OCTOBER 10-11, 2013 5th Annual … · pharmaceutical & medical device manufacturing & quality assurance forum ... 9:15 genentech case study: ... pharmaceutical & medical device manufacturing

PHARMACEUTICAL & MEDICAL DEVICE MANUFACTURING & QUALITY ASSURANCE FORUM

SAN ANTONIO, TXOCTOBER 10-11, 2013

5th Annual

Optimizing Manufacturing Operations throughout the Life Science Industry through Establishing a Comprehensive Understanding of Change Control Management, Technology Transfer Methodologies and

Maintenance of Quality Compliance Regulatory Requirements

500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com

DISTINGUISHED PRESENTERS INCLUDE:Robert WoodVP World Wide ManufacturingVARIAN MEDICAL SYSTEMS

James TillmanVice President, Quality and Regulatory Compliance InitiativesDANAHER CORPORATION

TJ DotsonDirector, Quality AssuranceGE HEALTHCARE

Jaspreet GillVP Global Quality & Compliance, Corporate QualityBAXTER HEALTHCARE

Tina Stiles Associate Director, Corporate QA TrainingMILLENNIUM PHARMACEUTICALS

Melissa SeymourSenior Director, Corporate GxP Compliance and Quality SystemsBIOGEN IDEC

Kent PruettDirector Quality Assurance & Regulatory AffairsFUJIREBIO DIAGNOSTICS

Chris BalducciTechnical Research & Development Network LeaderNOVARTIS

Claudia LombardoOperational Excellence PrincipalGENENTECH

Mick RakauskasPrincipal Human Factors EngineerBAXTER HEALTHCARE

Darren DasburgVP Capacity UtilizationMEDIMMUNE

David AmorCOOREMIND TECHNOLOGIES

Timothy ReinhardtTeam Leader, Manufacturing & Supplier AssessmentsPFIZER

Prasad GogineniAssociate Director, Pharmaceutical TechnologyACTAVIS

Robert BergerDirector, Contract ManufacturingCOVIDIEN

Mohan PonnuduraiIndustry Solution DirectorSPARTA SYSTEMS

Edwin Harmon IIIDirector of Manufacturing GENZYME

Frank JohnstonDirector, Medical & PAS Regulatory ComplianceBD

Brad C. HolstineVMSC - Sterile Liquids Commercialization MERCK

Robert ArnottSenior Director, Supplier QualityBAXTER HEALTHCARE

Mide KrajaOperational Excellence Manager GENENTECH

PRESENTING COMPANIES INCLUDE:

Kimberly ParisVP, Quality OperationsB.BRAUN MEDICAL

Elena MackDirector, Quality Assurance & RegulatoryORASURE

Pat BairdTechnical DirectorBAXTER HEALTHCARE

Chris HoagAssociate Director, Corporate CAPA SystemsSTRYKER

Dave ChlebdaSenior Director, Regulatory OperationsTEVA PHARMACEUTICALS

Art CastronovoDirector, Labeling & Packaging EngineeringSMITHS MEDICAL

Ravi NabarSenior Director, Supplier Quality ManagementPHILIPS HEALTHCARE

Chad WesthovenAssociate Director, Quality & ComplianceGRIFOLS

Monica LentSenior Manager, Process Validation &Knowledge ManagementGENENTECH

Jill NeriChange Control ManagerGENZYME

Stephen BlaisSenior Manager, Contract ManufacturingSANTARUS PHARMACEUTICALS

DAY ONE / THURSDAY, OCTOBER 105TH ANNUAL PHARMACEUTICAL & MEDICAL DEVICE MANUFACTURING & QUALITY ASSURANCE FORUM


7:30 REGISTRATION & CONTINENTAL BREAKFAST

8:25 CHAIRPERSON’S OPENING REMARK

CROSS INDUSTRY SESSIONS8:30 KEYNOTE PANEL: IMPLEMENTING COST REDUCTION STRATEGIES WITHOUT REDUCING OVERALL QUALITY STANDARDS• Can cost management, quality management, and production management goals truly align?• Inventory and waste management considerations• Determine what cost-cutting measures have proved the most successful in recent yearsRobert Wood, VP World Wide Manufacturing, VARIAN MEDICAL SYSTEMSDarren Dasburg, VP Capacity Utilization, MEDIMMUNE *Pending Final ConfirmationKimberly Paris, VP, Quality Operations, B.BRAUN MEDICALFrank Johnston, Director, Medical & PAS Regulatory Compliance, BD

