PharmaTraining Limited, Window Conference Venue, 13 Windsor Street, Islington, London, N1 8QG
5 - 7 December 2012
Start time:
Coffee and registration will be available from 8.30am, course proper will commence at 9.00am. We anticipate the course will finish at 5.00pm.
Day 1
Why Transfer Technology?
. Pharmaceutical Product Life Cycle
. Development
. Innovative
. Mature
. Generic
. Product Transfers and Technology Transfers
. IP
. Technology
. Techniques
. Regulatory Considerations
. Registration Procedures
. Europe
. Non-European
. Variation Procedures
. Types of Variations
. Advantages and Disadvantages
Day 2
Technical Challenges
. Manufacturing processes
. Validation
. Stability
. Packaging processes
.ogistical Challenges
. Label Changes
. Text
. Physical
. Timing
. Project Plan
. Phase in/out
Day 3
Technical Challenges (2)
. Impact of new technology
. Quality by Design
. Process Analytical Technology
. Human challenges
. Push versus Pull
. Team membership and team roles
. Cross-Cultural Issues
. Progress Reporting and breaking bad news
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Invited Speakers:
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Course Leader:
Chris Barnett is an independent GMP and compliance consultancy. Chris has a talent for coaching and explaining complex regulations in a straightforward manner. An expert in quality management, technology transfer and new product introduction, Chris specialises in Quality Management, Technology Transfer and New Product Introduction.
Chris has a background as an analytical chemist and over 20 years experience in QA roles, with the Wellcome Foundation and GlaxoSmithKline. He has had QA management posts in India and Mexico, as well as new product introduction project management roles in pharma manufacturing. Chris graduated from Cambridge in natural sciences, with an MSc in analytical chemistry, and subse-quently an MBA from Greenwich University.
Guest Lecturer:
Michael Gamlen is Managing Director of Pharmaceutical Development Services Ltd, a pharmaceutical consultancy based in Nottingham (UK). Dr Gamlen has over 30 years experience in the pharmaceutical industry. Michael specialises in managing product development, formulation, tablet and process evelopment studies. He has been teaching professional courses for many years and his courses are highly rated, exceeding the expectation of the participants in many cases.
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