Legal Pharmaceutical,Regulatory, and Many Others.

Course Summary: This course takes you through Current Good Manufacturing Practice (cGMP) in thepharmaceutical and allied industries. Topics covered include legal requirement for cGMP in the Federal Food,Drug, and Cosmetic Act and related regulations. It addresses practical aspects of personnel, facilities, equip-ment, components, manufacturing, laboratory, packaging, labeling and QA/QC and provides an excellentforum for training personnel in cGMPs. The faculty consists of individuals with long and distinguished experi-ence in the field. Throughout this course, the relevance of FDA inspections commonly surfaces. There isspecial emphasis on discussing procedures and practices of the regulatory agency to help firms comprehendmanagement of FDA relationships.

Course Director:Wayne A. Mazanec, Former FDA Asssistant Regional Director–Pacific Region, and Regulatory Consultant

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*) (Must register and pay by July 14, 2008)

Regular Registration: U.S. $1940 ($1860 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement (CfPA)is accredited by the Accreditation Council forPharmacy Education as a provider of continuingpharmacy education. Continuing Education Units

(CEU) will be awarded only upon successful completion of thecourse, i.e., attendance at essentially all the formal sessions andsubmission of a course evaluation. The CEU rate is 0.1 CEU percontact hour; statement of credit will be mailed within six weeks.You will have an opportunity to evaluate your successful comple-tion of these course objectives through a Learning Assessment.This offering is Program# 716-000-07-178-L04

(Please refer to page 21 for full description of each Accreditation)

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(Please refer to page 21 for full description of each Accreditation)

The Center for ProfessionalAdvancement (CfPA) offers

many courses which have a chemical component. Suchcourses may earn up to 20 Certification Units towardcertification by The National Certification Commission inChemistry and Chemical Engineering, sponsored by TheAmerican Institute of Chemists.

Page 5: Accredited Technical Training for the … July-Sept PH catalog.pdfAccredited Technical Training for the Pharmaceutical, Cosmetic, Food and Medical Device Industries Course Catalog

3For course information, go to www.cfpa.comPlease note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

Calibration in the FDA Regulated Industry ID: 2026 Offering #: 0809-101

September 4–5, 2008 • New Brunswick, NJWho Should Attend: This overview course is intended for individuals in all industries, but specifically individuals in FDA regulated industries, who are responsible for establishing, maintaining, operating a cali-bration program, and audit of calibration activities, including:• Quality Assurance • Quality Control• Quality Engineering • Technical Support• Research and Development • Facilities and Equipment Maintenance

Course Summary: The regulations covering manufacture and control of drug products and medicaldevices require that firms have a program for the calibration of test and measurement equipment. A requirement for calibration is also defined in ISO 9000 and a Quality System for a calibration laboratoryis described in ISO 17025. Calibration is a good business and science practice followed in all industriesthat require measurements for process monitoring and control. The program must include the elementsof: calibration intervals, scheduling, specific calibration procedures, limits of accuracy and precision andremedial action in the event that the instrument does not meet established requirements.This course addresses the regulatory and business requirements for calibration as an element of a QualitySystem and how these requirements support the increasing application of process monitoring andsophisticated laboratory instrumentation, along with the maturing discipline of calibration in the regulatedindustries. It includes a discussion of a compliant calibration program and concludes with a discussion of a model calibration procedure.

Course Director:Dr. Jerry Lanese, President, The Lanese Group, Inc.

Tuition:Early Registration (SAVE $200): U.S. $1275 ($1215 with Group Rate*) (Must register and pay by July 10, 2008)

Regular Registration: U.S. $1475 ($1415 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONS

The Center for Professional Advancement (CfPA)is accredited by the Accreditation Council forPharmacy Education as a provider of continuingpharmacy education. Continuing Education Units

(CEU) will be awarded only upon successful completion of thecourse, i.e., attendance at essentially all the formal sessions andsubmission of a course evaluation. The CEU rate is 0.1 CEU percontact hour; certificate will be mailed within six weeks. You willhave an opportunity to evaluate your successful completion ofthese course objectives through a Learning Assessment.This offering is Program# 716-000-07-305-L04

The American Association of Family andConsumer Sciences has approved thiscourse for 12 Professional DevelopmentUnits.

(Please refer to page 21 for full description of each Accreditation)

Atomization, Sprays and Atomizers ID: 1883 Offering #: 0808-204

August 7–8, 2008 • New Brunswick, N JWho Should Attend: This course is for professionals in the chemical, biotechnology, agriculturalsprays, food, pulp and paper, combustion and medical areas. Those involved with spray-dependentprocesses, including chemical reactors, coatings, spray drying, powder metallurgy, evaporative cool-ing, specialty chemicals, combustion and medical sprays will benefit including:

• Biotechnologists • Coating Engineers• Food Technologists • Combustion Engineers• Agricultural Engineers

Course Summary: Atomization is an important process used in many industries, including chemical,petrochemical, biochemical, medical, food, paper, combustion, fuels, and agriculture. This course provides an introduction to atomization for engineers, scientists and technologists who are interestedin or need to know more about atomization, atomizer design, atomizer specifications and selection for various applications.

Key areas to be covered include the various atomization methods, atomizer design, factors affecting operation, flow in atomizers, drop size, spray angle and other spray characteristics, atomizer performance criteria, atomizer maintenance and drop size distributions. Proper atomizer selection will beemphasized. Worked problems on flow number for nozzles and the air-to-liquid ratio for two fluid atomizers will be presented in class. Calculations for spray dryers will also be reviewed.

The course will follow a lecture/discussion/video presentation format. Demonstrations of the use of the atomization equipment and maintenance procedures will be shown.

Course Director:Dr. Gary B. Tatterson, Professor, Chemical Engineering North Carolina A&T State University

Tuition:Early Registration (SAVE $200): U.S. $1275 ($1215 with Group Rate*) (Must register and pay by June 12, 2008)

Regular Registration: U.S. $1475 ($1415 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONS

(Please refer to page 21 for full description of each Accreditation)

Page 6: Accredited Technical Training for the … July-Sept PH catalog.pdfAccredited Technical Training for the Pharmaceutical, Cosmetic, Food and Medical Device Industries Course Catalog

4 For course information, go to www.cfpa.comPlease note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

CMC Submissions in CTD Format ID: 1989 Offering #: 0808-203

August 4–5, 2008 • New Brunswick, NJWho Should Attend: This course is intended for all personnel in pharmaceutical companies especially those in:

• Regulatory Affairs• Chemistry and Analytical Departments• Pre-formulation• Pharmaceutical Development• QA/QC for the CMC section of the NDA/CTD

It is recommended that you have at least one year experience in either regulatory affairs, chemistry, ana-lytical, QA/QC or pharmacy department or pharmaceutical development to fully benefit from this course.

Course Summary: This course will provide an in depth review of the chemistry, manufacturing and con-trols (CMC) requirements for development and ultimate submission to the FDA and European regulatorybodies in the new drug application (NDA). Emphasis will be placed on current FDA, European and ICHrequirements for the filing of the quality section of the CTD for manufacturing, analytical, sterility and stability issues as they apply to the drug substance and drug product. In addition, details on supplementalapplications for changes to an NDA will be presented focusing on SUPAC requirements.

Course Director:Carolyn H. Kruse, MSc., M.TOPRA, Consultant to the Pharmaceutical Industry, Kruse Consulting Group

Tuition:Early Registration (SAVE $200): U.S. $1275 ($1215 with Group Rate*) (Must register and pay by June 9, 2008)

Regular Registration: U.S. $1475 ($1415 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement(CfPA) is accredited by the AccreditationCouncil for Pharmacy Education as a providerof continuing pharmacy education. Continuing

Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially all the formal sessions and submission of a course evaluation. The CEU rate is 0.1 CEU per contact hour; statement of credit will be mailed within six weeks. You will have an oppor-tunity to evaluate your successful completion of these courseobjectives through a Learning Assessment. This offering isProgram# 716-000-07-313-L04

(Please refer to page 21 for full description of each Accreditation)

cGMP Auditing - Strategies for Compliance ID: 2012 Offering #: 0808-305

August 11, 2008 • New Brunswick, NJWho Should Attend: Newly assigned auditors or those who expect to be involved in auditing in thenear future, will find this course beneficial. Those individuals who expect their departments, groups orfunctions to be audited will also find the program of great interest. The material in this course can be help-ful to professionals in a variety of functions, such as:

• Quality Assurance • Packaging • Production • Vendors/Suppliers• Quality Control • Documentation Control • Engineering• Regulatory Compliance • Laboratory • Purchasing

Course Summary: This practical, introductory course was designed to provide a mechanism for thoseinterested in understanding the basic requirements for auditing in the pharmaceutical and related indus-tries. The course presents an introduction to the evolutionary process of FDA regulations and describesin detail the latest FDA initiatives in the inspection process. It provides a road map for auditors in settingup a cGMP audit trail from beginning to end. Specific compliance aspects like change control, outsourc-ing, and validation will be presented as they pertain to the audit function. The course will consist of lectures, interactive discussions and a hands-on workshop.

Course Director:Renée B. Galkin, Quality Management Consultant

Tuition:Early Registration (SAVE $100): U.S. $950 ($905 with Group Rate*) (Must register and pay by June 16, 2008)

Regular Registration: U.S. $1150 ($1105 with Group Rate*)

Attend this course and it’s companion course Preparing and Surviving an FDA Inspection (ID# 187) and save $300†.

See page 15 for course description. †Discount applies only to combined regular tuition.

ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement (CfPA)is accredited by the Accreditation Council forPharmacy Education as a provider of continuingpharmacy education. Continuing Education Units

(CEU) will be awarded only upon successful completion of thecourse, i.e., attendance at essentially all the formal sessions andsubmission of a course evaluation. The CEU rate is 0.1 CEU percontact hour; certificate will be mailed within six weeks. You willhave an opportunity to evaluate your successful completion ofthese course objectives through a Learning Assessment.This offering is Program# 716-000-07-202-L04

(Please refer to page 21 for full description of each Accreditation)

The Center for ProfessionalAdvancement (CfPA) offers

many courses which have a chemical component. Suchcourses may earn up to 20 Certification Units towardcertification by The National Certification Commission inChemistry and Chemical Engineering, sponsored by TheAmerican Institute of Chemists.