9:15 GENENTECH CASE STUDY: VARIABILITY REDUCTION STRATEGIES TO INCREASE END GAME THROUGHPUTClaudia Lombardo, Operational Excellence Principal, GENENTECHMide Kraja, Operational Excellence Manager, GENENTECH

10:00 COFFEE & NETWORKING BREAK

11:00 EVALUATING THE EFFECT OF DESIGN FOR MANUFACTURABILITY (DFM) PLANS ON MANUFACTURING AND QUALITY PROCESSESDesign for manufacturability (DFM) plans are a key component for any or-ganization when fabricating new product designs to avoid costly and time delaying re-designs. Open communication between designers and manu-facturing executives early in the product’s innovation stage allows design teams to build the product with a firm understanding of manufacturing capabilities and processes which can greatly decrease a product’s time to market. While DFM can be a timely analysis tool, manufacturing and quality executives recognize the process can stave off prospective design reprocessing delays while also increasing overall product quality. David Amor, COOREMIND TECHNOLOGIES

11:00 MULTI-THERAPUETIC PERSPECTIVE PANEL DISCUSSION: DEBATING THE COMPLEXITIES OF MANUFACTURING WITHIN TODAY’S EVER-EVOLVING ENVIRONMENT• Recognizing how the increasing intricacy of products and supply chains affects overall quality and manufacturing processes• Internal or External: Which manufacturing model is more effective in the current industry atmosphere• Continued globalizations influence on manufacturing & supplier decisionsDarren Dasburg, VP Capacity UtilizationMEDIMMUNE *Pending Final ConfirmationTimothy Reinhardt, Team Leader, Manufacturing & Supplier AssessmentsPFIZEREdwin Harmon III, Director of ManufacturingGENZYME

11:45 EXTERNAL MANUFACTURING: ESTABLISHING AND MAINTAINING PRODUCTIVE CMO PARTNERSHIPSHistorically, contract manufacturing was utilized as a mere cost-cutting measure for pharmaceutical organizations; however as the life science industry continues to grow external manufacturing relationships has be-come more strategic in nature. Organizations have begun to look at CMOs as a route to new innovate process and technology offerings. While cost is still a drive consideration in the establishment of CMO partnerships the sharing of new manufacturing processes and capabilities has added a new layer of differentiation that executives must take into account when choos-ing long-term external partners. • Establish the working tone and philosophy of the partnership• Cultivating clear communication channels and liaison support• Development of quality and timeline expectationsStephen Blais, Senior Manager, Contract ManufacturingSANTARUS PHARMACEUTICALS

12:30 NETWORKING BREAK & LUNCHEON FOR ALL PARTICIPANTS

11:45 UTILIZATION OF HUMAN FACTORS ENGINEERING (HFE) PRACTICES TO REDUCE POTENTIAL ADVERSE EVENTSHuman factors engineering is a means of ascertaining that a medical de-vice possesses an acceptable level of usability when released for use in real-world environments. As an important aspect of a product’s design control documentation, it is essential for executives to explore the benefits of utilizing HFE to provide evidentiary support that a product’s current de-sign maintains high compliance of safety and efficacy levels as a part of standard risk management practices. • Principles of human factor engineering methodology• Exploring HFE as a risk management tool rather than a usability evaluation• Gain understanding of FDA expectations and regulations of HFEPat Baird, Technical DirectorBAXTERMick Rakauskas, Principal Human Factors EngineerBAXTER

PHARMACEUTICAL TRACK

MEDICAL DEVICE TRACK

DAY ONE / THURSDAY, OCTOBER 105TH ANNUAL PHARMACEUTICAL & MEDICAL DEVICE MANUFACTURING & QUALITY ASSURANCE FORUM


MEDICAL DEVICE SESSIONS2:00 EXCHANGE GROUP DISCUSSION: APPLICATION OF UNIQUE DEVICE IDENTIFIER (UDI) PROCESSES TO ENSURE REGULATORY COMPLIANCEThe 2007 FDA Amendments Act gave the FDA the authority to establish a unique identifier system for the medical device industry and after years of pilot programs and draft regulations the FDA is expected to release its final UDI ruling in May 2013. The institution of the UDI program is expected to benefit the overall healthcare industry with reduced medical errors, rapid in-formation retrieval, and increased safety communication. Following the re-lease of the final ruling the UDI system will be implemented over a seven year period beginning with full compliance for Class III devices within one year.• Group Discussion One: Compliance and Regulatory ConsiderationsMohan PonnuduraiIndustry Solution DirectorSPARTA SYSTEMS• Group Discussion Two: Implementation Strategies

