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  Events - December 2012


Technology Transfer (3 day)

05 Dec 2012 - 07 Dec 2012 - London, UK



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Course overview:

This three-day interactive workshop is intended to provide an overview of the challenges that must be overcome in transferring manufacturing technology and to highlight some proven techniques for overcoming those challenges.
The focus of the course is on small-molecules and their formulations rather than biological products, although many of the issues faced and techniques discussed will be equally applicable.

Some of the benefits to be derived from this workshop include:
. An appreciation of where TT fits in the life cycle of a pharmaceutical product.
. An appreciation of the importance of planning and project
management in TT.
. An overview of the potential complexity of technology and product transfer.
. An outline of proven best practice in technology transfer.
. An opportunity to discuss current issues and challenges in technology transfer with peers and with an expert faculty.
. A consideration of “where next” as we move from traditionally-developed products to a world where products are developed using QbD techniques and controlled by PAT.

Who should attend?
Pharmaceutical technologists, Quality Assurance staff, Regulatory staff, Engineering staff, Project Managers and anybody else involved in the transfer of products or technology from one location to another.
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
Logistical 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

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 subsequently 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 development 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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