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5For course information, go to www.cfpa.comPlease note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

Critical Process Cleaning and Cleaning Validation ID: 1867 Offering #: 0807-202

July 7–9, 2008 • Burlingame, CAWho Should Attend: This course is intended for professionals in:• Process Engineering • Production • Quality Assurance • Validation• Technical and management positionsYou should have some familiarity and experience with the basic subject as it applies to research and man-ufacturing of pharmaceuticals, personal care products, nutritional materials and fine chemicals.

Course Summary: This course will provide a solid overview of the principles and technology of residueremoval and residue measurement on product contact surfaces. It will address the latest issues, industrypractices and compliance strategies regarding choice of cleaning techniques, cleaning agents, analyticalmethods, residue challenges, grouping strategies and validation protocols. Examples of current industrycleaning validation practices and case histories will be presented. Recent FDA inspection history and regulatory comment regarding these issues will be discussed in depth.This practical course will help participants familiar with this topic to better evaluate and develop their ownFDA regulated cleaning programs that balance production objectives against QA/validation objectives.The idea is to first achieve an effective reliable cleaning process, then generate sufficient data and justifi-cation without going overboard on the number of samples, the number of analytical tests and the numberof qualification studies that have become an excessive burden to many firms.Participants are encouraged to bring a cleaning problem to the course for inclusion in the “ParticipantProblem Clinic” on the second day.

Course Director:Steven A. Weitzel, Technical Director, Critical Process Cleaning, Inc.

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*) (Must register and pay by May 12, 2008)

Regular Registration: U.S. $1940 ($1860 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement (CfPA)is accredited by the Accreditation Council forPharmacy Education as a provider of continuingpharmacy education. Continuing Education Units(CEU) will be awarded only upon successful com-

pletion of the course, i.e., attendance at essentially all the formalsessions and submission of a course evaluation. The CEU rate is0.1 CEU per contact hour; statement of credit will be mailed withinsix weeks. You will have an opportunity to evaluate your success-ful completion of these course objectives through a LearningAssessment. This offering is Program# 716-000-08-004-L04

This course (#07-1811) hasbeen approved for 3.0Certification Maintenance

Points by The American Board of Industrial Hygiene (ABIH) forrecertification.

This course meets Board of Certified Safety Professionals(BCSP) criteria for points toward the Continuance ofCertification requirements

(Please refer to page 21 for full description of each Accreditation)

Cosmetic Product Formulation ID: 1350 Offering #: 0808-202

August 4–6, 2008 • New Brunswick, NJWho Should Attend: Individuals in the cosmetic/toiletries industry who seek to broaden their knowledgeof development, evaluation, and performance of a variety of products will find this course very beneficial.

Technical personnel in service and allied functions in the cosmetic/toiletries field who are not directlyinvolved in product development but require a better understanding of the development process will alsofind this course of value. These would include:

• Analytical chemists • Process engineers/chemists• Safety and regulatory specialists • Microbiologists

Marketing personnel with sufficient technical background should also find this course helpful in theirinteractions with research and development.

Course Summary: This course will review the methodologies used to develop the major types of cosmetic and toiletries products. Idea generation,formulation development, manufacturing considerations, and stability testing will be discussed for each product type. The basis in the development of stable emulsions will also be discussed. Among the product types to be reviewed will be: creams, lotions, hair products (including shampoos, conditioners, waving products, and grooming products), makeup products, shaving products, soaps and related washing products.

Particular attention will be given to critical problem areas which can affect the development process as well as the effects of specific ingredients on product performance, stability, and product scale-up.

Course Director:John Carson, Principal, Carson Product Development, Inc.

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*) (Must register and pay by June 9, 2008)

Regular Registration: U.S. $1940 ($1860 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONS

(Please refer to page 21 for full description of each Accreditation)

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6 For course information, go to www.cfpa.comPlease note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

Documentation Management and Control ID: 1866

July 14–15, 2008 • Burlingame, CA September 15-16, 2008 • New Brunswick, NJWho Should Attend: This basic introductory course is designed for individuals responsible for documenta-tion writing and management in the pharmaceutical and related industries. The course will benefit individualsin a variety of functions such as:• Quality Assurance • Regulatory • Quality Control • Production• R&D • Product Development • Toxicology • Vendors/Suppliers• Clinical Research • CRO’s

Course Summary: FDA regulations such as Good Manufacturing Practice (GMP) for drugs and medicaldevices, Good Laboratory Practice (GLP), Good Clinical Practice (GCP), as well as quality system stan-dards like ISO 9000, require that documentation, such as standard operating procedures, plans and varioustypes of records, be in place. These regulations, however, do not provide any guidelines to the industry onhow to set up and manage documentation systems. It is, therefore, left to companies to design and set uptheir own internal documentation systems.This course provides hands-on methodology and techniques on how to identify what systems require docu-mentary coverage; how to flowchart operations to identify what type of documentation is required; and howto set up, implement and manage the maintenance of such documentation systems to ensure continuouscompliance. Types of documentation addressed include: quality manuals, policy manuals, standard operat-ing procedures, work instructions, forms, records, logs, protocols, etc. The course also covers areas relat-ed to computer validation documentation, such as validation protocols and 21 CFR Part 11—ElectronicRecords and Signatures. Emphasis is placed on controls that need to be in place to ensure proper manipu-lation of documentary systems.

Course Director:Renée B. Galkin, Quality Management Consultant

Tuition:Early Registration (SAVE $200): U.S. $1275 ($1215 with Group Rate*) (Must register and pay by May 19, 2008 for CA offering, and by July 21, 2008 for NJ offering)

Regular Registration: U.S. $1475 ($1415 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement (CfPA)is accredited by the Accreditation Council forPharmacy Education as a provider of continuingpharmacy education. Continuing Education Units(CEU) will be awarded only upon successful com-

pletion of the course, i.e., attendance at essentially all the formalsessions and submission of a course evaluation. The CEU rate is0.1 CEU per contact hour; certificate will be mailed within sixweeks. You will have an opportunity to evaluate your successfulcompletion of these course objectives through a LearningAssessment. This offering is Program# 716-000-07-119-L04

The American Association of Family andConsumer Sciences has approved this coursefor 12 Professional Development Units.

This course (#07-1810) hasbeen approved for 2.0Certification Maintenance

Points by The American Board of Industrial Hygiene (ABIH)for recertification.

CfPA is a program sponsor approved by the PennsylvaniaBoard of Accountancy #PX-002022-L. This course has beenapproved for these purposes.

(Please refer to page 21 for full description of each Accreditation)

Crystallization Technology ID: 149 Offering #: 0807-503

July 28–30, 2008 • New Brunswick, NJWho Should Attend: The course is intended for engineers, chemists and technicians involved withthe design, analysis or operation of organic or inorganic crystallization processes at the bench-scale,pilot plant or commercial-scale level including:• Design Technologists • Plant Operation Technologists• Process Development Technologists • Vendor Testing• Pilot Plant TechnologistsTheir supervisors and others working with them can profit from a detailed practical knowledge of crystallization technology.

Course Summary: This course provides a practical treatment of crystallization technology, presentedin light of the many recent advances in the understanding of crystallization processes. Emphasis willbe given to the practical problems of crystallizer operation, and a logical way of understanding thepotential and limitations of crystallizer performance will be presented. Both organic and inorganic systems will be treated in batch and continuous mode. Elementary topics in the analytical descriptionof particle-size distributions will be presented. The treatment will not emphasize the mathematics ofparticle distributions, but rather the basic principles involved and the results that can be applied.

Practical problems to be considered are Crystal Size Distribution (CSD) and its interaction with crystal habit, purity, and fouling; secondary nucleation; crystallizer configuration, e.g., seeding, classification, fines removal, scale-up considerations, the impact of mixing, polymorphism, crystallizer transients and stability, and online measurement of crystallization parameters. Efficient techniques for scanning crystal growth, nucleation and habit modifiers will be discussed. These problems will be considered from both analytical and operational points of view.

Participants are asked to bring a hand-held calculator to the course.

Course Director:Wayne J. Genck, President, Genck International

Tuition:Early Registration (SAVE $200): U.S. $1940 ($1860 with Group Rate*) (Must register and pay by June 2, 2008)

Regular Registration: U.S. $2140 ($2060 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONS

(Please refer to page 21 for full description of each Accreditation)

CA Offering #: 0807- 301NJ Offering #: 0809-301

The Center for ProfessionalAdvancement (CfPA) offers

many courses which have a chemical component. Suchcourses may earn up to 20 Certification Units towardcertification by The National Certification Commission inChemistry and Chemical Engineering, sponsored by The American Institute of Chemists.

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For course information, go to www.cfpa.com 7Please note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

Excipient GMPs ID: 2050 Offering #: 0807-401

July 21–23, 2008 • New Brunswick, NJWho Should Attend: This course is intended for chemical manufacturers who want to learn about supplying excipients to the industry and for those manufacturers already supplying excipients that need to learn about excipient GMP compliance. It is also intended for pharmaceutical manufacturers that mustassess the compliance of their excipient suppliers to appropriate GMP requirements.Personnel in the following areas have found this course beneficial:

• Quality Assurance • Quality Control• Regulatory Affairs • Quality Audit• New Business Development

Course Summary: This course will cover the regulatory, quality, and manufacturing issues involved inproviding chemicals for use as excipients (inactive ingredients) in the manufacture of drug products.Youwill learn about the regulation of chemicals sold for use as excipients by the FDA, the expectations of thepharmaceutical industry, and excipient quality system requirements (GMP). There will also be topical infor-mation on current issues facing the industry.

Course Director:Irwin Silverstein, Ph.D., President, IBS Consulting in Quality LLC., Chief Operating Officer ,International Pharmaceutical Excipients Auditing Inc.