PHARMACEUTICAL SESSIONS2:00 SUPPLIER RISK MANAGEMENT: CREATION AND IMPLEMENTATION OF VENDOR ASSESSMENT MATRIXESDuring past testimony to the Senate HELP Committee, FDA Deputy Com-missioner Deborah Autor testified that the FDA believes that “additional statutory authority could place greater responsibility on manufacturers to account for the quality and provenance of the materials that go into their products.” The recent spotlight placed upon industry supplier quality auditing practices and the call to place increased accountability on phar-maceutical manufacturing organizations has pushed quality executives to re-evaluate and strengthen internal vendor qualification and assessment parameters. Strengthen those benchmarks allows organizations to ensure they possess a comprehensive knowledge regarding the origins of all mate-rials used to create their products.• Define assessment metrics and benchmarks• Reporting and evaluation processes• Auditing strategies for international suppliersRobert ArnottSenior Director, Supplier QualityBAXTER HEALTHCARE

2:45 OVERCOMING CHALLENGES ASSOCIATED WITH THE IMPLEMENTATION OF SINGLE-USE MANUFACTURING SYSTEMS• Debate the correlated limitations and hazards of single-use systems employment• Navigating the integration of single-use systems into current manufacturing facilities• Measuring the cost and quality benefits associated with single-use manufacturing systemsBrad C. HolstineVMSC - Sterile Liquids Commercialization MERCK

2:45 MEDICAL DEVICE PACKAGING INTEGRITY AND VALIDATION STRATEGIES• Verifying packaging stability through validation • Methodologies utilized to appraise package integrity• Balancing package design vs. environmental condition considerationsArt CastronovoDirector, Labeling & Packaging EngineeringSMITHS MEDICAL


4:30 EXECUTING STREAMLINED TECHNOLOGY TRANSFER THROUGHOUT PHARMACEUTICAL MANUFACTURING FACILITIESOrganizations can accrue a vast amount of knowledge and information during the development of a product’s design and any loss of data could be detrimental to the timely commercial release of a product. Comprehen-sive technology transfer processes are vital for the successful transition of product data from developmental and clinical departments over to com-mercial manufacturing facilities. Through the sharing of best practices and lessons learned this case study will highlight the cruciality of a cohesive and concise technology transfer practices to secure the knowledge regard-ing the efficacy, quality, and design of new products. Prasad GogineniAssociate Director, Pharmaceutical TechnologyACTAVIS


4:30 EXTERNAL MANUFACTURING: QUALIFICATION ANDEVALUATION CONSIDERATIONS FOR CMO PARTNERSHIPSMany medical device organizations, from clinical to large commercial stage, have made the decision to outsource certain product manufactur-ing responsibilities to 3rd party manufacturing organizations in order to re-duce overall production costs. The creation of CMO partnerships removes a large portion of production control away from manufacturing executives; although the device corporations are still the accountable party when qual-ity infractions are discovered. For this reason, manufacturing and quality executives need to have thorough and elaborate qualification benchmarks in place before finalizing CMO partnerships to ensure both organizations are compatible in regards to deadline and quality standards. • Creating measurable benchmarks to evaluate potential CMO partners• Establishing open communication network work CMOs• Outlining CMO expectations, standards, and deadlinesRobert Berger, Director, Contract ManufacturingCOVIDIEN

CROSS INDUSTRY SESSIONS5:20 PANEL DISCUSSION: OPERATIONAL AND REGULATORY CONSIDERATIONS FOR INTERNATIONAL MANUFACTURING Expanding manufacturing operations to international markets is a goal for any successful global organization but raises a plethora of logistical and regu-latory concerns for life science executives to overcome. Whether a company is opening new facilities or working with foreign contract manufacturers, executives must assess how each country’s regulatory standards will affect their manufacturing operations. • Regional regulatory considerations for EU, Asia-Pacific, and South American production• Developing international supply chain• Establishing distribution network• Outlining relationships with foreign CMOsRobert Wood, VP World Wide ManufacturingVARIAN MEDICAL SYSTEMSTimothy Reinhardt, Team Leader, Manufacturing & Supplier AssessmentsPFIZEREdwin Harmon III, Director of ManufacturingGENZYMEFrank Johnston, Director, Medical & PAS Regulatory ComplianceBD

