26 Jun 2013 - 28 Jun 2013 - London, UK
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
Some of the benefits
to be derived from this workshop include:
- An appreciation of where TT fits in the life cycle of a
- An appreciation of the importance of planning and project
management in TT
- An overview of the potential complexity of technology and
- 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?
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.
Product Life Cycle
Product Transfers and
- Regulatory Considerations
- Types of Variations
- Advantages and Disadvantages
- Manufacturing processes
- Packaging processes
- Label Changes * Text * Physical
- Timing * Project Plan * Phase in/out
Impact of new
- Quality by Design
- Process Analytical Technology
- Push versus Pull
- Team membership and team roles
- Cross-Cultural Issues
- Progress Reporting and breaking bad news