Tuition:Early Registration (SAVE $200): U.S. $1800 ($1600 with Group Rate*) (Must register and pay by May 26, 2008)

Regular Registration: U.S. $2000 ($1800 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONS

The Center for Professional Advancement(CfPA) is accredited by the AccreditationCouncil for Pharmacy Education as a providerof continuing pharmacy education. Continuing

Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially all the formal sessions and submission of a course evaluation.The CEU rate is 0.1 CEU per contact hour; certificate will bemailed within six weeks. You will have an opportunity to evalu-ate your successful completion of these course objectivesthrough a Learning Assessment. This offering is Program#716-000-08-430-L04

(Please refer to page 21 for full description of each Accreditation)

Food Extrusion Technology ID: 689 Offering #: 0808-502

August 25–27, 2008 • Burlingame, CAWho Should Attend: This course is designed to explain the fundamentals of food extrusion and illustratethe application to food processing operations. The program will be of particular value to:• Food scientists, technologists, technicians and engineers working in R&D and Operations involved

with food extruders• Individuals employed by cereal, snack, pet food, confectionery, modified starches and

proteins manufacturersThe course will also appeal to professionals working in allied industries, equipment manufacturers, and ingredient suppliers involved with food extrusion.

Course Summary: Food extrusion has become a very important processing operation. Today, the foodextruder is used to produce pasta and other cold formed products, ready-to eat cereals, snacks, petfood, confectionery products, modified starches for soup, baby food and instant foods, beverage basesand texturized vegetable proteins. This course is designed to provide a thorough background in extrusionprinciples and practice. Details of both single and twin screw extrusion of foods will be covered. Emphasiswill be placed on describing the basic scientific and process engineering principles to extrusion operationin a simple, clear and concise approach that enables good understanding of the extrusion process. This fundamental approach will lead directly to the discussion of the control and operation of extrudersto optimize production and product quality. The chemical nature and modifications of food components making up the ingredients commonly used in extrusion operations will be described. Combined with a better understanding of extrusion principles, the course should lead to better controlled and optimum extrusion operation.

Course Director:Dr. Waleed A. Yacu, President, The Yacu Group Inc.

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*) (Must register and pay by June 30, 2008)

Regular Registration: U.S. $1940 ($1860 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONS

The American Association of Familyand Consumer Sciences has approvedthis course for 18 ProfessionalDevelopment Units.

(Please refer to page 21 for full description of each Accreditation)

The Center for ProfessionalAdvancement (CfPA) offers

many courses which have a chemical component. Suchcourses may earn up to 20 Certification Units towardcertification by The National Certification Commission inChemistry and Chemical Engineering, sponsored by The American Institute of Chemists.

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Please note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

Granulation, Tabletting & Capsule Technology ID: 541 Offering #: 0808-401

August 18–21, 2008 • Burlingame, CAWho Should Attend: This broadly based course is intended for all scientists and technologists con-cerned with the development and processing of tablets, capsules and similar products, and with relateddrug regulatory affairs.The material will be presented in such a way as to be of value to a varying level of expertise. This coursewill especially benefit those in:

• Quality Assurance • R&D • Marketing • Regulatory Affairs

• Validation • Manufacturing/Production • Purchasing • Engineering Support

Course Summary: The main aim of this course is to review the science relating to tabletted and encap-sulated pharmaceutical products. The course begins with a consideration of raw material testing and thebasic aspects of powder and granulation technology, progresses through formulation of solid dosageforms to manufacturing processes and equipment including scale-up and technology transfer. The pro-gram concludes with key aspects of the evaluation of finished products and the regulatory constraintsthat must be considered at each stage. Formal sessions of the course are supplemented with informaldiscussion periods between lecturers and course participants and problem-solving sessions are held onboth an open and private basis.

Course Director:Dr. Cecil W. Propst, Director of R&D, SPI Pharma Group, Grand Haven

Tuition:Early Registration (SAVE $200): U.S. $2155 ($2055 with Group Rate*)(Must register and pay by June 23, 2008)

Regular Registration: U.S. $2355 ($2255 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement(CfPA) is accredited by the AccreditationCouncil for Pharmacy Education as a providerof continuing pharmacy education. ContinuingEducation Units (CEU) will be awarded only

upon successful completion of the course, i.e., attendance atessentially all the formal sessions and submission of a courseevaluation. The CEU rate is 0.1 CEU per contact hour; state-ment of credit will be mailed within six weeks. You will have anopportunity to evaluate your successful completion of thesecourse objectives through a Learning Assessment.This offering is Program# 716-000-07-139-L04

The Center for ProfessionalAdvancement (CfPA) offersmany courses which have

a chemical component. Such courses may earn up to 20Certification Units toward certification by The NationalCertification Commission in Chemistry and ChemicalEngineering, sponsored by The American Institute ofChemists.

(Please refer to page 21 for full description of each Accreditation)

8 For course information, go to www.cfpa.com

Globally Harmonized Systems (GHS) ID: 2201 Offering #: 0809-308

September 15–16, 2008 • New Brunswick, N JWho Should Attend: This course is designed to provide a comprehensive perspective on globalchemical and product lifecycle management strategy. In particular, this course offers a detailed reviewof the most recent European Globally Harmonized Systems (GHS) legislation and how it relates to relevant international GHS systems, chemical regulations and hazard communication. It is designed for professionals involved in all aspects of chemical applications for a wide range of product develop-ment, within the cosmetic, chemical and pharmaceutical industries including:

• Research and Development• Technology, Formulation and Product Development• Marketing and Technical Sales• Business Decision Makers• Regulatory Affairs• EHS, QA and QC Professionals

Course Summary: This course will provide an in depth overview of the EU's GHS regulation and comparable global GHS implementation for professionals involved in chemical applications for all aspects of product development with business interests in the European Union. The participants will get an overall understanding of the REACH-GHS inter-relationship in order to form a comprehensive chemical/product lifecycle management programs for their companies. The course has a main focus on EU's GHS system, but will also introduce in depth comparison and contrast to other comparable GHS systems globally. Small group discussion/workshops will be conducted throughout the course to familiarize the participants with the implementation requirements of GHS.

Course Director:Wen Schroeder, President, SEKI Cosmeticals, LLC

Tuition:Early Registration (SAVE $200): U.S. $1275 ($1215 with Group Rate*) (Must register and pay by July 21, 2008)

Regular Registration: U.S. $1475 ($1415 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONS

(Please refer to page 21 for full description of each Accreditation)

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Page 11: Accredited Technical Training for the … July-Sept PH catalog.pdfAccredited Technical Training for the Pharmaceutical, Cosmetic, Food and Medical Device Industries Course Catalog

9For course information, go to www.cfpa.comPlease note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

Hair Product Development ID: 2076 Offering #: 0808-201

August 7–8, 2008 • New Brunswick, NJWho Should Attend: This course is intended for beginner formulators or marketingpersonnel and those with some experience who have the desire to quickly widen their level of knowledgeand become familiar with the marketing, technical and claim substantiation issues related to hair productdevelopment such as:

• Analytical chemists • Microbiologists

• Scientists • Technicians

Personnel in research and development, sales, marketing, and labeling will find this course very valuable.

Course Summary: This course provides a review of the main marketing trends in hair care, followed byan analysis of the fundamental properties of human hair as related to cosmetic treatments. A thoroughreview of the foremost raw materials presently used in the industry will be discussed so that the formulators and marketing professionals will quickly become familiar with the products, properties and raw material supplied to the hair care area of the cosmetic industry. In addition, the main technologies and challenges relevant to product development in the areas of shampoos, conditioners, styling products, hair colorants, relaxers, etc., will be explained. A critical analysis of the methodology used for claim substantiation in hair care will also be addressed. An all-participants interactive session has been developed that is dedicated to the design of typical hair care products from the knowledge gained within the course.

Course Director:Manuel Gamez-Garcia, Ph.D., Sr. Research Scientist, Ciba Specialty Chemicals

Tuition:Early Registration (SAVE $200): U.S. $1275 ($1215 with Group Rate*) (Must register and pay by June 12, 2008)

Regular Registration: U.S. $1475 ($1415 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONS

(Please refer to page 21 for full description of each Accreditation)

Gums and Hydrocolloids ID: 1019 Offering #: 0808-303

August 11–13, 2008 • New Brunswick, NJWho Should Attend: Professionals who will derive the greatest benefit from this course are scientists with some background in the chemistry and rheology of gums in the following industries:• Food • Pharmaceutical • CosmeticThose with a more extensive background will also find this course valuable since the course takes a freshapproach to integrating chemistry, rheology and functionality to research and product development applications.

Course Summary: This course is designed for practicing food scientists and technologists who wish to develop a pragmaticknowledge of hydrocolloid technology and its utilization in food product development. Although pharmaceuti-cal and cosmetic applications are not specifically covered in this course, the principles presented are easilyextended to applications in those two fields.Almost all processed foods depend upon hydrocolloids, as additives, ingredient constituents or processingaids, for their functional, textural, and organoleptic properties. Current developments in such areas as low/nofat foods, fiber-enhanced foods and designer health foods are critically dependent upon hydrocolloids.This course will review the chemistry, properties and utility of contemporary food grade hydrocolloids andtheir functional applicability to traditional, novel and new product development.In addition to the formal program, you will have ample time to discuss your technical problems or interestswith the entire faculty, who have a combined total of well over 100 years of industrial experience.

Course Director:Alan H. King, Ph.D., Hydrocolloids Consultant, A.H. King Associates

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*) (Must register and pay by June 16, 2008)

Regular Registration: U.S. $1940 ($1860 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONS

The Center for ProfessionalAdvancement (CfPA) offersmany courses which have

a chemical component. Such courses may earn up to 20 Certification Units toward certification by The NationalCertification Commission in Chemistry and ChemicalEngineering, sponsored by The American Institute ofChemists.