6:05 NETWORKING MEETING & COCKTAIL RECEPTION FOR ALL FORUM PARTICIPANTS

7:05 CONCLUSION OF DAY ONE FORUM EVENTS

DAY TWO / FRIDAY, OCTOBER 115TH ANNUAL PHARMACEUTICAL & MEDICAL DEVICE MANUFACTURING & QUALITY ASSURANCE FORUM


7:30 CONTINENTAL BREAKFAST & NETWORKING OPPORTUNITY

7:55 CHAIRPERSON’S OPENING REMARK

CROSS INDUSTRY SESSION8:00 PANEL DISCUSSION: 483 INSPECTION OBSERVATION RESPONSE MANAGEMENT BEST PRACTICES• Discuss recent trends in reported 483 observations• Best approach strategies for close out meetings with FDA representatives• Lessons learned from past 483 issuances Jaspreet Gill, VP Global Quality & Compliance, Corporate Quality, BAXTER HEALTHCARE TJ Dotson, Director, Quality Assurance, GE HEALTHCAREMelissa Seymour, Senior Director, Corporate GxP Compliance and Quality Systems, BIOGEN IDECJames Tillman, Vice President, Quality and Regulatory Compliance Initiatives, DANAHER CORPORATION Elena Mack, Director, Quality Assurance & Regulatory, ORASURE

MEDICAL DEVICE SESSIONS8:50 INDUSTRY-MANAGED SPECIAL PROCESS SUPPLY CHAIN QUALITY OVERSIGHT PROGRAMAccording to an FDA Enforcement report in Q2 2012, 123.5 million units were affected by device recalls which was a 4% increase from the previ-ous year. The persistent rise in medical device product recalls continues to emphasize the dire need for increased comprehensive and methodical supplier risk monitoring practices. Globalization and the rise in material complexity are key influences compelling industry executives to enhance and expand current supplier monitoring practices to ensure continued product quality compliance. This session will:• describe this important supply chain quality program-in-development by key medical device OEM’s, suppliers and industry representatives work-ing in partnership with agencies and Performance Review Institute (a non-profit arm of the SAE)• explain the process for first-tier and sub-tier supplier oversight of spe-cial manufacturing processes affecting the quality of medical devices in a global supply chain environment• emphasize the benefits of such a collaborative program for the medical device OEM’s, suppliers, patient safety, product quality, compliance, and effective QMS implementation• include risks and benefits associated with the programRavi Nabar, Senior Director, Supplier Quality ManagementPHILIPS HEALTHCARE


PHARMACEUTICAL SESSIONS8:50 INSTITUTING RISK MANAGEMENT PROCEDURES INTO MANUFACTURING OPERATIONS TO PREVENT QUALITY DISCREPANCIESQuality risk management (ICH 9) is not an exact science, but a data driven and systematic process utilized within the pharmaceutical industry to de-tect non-conformities that could derail the safety and efficacy of a product. The outcomes of QRM are highly dependent upon overall technical under-standing, experience, available tools and management support. Proper in-tegration of QRM into a product’s quality system allows executives to apply the apt amount of controls to contain discovered decencies to assure the product functions within the predetermined threshold of acceptable risk. • Promoting QRM within company culture to establish proactive behaviors• Investigating available risk assessment methodologies• Understand the complexity of issue or process to determine reactionChad Westhoven, Associate Director, Quality & ComplianceGRIFOLS


10:35 INTERACTIVE WORKSHOP: ENGAGING IN EXTENSIVE CAPA PROGRAMS TO ENSURE OVERALL PRODUCT QUALITY & EFFICACY From October 2011 through September 2012 the CDRH issued 181 warn-ing letters to organizations throughout the medical device industry. As has been the trend over the last few years, CAPA remains the most frequently cited deficiency discovered during FDA inspections. Through this interac-tive workshop, executives will partner in small groups to work through com-mon CAPA scenarios exploring effective problem solving and improvement methodologies that can be applied within CAPA subsystems. TJ Dotson, Director, Quality Assurance GE HEALTHCAREChris Hoag, Associate Director, Corporate CAPA SystemsSTRYKER

