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Note: payment must be received prior to attendance. Sign and date Please invoice my company Address I would like details for an additional guest and/or additional nights. Country I would like a non smoking room Order No. By Invoice $5000 Other special needs Options A three day residential course introducing the theory and techniques associated with the FDA’s Process Analytical Technology initiative in association with Position Email Zip City Automation Ltd. ✓ ✓ ✓
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Duquesne University
in association with
Optimal Industrial Automation
Present
Practical Implementation of PAT in the Pharmaceutical Manufacturing Industry
26th - 28th April 2005
Location - Omni William Penn Hotel –Pittsburgh, PA
A three day residential course introducing the theory and techniques associated with the FDA’s Process Analytical Technology initiative
Speakers:
Dr. Ali Afnan - Visiting Scientist – U.S. Food and Drug Administration (FDA), Office of Pharmaceutical Science (OFS), Center for Drug Evaluation and Research (CDER)
Dr. Chris Watts - Staff Fellow - U.S. Food and Drug Administration (FDA), Office of Pharmaceutical Science (OFS), Center for Drug Evaluation and Research (CDER)
Dr Jim Drennen - Associate Professor of Pharmaceutics and Head, Pharmaceutical Sciences Division - Duquesne University Director - Duquesne University Center for Pharmaceutical Technology (DCPT)
Dr Carl Anderson - Assistant Professor of Pharmaceutical Sciences - Duquesne University Faculty Researcher - Duquesne University Center for Pharmaceutical Technology (DCPT)
Dr Gawayne Mahboubian-Jones - synTQ Product Manager, Optimal Industrial Automation Ltd.
Booking Details
Enjoy a unique opportunity to interact with regulators and researchers in this rapidly emerging field. Gain first hand knowledge of the utility of PAT tools using laboratory-scale pharmaceutical manufacturing equipment.
PAT - The future
of Pharmaceutical
Manufacturing
Name
Position
Company
Address
City
PostCode
Country
By Invoice $5000
Options
Payment Details Please invoice my company ✓
Note: payment must be received prior to attendance.
Order No.
I would like a non smoking room ✓
I would like details for an additionalguest and/or additional nights. ✓
Sign and date
Dr. J.K. Drennen III Dept. Pharmaceutical Sciences, Duquesne Univeristy, 600 Forbes Avenue, Pittsburgh, PA 15282 USA Email: [email protected], Fax: 412.396.4660, Phone: 412.396.6315.
SocialSecurity #
Zip
Other special needs
FeesCourse Fee $5,000
Fee Includes:All tuition and course material.Three nights accommodation at the historic William Penn Hotelincluding meals.
How to BookPlease use the enclosed booking form or apply direct to:Dr James K Drennen, IIIDuquesne UniversityEmail: [email protected]: 412-396-6315or contact:Optimal Industrial Automation LtdGoodrich CloseWesterleigh Business Park
Yate Bristol BS37 5YT
Email: [email protected]
Please note
If you would like to book extra nights accommodation for persons not attending the course we would be pleased to arrange this for you.
Duquesne UniversityDuquesne University faculty have been working at the forefront of Process Analytical Technology through its inception and work closely with the pharmaceutical industry. They have practical experience with implementation of PAT methods in manufacturing facilities.
Optimal Industrial Automation LtdOptimal has a long history of
automation systems integration within the pharmaceutical industry. They have carried out major projects for most of the large manufacturers and have an
enviable reputation for the delivery
and support of high quality systems around the world. Optimal has developed a data management tool, synTQ, for use in PAT applications. During its development, Optimal has been closely involved with the PAT initiative and are represented on the ASTM E55 PAT Steering committee.
This course gives a unique insight into techniques and theory behind the implementation of Process Analytical Technology in the Pharmaceutical Manufacturing arena. It is being presented by Duquesne University of Pittsburgh USA in association with Optimal Industrial Automation of Bristol UK.The basic structure of the course will be discussions of theory and application in the morning sessions, followed by practical experimental sessions in the afternoon. Delegates will have the opportunity to collect and analyse real data from laboratory scale pharmaceutical processing equipment. The concepts to be explored during the course are derived from the recent FDA Guidance.
PAT—A framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance—September 2004PAT
ExperimentsDrying Process
Tray drying is a common practice
in many pharma companies and
is often difficult to control. NIR
Sensors are used to monitor and control a lab scale version of this process, enhancing the quality and reproducibility of its output.
Blending Process
Controlling the endpoint of blending processes can provide
improved content uniformity for solid oral dosage forms. An on-board NIR sensor is used to monitor and control a lab-scale bin blender.
Program
Monday 25th April Welcome Reception
Tuesday 26th April
9.00 – 9.30Registration and Coffee
9.30 – 9.45Introduction Jim Drennen/Carl AndersonCourse Objectives Course structure
9.45 – 10.30PAT OverviewChris WattsRegulatory Perspective of PAT• What is PAT• Why is PAT necessary• What benefits will industry/ agency/public achieve with PAT
10.30 - 11.00Coffee
11.00 – 11.30ImplementationJim DrennenKey Elements for PAT implementation • Risk analysis• Experimental design• Control strategies• Model development and transfer• Process sampling• Information management
11.30 – 12.00Risk Analysis Gawayne Mahboubian-Jones• Types of Risk Analysis• Techniques• PAT During Process Design• PAT for Existing Processes• Identification of Potential Critical Control Parameters• Examples
12.00 – 13.00Experimental DesignCarl Anderson/Ali Afnan• Expected Outcomes • Screening/Feasibility• Design Structure • Variable Selection• Parameter Significance Testing• Study Type• Data Analysis• Significance Levels
13.00 – 14.00Lunch
14.00 – 17.00Lab Exercise Day 1
Blending (group 1)Drying (group 2)
Wednesday 27th April
9.00 – 10.00Potential Control StrategiesCarl Anderson /Gawayne Mahboubian-Jones• Review of Measurement Technologies • Sampling • Process understanding from multivariate analysis • Process modelling
10.00 – 10.30 Coffee
10.30 – 11.30Implementation of Control StrategiesGawayne Mahboubian-Jones• Systems Integration• Data Management• Control Strategies• Examples
11.30 – 12.30 Optimization and ReviewChris Watts/Ali Afnan• Achieving Process Targets • Continuous Learning and Improvement• Assessment of Process Understanding• Control Strategies• Regulatory Submission • Documentation/Feedback• Examples
12.30 – 13.30Lunch
13.30 – 17.00Lab Exercise Day 2Blending (group 2)Drying (group 1)
Thursday 28th April
9.00 – 11.30Review and Discussion of Experimental Work
11.30 – 13.00Lunch
13.00Close
Note – Details of the Program are
subject to change
Course ObjectivesPAT InitiativesDiscuss the current thinking
around PAT issues with regulatory
and scientific experts.
The Validation ProcessLearn about the new philosophy
for validation of pharmaceutical systems.
Data ManagementGain practical experience with leading edge data management
techniques.
InstrumentationConduct practical experimentation
using modern PAT instrumentation
and techniques.
ChemometricsUse multivariate analysis techniques to achieve process
understanding from unit operations data.
Tel: 01 454 333222