(Please refer to page 21 for full description of each Accreditation)

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10 For course information, go to www.cfpa.com

Please note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

INDs, NDAs vs CTDs Global Regulations ID: 448 Offering #: 0809-406

September 22–24, 2008 • New Brunswick, NJWho Should Attend: This course is specifically designed for personnel in the pharmaceutical andbiotechnology industries who need a detailed understanding of what comprises an IND, NDA, BLA,ANDA, SNDA, and CTD. This includes but is not limited to those involved in:

• Pre-Clinical Research • CMC Components • Regulatory Affairs • Management• Clinical Research • Quality Assurance • Product DevelopmentParticipants should have a basic understanding of new product development and/or regulatory affairs inorder to best comprehend the lectures presented in this course.

Course Summary: The content of this course is designed to present the intricate parts of INDs, NDAs,BLAs, ANDAs, SNDAs and CTDs. These regulatory submissions for drug and biologic products will bebased on the requirements of the US Code of Federal Regulations, the ICH Guidelines for global submis-sions and the EU Directives. Specifics of the IND, NDA, BLA, ANDA, SNDA and CTD will be detailedfor safety, quality, and efficacy. Non and pre-clinical data, clinical data and CMC data to achieve productapprovals globally will be enumerated for expediting new product approvals. Other subject areas include:

• FDAs internal structure, policies, and procedures • GCP, GLP and GMP regulation requirements for INDs, NDAs, BLAs, ANDAs, SNDAs, CTDs and

Drug Master Files• The FDA review process for new product approvals, including FDA/Industry Meetings and Liaison• Acceptance of foreign data for new product approvals, EU Directives on global submissions.

Course Director:Dr. Richard A. Guarino, President, Oxford Pharmaceutical Resources, Inc.

Tuition:Early Registration (SAVE $200): U.S. $1910 ($1830 with Group Rate*) (Must register and payby July 28, 2008)

Regular Registration: U.S. $2110 ($2030 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement(CfPA) is accredited by the AccreditationCouncil for Pharmacy Education as a providerof continuing pharmacy education. Continuing

Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially all the formal sessions and submission of a course evaluation. The CEU rate is 0.1 CEU per contact hour; statement of credit will be mailed within six weeks. You will have an oppor-tunity to evaluate your successful completion of these courseobjectives through a Learning Assessment. This offering isProgram# 716-000-06-314-L04

(Please refer to page 21 for full description of each Accreditation)

ICH Q10: Pharmaceutical Quality System ID: 2131 Offering #: 0809-307

September 18–19, 2008 • New Brunswick, NJWho Should Attend: This course has been designed to benefit those in the Pharmaceutical industry withresponsibilities related to the design, operation or management of the overall Quality System or any individ-ual quality system used by the industry. The course is particularly suitable for personnel working in:• Site & Corporate Management • Production • Pre-Market Departments• Regulatory Affairs • Quality Units (including QA, QC & Quality Audit)The course is applicable to personnel in API, commodity and outsource suppliers to the industry in additionto those in primary manufacturers of drug products.

Course Summary: The draft of ICH Q10 is the latest document that aims to define the requirements for a quality system for pharmaceutical operations. It discusses how the function of the system should evolveduring pre-market operations, what its function is when a drug is marketed and how opportunities for prod-uct improvement should be identified and implemented throughout the product life cycle. The main elementdiscussed in Q10 is what management, especially senior management, should be responsible for in assur-ing an effective Quality System. Other important elements receiving an emphasis in Q10 are the QualitySystem components such as change control, deviation control, CAPA, root cause determination,input/process/output monitoring, product reviews and documentation.This course analyzes the content of Q10 and compares it with previous standards including the FDAGuidance on Quality Systems and ISO 9000. It analyzes its relationship with Q8 (Product Development) andQ9 (Risk Management) and the FDA Guidance on their Six-Systems Inspection Program and discusses thequality systems to which Q10 refers with particular reference as to how such systems can be effectivelymanaged & integrated in accordance with Q10.

Course Director:Alan J. Smith, Ph.D, Pharmaceutical Quality & Technology ConsultantWith Presentations by: John G. (Jerry) Lanese, Ph.D, President, The Lanese Group, Inc.

Tuition:Early Registration (SAVE $200): U.S. $1275 ($1215 with Group Rate*) (Must register and pay by July 24, 2008)

Regular Registration: U.S. $1475 ($1415 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement(CfPA) is accredited by the AccreditationCouncil for Pharmacy Education as a providerof continuing pharmacy education. Continuing

Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially all theformal sessions and submission of a course evaluation. TheCEU rate is 0.1 CEU per contact hour; statement of credit will be mailed within six weeks. You will have an opportunity to evaluate your successful completion of these course objec-tives through a Learning Assessment. This offering isProgram# 716-000-07-401-L04

(Please refer to page 21 for full description of each Accreditation)

The Center for ProfessionalAdvancement (CfPA) offersmany courses which have a

chemical component. Such courses may earn up to 20Certification Units toward certification by The NationalCertification Commission in Chemistry and ChemicalEngineering, sponsored by The American Institute ofChemists.

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11For course information, go to www.cfpa.com

Please note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

September 22–24, 2008 • New Brunswick, NJWho Should Attend: Participants who work in the medical device industry and who currently are or wishto sell their product in the US, Europe and other parts of the world will profit by attending this course. This includes professionals responsible for understanding and interpreting global regulations within theircompanies, in areas such as:• Regulatory • QA • R&D • Manufacturing

Course Summary: This course provides a detailed description of the current European and US regula-tions for medical devices. With the continued growth in the development and acceptance of global standards, all device companies must stay up to date on the various regulations to ensure marketability of their products globally. With 25 European countries now using the ISO 13485 standard, it is critical tocompanies to understand how the similarities and differences in these standards can be implemented into their own quality system to enhance their marketability. The primary focus of this course is on thedevelopment of one quality system which complies with the ISO 13485:2003 standard, ISO 9001:2000standard and the FDA Quality System Regulations. Participant interaction, problem solving and open discussion will be strongly encouraged.

Course Director:Bea Salis, Consultant, QualASyst International

Tuition:Early Registration (SAVE $200): U.S. $1840 ($1760 with Group Rate*) (Must register and pay by July 28, 2008)

Regular Registration: U.S. $2040 ($1960 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement(CfPA) is accredited by the AccreditationCouncil for Pharmacy Education as a providerof continuing pharmacy education. Continuing

Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially all the formal sessions and submission of a course evaluation. The CEU rate is 0.1 CEU per contact hour; statement of credit will be mailed within six weeks. You will have an oppor-tunity to evaluate your successful completion of these courseobjectives through a Learning Assessment. This offering isProgram# 716-000-08-001-L04

(Please refer to page 21 for full description of each Accreditation)

ISO 13485, ISO 9001 and QSR Regulations for Medical Device Companies ID: 2092 Offering #: 0809-404

18 Recertification Credits

Ingredients for Cosmetics and Toiletries ID: 971 Offering #: 0809-203

September 8–10, 2008 • New Brunswick, NJWho Should Attend: The course has been designed for all individuals who are involved directly orindirectly in the selection and/or utilization of ingredients for cosmetics. This includes experienced and entry level professionals from cosmetic companies and ingredient manufacturers.The course has proven to be beneficial to:• Formulation chemists and associated technologists• Processing and Packaging Engineers • Dermatologists• Sales and Marketing Staff • Pharmacologists• Microbiologists • Analytical Chemists

Course Summary: This course is intended to provide a comprehensive survey of ingredients funda-mental to the cosmetic industry. The presentations will emphasize current trends in the selection of cosmetic ingredients. The chemistry and technology of cosmetic raw materials will be related totheir behavioral properties as utilized in the construction of stable functional systems. In this way, it isintended to generate a better understanding of the contributions of ingredients to the performance offinished product formulations. Key ingredients to be examined will include emulsifiers, surfactants, fatty chemicals, emollients and moisturizers, powders, polymers, humectants, thickeners, preservatives and numerous other specialty chemicals. Emphasis will be placed on recognizing and dealing with problem areas associated with the use of various ingredients. Safety considerations and other pertinent matters which can influence ingredient selection will be included in these discussions.

Course Co-Directors:Richard J. Thabit, President, Thabit Associates, Inc.

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*) (Must register and pay by July 14, 2008)

Regular Registration: U.S. $1940 ($1860 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONS

(Please refer to page 21 for full description of each Accreditation)

The Center for ProfessionalAdvancement (CfPA) offers

many courses which have a chemical component. Suchcourses may earn up to 20 Certification Units towardcertification by The National Certification Commission inChemistry and Chemical Engineering, sponsored by The American Institute of Chemists.

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12 For course information, go to www.cfpa.comPlease note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

Non-Clinical Drug Safety Evaluation & Drug Development ID: 1153 Offering #: 0809-306

September 15–18, 2008 • Burlingame, CAWho Should Attend: This course is designed for a broad range of pre-clinical, clinical, management,investment, and regulatory personnel in both established and emerging pharmaceutical companies. It will be of special value to:• Scientists who wish to gain an understanding of pharmaceutical toxicity studies• Managerial personnel • Project management staff• Investors • Regulatory Scientist involved in preclinical development

Course Summary: This course provides a comprehensive explanation of the non-clinical develop-ment of drugs and biologics, emphasizing the principles of pharmaceutical toxicology and theassessment of product safety. In addition to the different types of toxicity studies in modern pharmaceutical development, it also describes the relationship between pharmacology, clinical trial design, regulatory strategy and project management.Emphasis will be placed on how toxicity studies are integrated into the multidisciplinary developmentplans of new drugs and biologics, and how they affect development decisions. Regulatory affairswill be covered, and descriptions given of the European and the U.S. FDA requirements, the newdrug review process, and common regulatory errors.The goal of this course is to give a working knowledge of pharmaceutical toxicology and drug development to enable you to develop new drugs faster and more efficiently.