10:35 APPLICATION OF EXHAUSTIVE VALIDATION AND RE-VALIDATION STRATEGIES TO SUSTAIN CONTINUED PRODUCT QUALITY COMPLIANCEValidation remains the foundation of a strong product quality system to authenticate the efficacy and suitability of materials, processes, and equip-ment. Manufacturing and quality executives must possess extensive com-prehension regarding the requirements and strategies for all forms of vali-dation in order to properly certify that a product will perform as intended in real-world environments. The following 30-minute presentations will high-light the challenges and strategies for three specific forms of validation:30-Minute Presentation: Process ValidationMonica Lent, Sr Manager, Process Validation & Knowledge ManagementGENENTECH

30- Presentation: Software ValidationDave Chlebda, Senior Director, Regulatory OperationsTEVA PHARMACEUTICALS *Pending Final Confirmation

25-Minute Follow- Up Q&A with Validation PresentersDave Chlebda, Senior Director, Regulatory OperationTEVA PHARMACEUTICALS *Pending Final ConfirmationMonica Lent, Sr Manager, Process Validation & Knowledge ManagementGENENTECH

12:00 NETWORKING BREAK & LUNCHEON FOR ALL PARTICIPANTS

• Supply Chain• Plant Operations• Packaging/Labeling

WHO SHOULD ATTEND:Executives that will be most interested in participating in this program will be those leading the manufacturing arm of pharmaceutical, biotechnology, medical device and diagnostic corporations. Job titles of executives that will be most applicable for this program include Presidents, Senior & Execu-tive VP’s and Directors of:• Manufacturing• Operations• Quality Assurance• Engineering

• Supply Chain• Plant Operations• Packaging/Labeling

DAY TWO / FRIDAY, OCTOBER 115TH ANNUAL PHARMACEUTICAL & MEDICAL DEVICE MANUFACTURING & QUALITY ASSURANCE FORUM


CROSS INDUSTRY SESSION3:45 INTERACTIVE WORKSHOP: INCREASING OVERALL QUALITY COMPLIANCE STANDARDS THROUGH COMPREHENSIVE TRAINING PROGRAMSIn the first half of 2012, the FDA reportedly issued nearly 300 warning letters of which more than half of the recipients were pharmaceutical, medical device or dietary supplement manufacturers. The continual rise in warning letter issuances combined with a 2-year high in product recalls in 2012 has placed a spotlight on quality training in the life science industry. This interactive workshop will showcase thorough and proactive training techniques companies can utilize to ensure employees, from management to facility operators, possess a comprehensive knowledge of current cGMP regulations.Tina Stiles, Associate Director, Corporate QA Training , MILLENNIUM PHARMACEUTICALS

4:30 CLOSING REMARKS AND PROGRAM CONCLUSION

PHARMACEUTICAL SESSIONS1:00 ENHANCING REGULATORY INSPECTION READINESS LEVELS WITH THE EMPLOYMENT OF INTERNAL QUALITY AUDITSUtilization of internal quality audits within facilities ensures that the orga-nization’s quality system can withstand a regulatory inspection conducted by health authorities and provides assurance that products are maintain-ing the highest possible quality standard. Pharmaceutical companies who conduct detailed audits on all manufacturing and quality processes are better equipped to identify potential areas of non-compliance and quickly resolve identified discrepancies. The successful implementation of an in-ternal audit can boost operational efficiency, control costs, and increase risk management practices within manufacturing facilities.• Determine auditors duties and responsibilities• Monitoring audit data collection• Implementing corrective action plans in response to discrepanciesMelissa Seymour, Sr Director, Corporate GxP Compliance & Quality SystemsBIOGEN IDEC

1:45 DESIGN AND EXECUTION OF CHANGE CONTROL MANAGEMENT PROCESS WITHIN MANUFACTURING OPERATIONS Drug manufacturers face an extremely high level of scrutiny from both the FDA and consumers regarding the quality of products; therefore when any changes that impact the overall product efficacy is implemented it must be properly recorded and stored. Process and material changes have the po-tential to be very disruptive to the manufacturing process, the institution of stringent control management practices allow executives to reduce any dis-ruptions and ensure changes occur at the right phase in a product’s life cycle.• Balance overall change impact with the cost of change implementation• Classifying and approving proposed alterations• Implementation planningJill Neri, Change Control Manager, GENZYME


