Technology Transfer (3 day)
Venue: Window Conference Venue
|Event Date/Time: Jul 02, 2012||End Date/Time: Jul 04, 2012|
|Registration Date: Jul 02, 2012|
|Early Registration Date: May 07, 2012|
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 â€œwhere nextâ€ as we move from traditionally-developed products to a world where products are developed using QbD techniques and controlled by PAT.
Chris Barnett is an independent GMP and compliance consultancy. Chris has a talent for coaching and explaining complex regulations in a straightforward man-ner.
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.
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.
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.
Why Transfer Technology?
. Pharmaceutical Product Life Cycle
. Product Transfers and Technology Transfers
. Regulatory Considerations
. Registration Procedures
. Variation Procedures
. Types of Variations
. Advantages and Disadvantages
. Manufacturing processes
. Packaging processes
. Label Changes
. Project Plan
. Phase in/out
Technical Challenges (2)
. Impact of new technology
. Quality by Design
. Process Analytical Technology
. Push versus Pull
. Team membership and team roles
. Cross-Cultural Issues
. Progress Reporting and breaking bad news