Course Director:Dr. Shayne C. Gad, Principal of Gad Consulting Services

Tuition:Early Registration (SAVE $200): U.S. $2155 ($2055 with Group Rate*) (Must register and pay by July 21, 2008)

Regular Registration: U.S. $2355 ($2255 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement(CfPA) is accredited by the AccreditationCouncil for Pharmacy Education as a providerof continuing pharmacy education. Continuing

Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially allthe formal sessions and submission of a course evaluation.The CEU rate is 0.1 CEU per contact hour; statement ofcredit will be mailed within six weeks. You will have anopportunity to evaluate your successful completion of these course objectives through a Learning Assessment.This offering is Program# 716-000-08-072-L04

This course (#07-1807) has beenapproved for 3.0

Certification Maintenance Points by The American Boardof Industrial Hygiene (ABIH) for recertification

This course meets Board of Certified Safety Professionals(BCSP) criteria for points toward the Continuance ofCertification requirements.

(Please refer to page 21 for full description of each Accreditation)

Microencapsulation and Particle Coating ID: 774 Offering #: 0808-302

August 11–13, 2008 • Northbrook, ILWho Should Attend: The course should be of value to those working in microencapsulation, as well as to those in industry and research laboratories who would profit from a thorough presentation anddiscussion of the many techniques and the characteristics of the microcapsules formed from them. It should be of particular interest to personnel in the following industries:

• Pharmaceutical • Cosmetic • Bioengineering

• Food • Chemical • Agricultural

Course Summary: This program will provide an up-to-date assessment of available encapsulation techniques. Each lecturer will present the basic chemical and physical principles of their processes, as well as a discussion of specific techniques and applications. The aim of the program is to provide an understanding of the unique advantages and difficulties of each major microencapsulation technique.Emphasis will be placed on proven techniques, results and actual applications in various industries. The instructors, all of whom are recognized experts in their areas, will present the latest available information regarding the processes in which they specialize. The lectures are structured to encourageopen discussions between lecturers and participants.

Course Director:Dr. James D. Oxley, Senior Research Scientist, Department of Microencapsulation,Nanomaterials, and Process Engineering, Southwest Research Institute

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*) (Must register and pay by June 16, 2008)

Regular Registration: U.S. $1940 ($1860 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONS

The Center for ProfessionalAdvancement (CfPA) offersmany courses which have

a chemical component. Such courses may earn up to 20 Certification Units toward certification by The NationalCertification Commission in Chemistry and ChemicalEngineering, sponsored by The American Institute ofChemists.

This course (#07-1805)has been approved for 3.0 Certification

Maintenance Points by The American Board of IndustrialHygiene (ABIH) for recertification

(Please refer to page 21 for full description of each Accreditation)

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Page 15: Accredited Technical Training for the … July-Sept PH catalog.pdfAccredited Technical Training for the Pharmaceutical, Cosmetic, Food and Medical Device Industries Course Catalog

13For course information, go to www.cfpa.com

Please note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

Patent Law for Managers, Engineers & Scientists ID: 520 Offering #: 0808-307

August 14–15, 2008 • New Brunswick, NJWho Should Attend: This course would be profitable to those who are interested in the nature andextent of patent rights, how they are acquired, and how they may and may not be used. This includes,but is not limited to:

• Inventors• Engineers• Managers in industry, government and educational institutions

Course Summary: The U.S. Court of Appeals for the Federal Circuit is the focal point for the legal criteria by which US patents are enforced. The Court’s rulings on recent multi-million dollar patentinfringement awards illustrate how important it is for the business manager to understand how thepatent system works.

In addition, recent US Supreme Court decisions along with new USPTO rules will effect how to approach protecting intellectual property.

With the great increase in the cost of technology development, and the rapidity of technical progress in global markets, protection of intellectual property on a worldwide basis is becoming of critical importance. This course will provide inventors, and those who manage inventors, with a working knowledge of the U.S. and international procedures for the protection of intellectual property by patents. Emphasis will be placed on understanding the extent and limits of protection afforded by the patent laws, the U.S. re-examination procedure, the ways in which inventors can assist in obtaining patent protection, and the use of patents as a company asset. The relationship between patents and trade secrets, copyrights and trademarks will also be discussed. Instruction will include an explanation of problem areas in obtaining and maintaining patent rights. Correcting common misconceptions about patent systems and pointing out recent changes in the patent laws will also be emphasized.

Course Co-Directors:Burton A. Amernick, Partner, Law Firm of Connolly, Bove, Lodge & HutzT. Gene Dillahunty, Executive Vice President, Earth Renew, Inc.

Tuition:Early Registration (SAVE $200): U.S. $1275 ($1215 with Group Rate*) (Must register and pay by June 19, 2008)

Regular Registration: U.S. $1475 ($1415 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONS

(Please refer to page 21 for full description of each Accreditation)

Pharmaceutical Process Development ID: 1358 Offering #: 0807-501

July 28–30, 2008 • New Bunswick, NJWho Should Attend: TThis course is intended for personnel in process development, technical serviceand pilot plant groups within the pharmaceutical industry. This includes personnel responsible for manufac-turing of dosage forms for clinical studies. It will also be of value to personnel in

• Research & Development • Analytical Services• Product Development • Manufacturing• Production • Quality Assurance• Regulatory Affairs • CMC Projects

Course Summary: This three-day course is designed to provide a basic understanding of the significantprocess development effort involved in taking an R&D laboratory formulation to commercial production.This course will focus on two main areas:

1. How to develop a pilot process suitable for scale-up to commercial production.

2. Factors to consider during scale-up and technology transfer to take a product from formulation develop-ment to the production floor.

The course will review topics such as process flow and equipment selection. Regulatory considerations,such as documentation and a need for pilot scale products to be representative of commercial production,will be discussed.

Various technologies available for manufacturing dosage forms will be reviewed in the context of scale-upparameters. These will include processing methods for mixing, granulation, compression and coating ofsolid dosage forms, as well as processing methods for solutions, emulsions, suspensions and sterile par-enteral products.

Course Director:Mukund (Mike) Yelvigi, Director, CMC Development Planning, Wyeth Research Laboratories

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*) (Must register and pay by June 2, 2008)

Regular Registration: U.S. $1940 ($1860 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement(CfPA) is accredited by the AccreditationCouncil for Pharmacy Education as a providerof continuing pharmacy education. Continuing

Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially allthe formal sessions and submission of a course evaluation.The CEU rate is 0.1 CEU per contact hour; statement ofcredit will be mailed within six weeks. You will have anopportunity to evaluate your successful completion of these course objectives through a Learning Assessment.This offering is Program# 716-000-07-175-L04

(Please refer to page 21 for full description of each Accreditation)

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14 For course information, go to www.cfpa.com

Please note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

Pneumatic Conveying for Bulk Solids ID: 727 Offering #: 0807-305

July 14–16, 2008 • New Brunswick, NJWho Should Attend: This course is intended for professionals in the dry chemicals, cement, plastics,mining, food and pharmaceuticals industries and others where the handling of dry powder or granularmaterial is required. It will benefit:• Staff engineers involved in pneumatic conveying projects• Industrial engineers required to evaluate cost-cutting purchasing engineers working with vendors• Operating or maintenance personnel responsible for plant equipment

Course Summary: Pneumatic conveying has been a rapidly expanding area of materials handlingbecause of its cleanliness, flexibility, and the rapid payout possible as it replaces an older method.However, little information on the subject is available to the staff engineer; little or no coverage is provided in undergraduate curricula. Hence, the need for a course of this kind, where principles and practices are discussed in an atmosphere emphasizing practical application.

This course will provide: a thorough review of all systems in use; practical exercises in system designand equipment application; analysis of the working principles, operation and maintenance of individualpieces of pneumatic conveying hardware; and a description and explanation of methods used to minimize particle degradation and erosion from abrasive materials.

The session on troubleshooting is designed to give operating personnel sufficient practical under-standing of the operation of pneumatic conveying systems to make intelligent evaluations of their systems and to know what modifications can be made to improve operation at a minimum expense to the company.

Course Director:Paul E. Solt, Pneumatic Conveying Consultant

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*) (Must register and pay by May 19, 2008)

Regular Registration: U.S. $1940 ($1860 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONS

(Please refer to page 21 for full description of each Accreditation)

Pharmaceutical Quality Assurance and Control ID: 224 Offering #: 0809-405

September 22–26, 2008 • New Brunswick, NJWho Should Attend: This course will benefit those who need to know how quality can be assured andcontrolled in the production of pharmaceuticals and related products. The material is particularly suitablefor chemists, pharmacists, engineers and administrators working in the following areas:• R&D • Purchasing • Engineering • QC •Maintenance• Regulatory Affairs • Corporate/Plant Management • Plant Operations • QA

The course will also benefit personnel in Regulatory Agencies and Suppliers to the Industry.

Course Summary: This course provides an understanding of the principles and practice of pharmaceuti-cal quality assurance and control and of specific topics which have become important because of regulatory interest or recent technological achievements. Throughout the course an emphasis is placedupon quality as viewed on a cost/benefit basis as well as a cGMP basis.

The first day provides an understanding of the basic principles and practice of the QA and QC functions,covering their role during product design, production and revision, with the role in production being dealtwith in particular detail. The second, third and fourth days consist of reviews, first of broad current qualityissues including FDA activities, and then the QA/QC aspects of a number of specific issues including:handling of laboratory controls, validation (equipment, processes, computers, cleaning and test methods),label and labeling, water systems, change control, electronic records and signatures, deviations and discrepancies, (including OOSs), FDA inspections, internal and supplier audits, vendor and contract supplier qualification, annual product reviews, and training. A general question and answer session is also provided. The fifth day is devoted to the QA/QC aspects of stability program operation and also to documentation. The course includes hands-on workshops as well as lectures.