3:00 ADVANCEMENT AND ADOPTION OF QUALITY BY DESIGN PRINCIPLES WITHIN MANUFACTURING AND QUALITY PROCEDURESAs the push for greater quality and efficacy standards increase, the phar-maceutical industry continues to question how to get the best value from the large investment required to employ quality by design practices. QbD allows companies to define a preferred level of product functionality and effectively build in the appropriate quality parameters during a product’s developmental stage. This presentation will highlight best practices and strategies of initiating the QbD systematic approach to assist in building quality into a product on the front-end and reduce the probability of non-conformities during the manufacturing process.Chris Balducci, Technical Research & Development Network LeaderNOVARTIS

MEDICAL DEVICE SESSIONS1:00 EFFECTIVE INTERNAL AUDITING PRACTICES TO ENSURE FACILITY’S PREPAREDNESS FOR REGULATORY INSPECTIONS• Identification of focal areas to address during audits• Promoting the benefits of audits to management committees• Techniques and strategies to maximize effectiveness of quality audits• Assessing audit results and outcomes to measure facility’s inspection readiness levelElena MackDirector, Quality Assurance & RegulatoryORASURE

1:45 OUTLINING THE SIGNIFICANCE OF RISK MITIGATION STRATEGIES THROUGHOUT THE PRODUCT LIFECYCLERisk management and mitigation is the practical application of strategies to proactively alleviate or reduce the risk of device failure in real-world en-vironments whether triggered by a design flaw or user error. Severity is a key component within any risk management analysis; it is the vital re-sponsibility of quality executives to benchmark acceptable ranges of risk for products and ensure devices consistently reside within that acceptable risk threshold to secure compliance with safety regulations. • Review the implications of EN ISO 14971:2012 update within EU market• Risk analysis implementation strategies and tools • Preliminary Hazards Analysis (PHA) • Failure Tree Analysis (FTA)• Lessons learned from prior risk mitigation assessmentsJames TillmanVP, Quality and Regulatory Compliance InitiativesDANAHER CORPORATION

3:00 NAVIGATING THE INTRICACIES OF CHANGE CONTROL MANAGEMENT SYSTEMS WITHIN MANUFACTURINGFDA regulations 21 CFR Part 820 states that manufacturing organizations must have a well constructed system in place to monitor and track all changes made to a product. Whether to the design or simply the technol-ogy used to assemble the product, change control is a core competency within a manufacturing facility’s quality management system (QMS). It is crucial for quality executives to employ thorough change control methodol-ogies to ensure open access and retrieval of information during regulatory audits to showcase absolute quality compliance. • Integrating flexibility into QMS to allow for thorough change control• Debate what level of change requires re-submission for approval to regulatory authorities• Creation of change forms and request management processesKent Pruett, Director Quality Assurance & Regulatory AffairsFUJIREBIO DIAGNOSTICS


SPONSORSHIP OPPORTUNITIES:At this time, there are a variety of sponsorship and exhibition opportunities available for companies wishing to increase their visibility and participation in the program, ranging from keynote speaking opportunities through to ex-hibitor and documentation sponsors. Organizations most suitable for this type of exposure provide services and solutions including:• Contract Manufacturing• Electronic Manufacturing Systems• Inventory Management Systems• Anti-counterfeit/Verification Technologies• Risk Management Systems

• Supply Chain Forecasting & Demand Software• Sterilization Technology& Clean Room Services• Regulatory & Quality Assurance Consultants• Facilities Management & Equipment• Raw Materials/API Manufacturers

