PharmaTraining Limited, Window Conference Venue, 13 Windsor Street, Islington, London, N1 8QG, United Kingdom
2011-11-07
This 2-day interactive workshop is intended to provide an overview of the challenges that must be overcome in transferring technology and to highlight some proven techniques for overcoming those challenges. 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. 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. PROGRAMME Start time:
Coffee and registration will be available from 8.30am on Monday 7 November, course proper will commence at 9.00am. We anticipate the course will finish at 5.00pm on Tuesday 8 November 2011. 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. Evening reception Day 2
Technical Challenges
Manufacturing processes. Validation. Stability. Packaging processes. Logistical Challenges
Label Changes:Text. Physical. Timing: Project Plan. Phase in/out Human challenges
Push versus Pull. Team membership and team roles. Cross-Cultural Issues. Progress Reporting and breaking bad news
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