Course Director:Dr. Alan J. Smith, Pharmaceutical Quality and Technology Consultant

Tuition:Early Registration (SAVE $200): U.S. $2350 ($2245 with Group Rate*) (Must register and pay by July 28, 2008)

Regular Registration: U.S. $2550 ($2445 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement(CfPA) is accredited by the AccreditationCouncil for Pharmacy Education as a providerof continuing pharmacy education. Continuing

Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially allthe formal sessions and submission of a course evaluation.The CEU rate is 0.1 CEU per contact hour; statement ofcredit will be mailed within six weeks. You will have anopportunity to evaluate your successful completion of these course objectives through a Learning Assessment.This offering is Program# 716-000-08-144-L04

ISPE’s professional developmentcommittee approved CfPA’s courseswhich meet standards for professionaldevelopment.

(Please refer to page 21 for full description of each Accreditation)

The Center for ProfessionalAdvancement (CfPA) offersmany courses which have a

chemical component. Such courses may earn up to 20Certification Units toward certification by The NationalCertification Commission in Chemistry and ChemicalEngineering, sponsored by The American Institute ofChemists.

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15For course information, go to www.cfpa.com

Please note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

Process Analytical Technology (PAT) ID: 2085 Offering #: 0807-402

July 22–24, 2008 • New Bunswick, NJWho Should Attend: This comprehensive PAT workshop will benefit professionals who are involved inthe development, testing and production of pharmaceutical, OTC, fermentation and biopharmaceuticalproducts, including:• PAT Team Leaders • Industrial Pharmacists • Instrument makers• Pharmaceutical QA Personnel • Analytical Managers • Formulators • Manufacturing Operations Personnel • Dosage • Excipient suppliers• Managers tasked with improving the pharmaceutical business climate

Course Summary: Both the US Food and Drug Administration and the European Medicines Agency are pushing improvements in pharmaceutical manufacturing efficiency, defined as Process AnalyticalTechnology, or PAT. These initiatives are driven by increased regulatory demand, consumer pressure andsoaring drug dosage costs. The regulatory agencies have identified the test-to-document requirements ofthe old cGMP mandates as root causes for poor efficiency.

This course establishes a baseline view of pharmaceutical manufacturing and examines PAT from industri-al, regulatory and consumer viewpoints. Using case studies, the program demonstrates strategies thathelp management acceptance and support of PAT programs and provides tactics to avoid pitfalls.

Detailed guidelines for PAT Team formation and management include a five-step plan with milestones. PAT laboratory and testing workflow, with reference to in-process monitoring will help participants transitfrom theory to practice. Several instrument and sensor segments help form a PAT toolbox, as does areview of chemometrics and statistical analysis. These segments are followed by a PAT validation unit.

At the conclusion of the course, all participants will have a solid grounding in PAT program implementation.

Course Director:John E. Carroll, C.Ph.C., President, Carroll Ventures, Inc., Managing Partner, Cadrai LLC.

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*) (Must register and pay by May 27, 2008)

Regular Registration: U.S. $1940 ($1860 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement(CfPA) is accredited by the AccreditationCouncil for Pharmacy Education as a providerof continuing pharmacy education. Continuing

Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially allthe formal sessions and submission of a course evaluation.The CEU rate is 0.1 CEU per contact hour; statement ofcredit will be mailed within six weeks. You will have anopportunity to evaluate your successful completion of these course objectives through a Learning Assessment.This offering is Program# 716-000-06-431-L04

(Please refer to page 21 for full description of each Accreditation)

Preparing for and Surviving an FDA Inspection ID: 187 Offering #: 0808-306

August 12–13, 2008 • New Brunswick, NJWho Should Attend: This overview course is intended for individuals whose functions have direct orindirect involvement with FDA inspections. These functions include among others.

• Regulatory Affairs • Documentation Management • Quality Assurance • Plant Management • Executive Management • Auditing • Quality Control • Research and Development • Engineering

Course Summary: This course provides a background and understanding of the role played by theAgency, it’s administrative and enforcement powers. It takes the participant step by step through theentire inspection process and describes various types of inspections, i.e. pre-approval inspections (PAI),routine GMP inspections, bioresearch monitoring inspections, quality systems inspections techniques(QSIT) applied to device companies and system-based inspections program applied to drug companies. A detailed description of the six systems will be provided.

The course offers methodologies and techniques on:• How a firm should prepare for an FDA inspection • Ways to train employees in view of the inspection• How to interact with the investigator—DO’s and DON’T’s • How to reply to 483’s and warning letters • Legal implications of non-compliance • Post inspection actions • How to ensure that required docu-mentation is in place • What companies should do when the inspection endsThe course consists of lectures, discussions, and a practical workshop which will enable participants towork in small groups and design a company policy/procedure for handling FDA inspections.

Course Director:Renée B. Galkin, Quality Management Consultant

Tuition:Early Registration (SAVE $200): U.S. $1275 ($1215 with Group Rate*) (Must register and pay by June 17, 2008)Regular Registration: U.S. $1475 ($1415 with Group Rate*)

Attend this course and it’s companion course cGMP Auditing- Strategies for Compliance (ID# 2012) and save $300†. See page 4 for course description. †Discount applies only to combined regular tuition.

ACCREDITATIONS/CERTIFICATIONS

The Center for Professional Advancement(CfPA) is accredited by the AccreditationCouncil for Pharmacy Education as a providerof continuing pharmacy education. Continuing

Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially all the formal sessions and submission of a course evaluation. The CEU rate is 0.1 CEU per contact hour; statement of credit will be mailed within six weeks. You will have an oppor-tunity to evaluate your successful completion of these courseobjectives through a Learning Assessment. This offering isProgram# 716-000-08-300-L04

(Please refer to page 21 for full description of each Accreditation)

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16 For course information, go to www.cfpa.com

Please note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

REACH: Registration, Evaluation and Authorization of Chemicals ID: 2145 Offering #: 0809-205

September 10–12, 2008 • New Brunswick, NJWho Should Attend: This course offers a comprehensive review of the most recent European harmonizedchemical policy. It is designed for professionals involved in all aspects of chemical applications for a widerange of product development, including:• Research & Development • Technology, Formulation & Product Development• Marketing & Technical Sales • Business Decision Makers• QA & QC Professionals • Regulatory AffairsThis course would also benefit producers, manufacturers, processors and users within the chemical andcosmetic industry.

Course Summary: This course will provide an in depth overview of the REACH chemical program for professionals involved in chemical applications for all aspects of product development with business inter-ests in the European Union. It will also provide a side by side comparison and contrast of REACH and its variousinternational chemical regulation counterparts in other major world markets. Particular attention will be given to the basic regulatory components of REACH, regulatory authorities, the implementation infrastructure and initial schedules forcompliance. Finally, small group discussion/workshops will be conducted throughout the course to familiarize the participants with the impact of REACH concerning the chemical industry (manufacturers and users alike) in terms of the potential enforcement outcomes, the socio-economic cost, and the possible evolution of the best industrial practice for compliance.

Course Director:Wen Schroeder, President, SEKI Cosmeticals, LLC

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*) (Must register and pay by July 16, 2008)

Regular Registration: U.S. $1940 ($1860 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONS

(Please refer to page 21 for full description of each Accreditation)

July 28–30, 2008 • New Brunswick, NJWho Should Attend: This program is prepared for personnel in pharmaceuticals, medical devices, personal care products, cosmetics, toiletries, and the veterinary medicines industries. It will benefit those employed in packaging in:

• Development • Technology • Project Leading • Engineering• QA/QC • Auditing • Outsourcing • Regulatory Affairs• Purchasing • Marketing • Processing • Suppliers

Course Summary: This course provides a structured approach to validation practices, to ensure the packaging of a drug, medical device or allied product, conforms to its predetermined specification. Targets are: consistent quality to the consumer, compliance with regulatory requirements, safety, costeffectiveness, long term financial and other benefits to the company.

The need to translate customer/user requirements to measurable specifications, followed by controlledprocessing is explained. Emphasis is on practical ways of implementing validation, using protocols, SOP’s,planning, statistics, process controls and other tools. The Validation-Master Plan/Protocol, protocols, templates for IQ, OQ and PQ, and change controls are all detailed with text.

The course covers the essentials of validation and gives details of validating; a push-through-pack machine,packaging line, cleaning and sterile pack integrity.

Specific tasks and requirements of the various functional groups involved are covered in depth.Regulations are given special attention and prospective, concurrent and retrospective validation will be discussed critically. Vendor/supplier assessment and auditing are crucial and will be outlined.

Exercises in small groups and discussions will offer participants practice to develop skills to prevent or eliminate faults, failures and rejects in processing.

Course Director:Mervyn J. Frederick, Former Head of the Packaging Development Group, N.V. Organon, AKZO-Nobel

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*) (Must register and pay by June 2, 2008)

Regular Registration: U.S. $1940 ($1860 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement (CfPA)is accredited by the Accreditation Council forPharmacy Education as a provider of continuingpharmacy education. Continuing Education Units

(CEU) will be awarded only upon successful completion of thecourse, i.e., attendance at essentially all the formal sessions andsubmission of a course evaluation. The CEU rate is 0.1 CEU percontact hour; statement of credit will be mailed within six weeks.You will have an opportunity to evaluate your successfulcompletion of these course objectives through a LearningAssessment. This offering is Program# 716-000-08-308-L04

(Please refer to page 21 for full description of each Accreditation)

Process Validation for Packaging of Pharmaceuticals and Medical Devices ID: 1789 Offering #: 0807-502

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17For course information, go to www.cfpa.com

Please note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

Regulatory Compliance for the Personal Care Products Industry ID: 1522 Offering #: 0807-403

July 21–23, 2008 • New Brunswick, NJWho Should Attend: This course is intended for all those involved in the regulatory aspects of cosmetics, OTC drugs and personal care products and is especially beneficial to:

• Research and product • Research scientistsdevelopment personnel • Cosmetic chemists

• QC and QA professionals • Marketing personnelOperational, legal and management professionals who are commencing their careers in regulatoryaffairs or product compliance will likewise find this course extremely valuable.

Course Summary: This course will provide an in-depth overview of the regulatory requirements forpersonal care products in the United States and the European Union and will highlight their similari-ties and differences. It is designed to address the questions of regulatory compliance detailing thecurrent regulations and enforcement tools that control the marketing and promotion of cosmeticsand OTC personal care drugs. This will include a detailed discussion of the various regulatory agencies and will review their authority and programs that directly or indirectly affect the personalcare industry.