5TH ANNUAL PHARMA & DEVICE MANUFACTURING & QUALITY ASSURANCE FORUMOCTOBER 10-11, 2013 | SAN ANTONIO, TX

MTS Manufacturing Manager – 3MFellow, Sterilization – ABBOTTVice President, Operations – ADVANCED BIONICSSenior Director, Manufacturing – AGENNIXAssociate Director, Quality – ALCONQA Project Manger – ALCONDirector of Operations – ALLERGANVice President of Quality – APERION BIOLOGICSDirector of Quality Assurance – APOCELL, INCChief Regulatory Officer, VP Quality – ARTHROCAREVice President, Quality Operations – B. BRAUN MEDICALManager, Design Control Office – BAXTER HEALTHCAREDirector, Quality Assurance & Compliance – BECTON DICKINSONAssociate Director, Drug Compliance – BIOGEN IDECVice President, Operations – BIOMEDICAL ENTERPRISESenior Manager, Global Design Assurance – BOSTON SCIENTIFICVice President, Quality Optimization – BOSTON SCIENTIFICSenior Manager, Validation Lifecycle – BRISTOL-MYERS SQUIBBGlobal Vice President QA Sterilization – COVIDIENUDI/GSI Program Corporate Lead – COVIDIENAssociate Director, Quality – DAIICHI SANKYODirector, Quality Assurance – DJO GLOBALQuality Manager – EMINENT SPINEDirector, Technical Operations – ENDO PHARMACEUTICALSPlant Manager – ETHICONDirector, QA/RA – FUJIREBIO DIAGNOSTICSHead, External Quality, Validation & QE – GENENTECHDirector, SSFP Production Services – GENENTECHAssociate Director, Quality & Compliance – GRIFOLSSenior Director of QA – HEALTHPOINT BIOTHERAPEUTICS


2012 EVENT ATTENDEES INCLUDE:Senior Manager, Quality Systems – HOLLISTER INCORPORATEDQA Training Supervisor – HUMAN GENOME SCIENCESQA Director – IDEV TECHNOLOGIESDirector, QA & RA - INNOVATIVE NEUROTRONICSVice President, Regulatory – INOVA LABSSupplier Quality Manager – KCI MEDICALSenior Director, Product Supply, Device - KIMBERLY CLARKDirector, Quality Systems – LANXR&D Engineer – LDR SPINEDirector, Global Quality Systems – LIFE TECHNOLOGIESDirector of Manufacturing – MAKO SURGICALQuality Manager – MEDLINE INDUSTRIESSenior Quality Systems & Quality Control – MEDTRONICAssociate Director, Business Consulting – MERCKDirector, QA & Quality Control – MILLENNIUM PHARMACEUTICALSDirector of Quality Assurance – NEOS THERAPEUTICS Director, Quality Engineering – NOVEN PHARMACEUTICALSDirector of Engineering – ORASURE TECHNOLOGIESPresident – PARI RESPIRATORY EQUIPMENTSenior Manager, Quality Engineering – PURDUE PHARMAAssociate Director, Quality Assurance – REATA PHARMAAssociate Director, Quality Assurance – RELYPSADirector, Industrial Quality Assurance – SORIN Director, Quality Affairs – SPINAL RESTORATION BIOLOGICSSenior Manager, Strategic Supplier Eng. - ST. JUDE MEDICALSenior Manager, Manufacturing Engineering – ST. JUDE MEDICALSenior Director, Global Quality Excellence – STRYKERAssociate Director, Corp. CAPA Systems – STYKERSenior Director, Manufacturing & Engineering – THORATECDirector of Product Development – XERIS PHARMACEUTICALS

RELATED WEBINAR:ENSURING ADEQUATE PROCESS IMPLEMENTATION AND ADHERENCE IN CAPA SYSTEMS

• Strategic CAPA management on local and global levels• CAPA warning letter and violation trend analysis• Differentiating between corrections, corrective actions and preventive actions• Key considerations when evaluating CAPA tools

TARGET AUDIENCE:JOB TITLES:• Quality Assurance/ Quality Systems• CAPA Managers• Quality & Compliance• Manufacturing & Operations• Regulatory

INDUSTRIES REPRESENTED:• Pharmaceuticals• Medical Device• Biotechnology

DISTINGUISHED PRESENTER:Lonnie Lassmann, Senior Director Global Quality SystemsKCILonnie Lassmann currently serves as Sr. Director, Global Quality Systems for KCI. Lonnie has over 19 years experience in the medical device and aerospace industries working in various functional areas including operations, engineering, and quality. He is ASQ certified in CMQ/OE and CQA and is a certified Six Sigma Black Belt. He has a Master’s Degree in Business and a B.S. in Biomedical Engineering. He has been an active community volunteer serving on the board and committees for a variety of non-profit organizations, including the Quality Texas Foundation as a Board Examiner for the Baldrige Criteria for Performance Excellence.

Thursday, August 22, 2013 / 12 PM EST

REGISTER NOW! www.q1productions.com/?p=1793

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OCTOBER 10-11, 2013 5th Annual … · pharmaceutical & medical device manufacturing & quality assurance forum ... 9:15 genentech case study: ... pharmaceutical & medical device manufacturing