Particular attention will be given to labeling, claims, colors and other ingredient restrictions,inspections and Federal enforcement.

Course Director:James Akerson, Consultant to the Cosmetic and Drug Industries

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*) (Must register and pay by May 26, 2008)

Regular Registration: U.S. $1940 ($1860 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONS

The Center for Professional Advancement (CfPA)is accredited by the Accreditation Council forPharmacy Education as a provider of continuingpharmacy education. Continuing Education Units

(CEU) will be awarded only upon successful completion of thecourse, i.e., attendance at essentially all the formal sessions andsubmission of a course evaluation. The CEU rate is 0.1 CEU percontact hour; statement of credit will be mailed within six weeks.You will have an opportunity to evaluate your successfulcompletion of these course objectives through a LearningAssessment. This offering is Program# 716-000-06-039-L04

(Please refer to page 21 for full description of each Accreditation)

Sensory Evaluation ID: 434 Offering #: 0809-402

September 22–25, 2008 • New Brunswick, NJWho Should Attend: This course is for those who need to design and conduct sensory evaluation testswithin the consumer product industry. The course presents a general overview of sensory methods withconsideration given to method specifics including data analysis and interpretation. Those who have bene-fited from this course include:

• Food technologists • Cosmetics chemists • Sensory scientists• Technical and managerial personnel • Home economists • Product DevelopersLaboratory technicians who are responsible for sample preparation and presentation will also benefit from this course.

Course Summary: The enjoyment of food, as well as the acceptance of flavors in pharmaceutical andother products, is closely related to the senses, especially taste, aroma and texture. Sensory evaluation is a dynamic field concentrating on the utilizationof humans for the measurement of sensory perceptions and/or their effect on food and taste acceptance.

This course is designed to assist you as you select, conduct, analyze and interpret sensory evaluation methods. This approach will be practical with lecture,laboratory and problem-solving sessions. You will learn about sensory physiology, method selection, discriminative and descriptive testing, preference/acceptance testing and statistical analysis of data. An important feature of the course is the laboratory/ demonstration sessions in which you will participate.

Course Director:Gail Vance Civille, President, Sensory Spectrum, Inc.

Tuition:Early Registration (SAVE $200): U.S. $2355 ($2255 with Group Rate*) (Must register and pay by July 28, 2008)

Regular Registration: U.S. $2555 ($2455 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONS

(Please refer to page 21 for full description of each Accreditation)

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18 For course information, go to www.cfpa.com

Please note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

Skin Product Development ID: 1050 Offering #: 0808-501

August 25–27, 2008 • New Brunswick, NJWho Should Attend: The course is designed for individuals who are engaged in the personal care, cosmetic and pharmaceutical industries. It is intended for individuals who work both in the development of raw materials, delivery systems and finished formulations, including:

• Research and Development • Technical Sales • Formulations Development • Marketing

Course Summary: The design of topically applied formulation combines scientific knowledge in physics, chemistry, engineering and biochemistry and requires imagination and artistic skills.

Throughout the design, one must become familiar with the fundamentals of skin structure, itspharmacology and possible delivery approaches. The understanding of formulation’s physical properties,ways of measuring these properties are additional essential aspects to learn.

Becoming familiar with both, one can extrapolate the possible interactions between a topically appliedformulation and the skin as a viable organ. This can allow for optimization of development.

Over the past decade, both the pharmaceutical and cosmetic industries have gone through majorchanges that are mainly driven by consumer demand, aggressive market claims, regulatory issues and scientific breakthrough discoveries.

This course will provide participants with understanding the diversity of the above and will channel andfocus their development approaches. It will also provide knowledge in related terminology to createsales tools and marketing claims.

Course Director:Nava Dayan, Ph.D., Skin Care Research Expert

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*) (Must register and pay by June 30, 2008)

Regular Registration: U.S. $1940 ($1860 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement(CfPA) is accredited by the AccreditationCouncil for Pharmacy Education as a providerof continuing pharmacy education. Continuing

Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially all the formal sessions and submission of a course evaluation. The CEU rate is 0.1 CEU per contact hour; statement of credit will be mailed within six weeks. You will have an oppor-tunity to evaluate your successful completion of these courseobjectives through a Learning Assessment. This offering isProgram# 716-000-06-160-L04

The Center for ProfessionalAdvancement offers manycourses which have a

chemical component. Such courses may earn up to 20Certification Units toward certification by The NationalCertification Commission in Chemistry and ChemicalEngineering, sponsored by The American Institute ofChemists.

(Please refer to page 21 for full description of each Accreditation)

Siloxane Technology and Personal Care Applications ID: 2207 Offering #: 0807-309

July 14–15, 2008 • New Brunswick, NJWho Should Attend: The course should be of value to those working with cosmetic/toiletry productsfocusing on the potential use of Siloxane technology, as well as to those in industry and research laboratories interested in a basic understanding of the Siloxane technology and applications thereof.

The course is intended primarily for entry and mid level development technologists looking for thebroad understanding of functional Siloxane materials. The course should provide an up-to-date refresh-er for experienced individuals as well. Chemists, formulators and process engineers from the field ofcosmetics, toiletries, pharmaceuticals and bioengineering industries will benefit from the opportunity to understand more about the chemistry, synthesis and processes, formulations, and regulatory andsafety parameters for use in personal care.

Course Summary: This course is intended to provide a comprehensive review of the chemistry and physical fundamentals and performance of different types of functional Siloxanes. There will be significant emphasis on how Siloxane's unique chemistry influences the physical properties and howone can harness this uniqueness to formulate and develop functional products that match consumerneeds.

The instructors, both with many years of experience in this area, will present the latest available information, as well as trends regarding the field of Siloxanes. Though the course will be structured, there will be open discussion and opportunities for debate about specific problems and needs of participants.

Course Director:Eric S. Abrutyn, Senior Principal Scientist, Kao Brands Company

Tuition:Early Registration (SAVE $200): U.S. $1275 ($1215 with Group Rate*) (Must register and pay by May 19, 2008)

Regular Registration: U.S. $1475 ($1415 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONS

(Please refer to page 21 for full description of each Accreditation)

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REVISE D!

EXPANDED&

REVISE D!

Expand ed

REGIST EREARL Y & SAVE!

By XXXX XXth

FDAAlumniWith

The Center for ProfessionalAdvancement (CfPA) offers

many courses which have a chemical component. Suchcourses may earn up to 20 Certification Units towardcertification by The National Certification Commission inChemistry and Chemical Engineering, sponsored by The American Institute of Chemists.

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19For course information, go to www.cfpa.com

Please note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

September 16–18, 2008 • New Brunswick, NJWho Should Attend: This overview course is intended for those having specific responsibilities in theareas of sterile drug product science and technology. It will be of particular value to those in:

• Research• Production• Development• Quality Assurance and Control

Those who wish to broaden their appreciation of these technologies and review the latest developments,as well as managers who have responsibility for a broader base of activities will find the course of interest.

Course Summary: This comprehensive course provides an appreciation and general understanding of the overall contemporary state of science and technology associated with the design, development andmanufacturing of sterile drug dosage forms. Emphasis will be oriented toward formulation developmentand product manufacture of quality sterile dosage forms that meet or exceed expected good manufactur-ing practice requirements.

Course Director:Dr. Michael J. Akers, Senior Director of Pharmaceutical R&D , Baxter BioPharma Solutions

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*) (Must register and pay by July 22, 2008)

Regular Registration: U.S. $1940 ($1860 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement(CfPA) is accredited by the AccreditationCouncil for Pharmacy Education as a providerof continuing pharmacy education. Continuing

Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially allthe formal sessions and submission of a course evaluation.The CEU rate is 0.1 CEU per contact hour; statement ofcredit will be mailed within six weeks. You will have anopportunity to evaluate your successful completion of thesecourse objectives through a Learning Assessment.This offering is Program# 716-000-08-165-L04

(Please refer to page 21 for full description of each Accreditation)

Sterile Products: Formulation, Manufacture and Quality Assurance ID: 435 Offering #: 0809-305

Sunscreen Technology and Product Development ID: 2017 Offering #: 0807-308

July 16–18, 2008 • New Brunswick, NJWho Should Attend: This course is designed for professionals in the personal care, cosmetic and pharmaceutical industries engaged in sunscreen product development, including:• Research & Development • Technology, Formulation & Product Development• Marketing & Technical Sales • Regulatory Affairs• Business Decision Makers • QA & QC Professionals

Course Summary: To formulate a successful sunscreen product for topical application requires a multidisciplinary approach. Factors need to be taken into consideration include the current market trends& demands, regulatory framework & compliance requirements, scientific learning on skin structure andfunction, UV-interacting chemistry & science, and appropriate delivery systems for optimal effectivenessand safety. This course will provide an overview of sunscreen regulations and technologies that enablethe participants to design proper strategies for successful product development and marketing. In addi-tion, small group discussion / workshops on real-life case studies will be conducted throughout thecourse to familiarize the participants with the complex regulatory framework and product labeling & advertising guidelines.

Course Director:Wen Schroeder, President, SEKI Cosmeticals, LLC

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*) (Must register and pay by May 21, 2008)

Regular Registration: U.S. $1940 ($1860 with Group Rate*)

ACCREDITATIONS/CERTIFICATIONSThe Center for ProfessionalAdvancement (CfPA) offersmany courses which have a

chemical component. Such courses may earn up to 20Certification Units toward certification by The NationalCertification commission in Chemistry and ChemicalEngineering, sponsored by The American Institute ofChemists.

(Please refer to page 21 for full description of each Accreditation)

This course (#07-1803)has been approved for 3.0 Certification Maintenance Pointsby The American Board of Industrial Hygiene (ABIH) forrecertification.

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20 For course information, go to www.cfpa.com

Please note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

September 15–17, 2008 • New Brunswick, NJWho Should Attend: This course is intended for personnel needing a quick, yet comprehensive, survey of tablet production. Those who have gained valuable information from this course include:

• Senior Process • Newly PromotedOperators Supervisors

• QA Personnel • Warehouse Personnel• Packaging Personnel • Regulatory Affairs Specialists

This course is not intended for higher level technical and senior managerial personnel, for whom other related courses are available.

Course Summary: This course provides an orientation and understanding of bulk tablet production for process operators and first-line supervisors. The course begins with the basic aspects of tablet formulating and the unit operations necessary to produce production quantities. All aspects of granulating, compressing, coating, printing, cleaning and documenting will be covered. The application of cGMP, as applied to tableting operations, will also be presented.Important supporting operations such as tool and die maintenance, tablet inspection, basic validationprinciples, sanitation fundamentals, proper materials weighing techniques and equipment automation willbe presented.The course includes two workshops and discussion periods between faculty and course participants. Problem-solving sessions are held on both an open and private basis.

Course Director:Fred A. Rowley, Director, Watson Pharmaceuticals

Tuition:Early Registration (SAVE $200): U.S. $1740 ($1660 with Group Rate*) (Must register and pay by July 21, 2008)

Regular Registration: U.S. $1940 ($1860 with Group Rate*)

Tablet Production for Operators and Supervisors ID: 1428 Offering #: 0809-304

ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement(CfPA) is accredited by the AccreditationCouncil for Pharmacy Education as a providerof continuing pharmacy education. Continuing

Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially all the formal sessions and submission of a course evaluation. The CEU rate is 0.1 CEU per contact hour; statement of credit will be mailed within six weeks. You will have an oppor-tunity to evaluate your successful completion of these courseobjectives through a Learning Assessment. This offering isProgram# 716-000-07-167-L04

(Please refer to page 21 for full description of each Accreditation)

IntroducingOnline TrainingA new way to experience CfPA’s Accredited Technical Training!

CfPA’s Online Training is a perfect complement to our public and clientsite programs. Experience the ability to supplement your training needs or expand on your knowledge in areas critical to your job function.Available live and on-demand.

Advantages of CfPA’s Online Training:Convenient – Access CfPA Online Training from your office, home

or on the road - anywhere around the world

Interactive – Actively participate with instructor and participants in a virtual classroom through the use of polls, Q&A and other online tools

Topics – All courses taught by leading industry experts, topicareas are similar to our public courses and includebasic concepts to the latest advances

Accredited – Training programs are accredited and/or certified

Easy to Use – All you need is a computer with an internet connection, and a phone line

Cost Effective – Save on travel costs and time out of the office

On-Demand – Previously held courses are available for viewing when it is convenient for you

For more information on our Online Training:Go to www.cfpa.com/online-training or E-mail [email protected]

Customized Training ThroughClient Site ProgramsWhatever your on-site needs may be, we can meet them.

Offered at your location and at your convenience, CfPA will bringany course to your team for customized training, or we can workwith you to develop a program to address the specific issues mostcritical to you.

What are the advantages to a Client Site Course?

• You can have up to thirty-five of your engineers, scientists andtechnical managers participating simultaneously in a course.

• You have the opportunity to tailor the standard program to your company’s specific problems and interests.

• You have one-to-one access with a top teaching teamspecializing in your industry, and comprehensive coursematerial, for an all-inclusive fee.

• You save on costly hotel and travel expenses.

How to arrange a Client Site Course:If your company is interested in a Client Site training program,please contact our Client Site division at 732.238.1600 ext. 4549 or E-mail [email protected].

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21For course information, go to www.cfpa.comID: 2138 - Offering: 0803-802 - BID: C8-078

Please note course topics, dates, and locations subject to change. Please refer to our website for the most current information.

Accreditations/Certifications

The Center for Professional Advancementhas been reviewed and approved as an AuthorizedProvider (#640) of continuing education and trainingprograms by the International Association forContinuing Education and Training (IACET).Continuing Education Units (CEU) will be awarded

for participation in the courses noted in this catalog at a rate of 0.1 CEU per contact hour. CEU will be awarded only uponsuccessful completion of the course, i.e., attendance at essentially all the formal sessions and submission of a course evaluation.

ASQ Certification: ASQ Certified Quality Engineers, ReliabilityEngineers and Quality Auditors may earn recertification creditsfor attending certain programs within this catalog providing it iscovered under one area of the body of knowledge in whichthey are seeking recertification or is job enhancement.

The Center for Professional Advancement(CfPA) offers many courses which have achemical component. Such courses may earnup to 20 Certification Units toward certification

by The National Certification commission in Chemistry and ChemicalEngineering, sponsored by The American Institute of Chemists.

CfPA is a program sponsor approved by the Pennsylvania Board ofAccountancy #PX-002022-L. This course has been approved for thesepurposes.

ISPE’s professional development committeeapproved CfPA’s courses which meet standards forprofessional development.

BCSP – This course meets Board of Certified Safety Professionals(BCSP) criteria for points toward the Continuance of Certificationrequirements

Locations

Certain courses in this catalog have been approved forrecertification credits by the AACE International CertificationBoard toward meeting the continuing education requirements for recertification as a Certified Cost Engineer, Certified CostConsultant, Planning and Scheduling Professional and EarnedValue Professional.

The Center for Professional Advancement (CfPA) is accredited by the Accreditation Council for Pharmacy Education as aprovider of continuing pharmacy education. Continuing EducationUnits (CEU) will be awarded only upon successful completion of

the course, i.e., attendance at essentially all the formal sessions and submissionof a course evaluation. The CEU rate is 0.1 CEU per contact hour; statement ofcredit will be mailed within six weeks. You will have an opportunity to evaluateyour successful completion of these course objectives through a LearningAssessment. (See specific course for details)

SME Certified Manufacturing Engineers (CMfgE) and Technologists (CMfgT) may earn recertificationcredits. (See specific course for details) Certification isvaluable to everyone in industry. It is a recognized

method of maintaining knowledge and skills in your field. For complete detailson SME Certification, contact Diane Wrobel, Coordinator, SME, ManufacturingEngineering Certification Institute, One SME Drive, Dearborn, MI 48121,313.271.1500, ext. 516.

ABIH Certification:Certain courses have been approved for Certification Maintenance Points by

The American Board of Industrial Hygiene (ABIH) for recertification. (See specific course for details)

The American Association of Family and Consumer Scienceshas approved the designated courses for ProfessionalDevelopment Units.

A limited block of rooms in the hotel will be held for our registrants until four weeks before the course. Participants must, however, make their own reservations; the cost of hotel accommodation is not included in the course fee.

To receive CfPA's rate and room block, be sure to mention that you will be attending one of our courses.

CfPA holds 13 Accreditations. The following are available for the selected courses in this catalog. For more informationon all of our Accreditations/Certifications visit our website at www.cfpa.com.

CfPA courses on pages 1-20 are held in the following hotels. Please refer to individual course on our website for appropriate location.

Terms and ConditionsDiscounts/Rates: Early registration discount requires payment at time of registration and before expiration or regular tuition will apply.

*Group Rate is for two or more enrollments registering at the same time, from the same company, for the same course. Multiple discounts not applicable.

Cancellations/Substitutions: All cancellations are subject to a $150.00 processing fee. Applicants may cancel up to two weeks prior to the course start date for a refund. If less than two weeks, a credit will be issued that can be used towards a future course up to one year from the date of issuance. No refunds or credit will be issued for those who do not attend the scheduled course and/or cancel less than two working days before the start date. Substitutions are permitted at any time. If for any reason, CfPA decides to cancel this course, we are not responsible for airfare, hotel or other costs incurred by the registrant. Program content, schedule and instructors are subject to change without notice.

Confirmation Letters: Before each course begins, all registrants will receive written confirmation including detailed information regarding course location. If confirmation is not received two weeks prior to the course please contact us.

For our full terms and conditions, visit www.cfpa.com.

General Information

Burlingame, California:DoubleTree Hotel (SF Airport)835 Airport BlvdBurlingame, CA 94010Phone: 650-344-5500

Embassy Suites SF Airport150 Anza Blvd,Burlingame, CA, 94010 Phone: 650-342-4600

Northbrook, Illinois:Hilton Northbrook2855 N Milwaukee AveNorthbrook, IL 60062Phone: 847-480-7500

New Brunswick, NewJersey:Hyatt Regency2 Albany StreetNew Brunswick, NJ 08901Phone: 732-873-1234

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Accredited Technical Training for the Pharmaceutical Cosmetic, Food and Medical Device Industries

www.cfpa.com

Limited

Seats Available.

Register Today!

July – September 2008 U.S. Course OfferingsCourse Topics in this Catalog Include:Excipient GMPs, Globally Harmonized Systems (GHS);ICH Q10: Pharmaceutical Quality System; ISO 13485, ISO 9001and QSR Regulations for Medical Device Companies; Process Analytical Technology (PAT); REACH: Registration,Evaluation and Authorization of Chemicals; Siloxane Technology& Personal Care Applications

PLEASE USE THE ABOVE PRIORITYCODE WHEN REGISTERING

PRST STDU.S. POSTAGE

PAIDTHE CENTER FORPROFESSIONALADVANCEMENT

RegistrationName Title

Company

Address

City State/Province Zip Code

Phone Fax E-mail

Check: Payable in US funds to: The Center for Professional Advancement

Credit Card: Visa Mastercard American Express Discover Card #: _______________________________ Exp. Date: _________

Cardholder Name: _________________________________________ Signature: ___________________________________________

Instructions:Please complete Registrant Information, Course Information andPayment Sections. Submit one form per individual registrant.

Check here if group discount applies (two or more enroll-ments for the same course, from the same company).

ONLINE: www.cfpa.com PHONE: FAX: MAIL:(Please Use Priority Code Below) 732-613-4500 732-238-9113

The Center for Professional Advancement (CfPA)P.O. Box 7077, East Brunswick, NJ 08816-7077

Payment

Course Title: 1) Course ID# Tuition

2)

3)

Total $