Add course dates to your calendar
22/23 November 2010
Venue Window Conference Centre, London
Speaker Chris Barnett
Cost £1160 + UK VAT
Early-bird rate £1044 + UK VAT if booked and paid by 15 September 2010
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Overview
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 product transfer
- 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
Day 1
Why Transfer Technology?
• Pharmaceutical Product Life Cycle
o Development
o Innovative
o Mature
o Generic
• Product Transfers and Technology Transfers
o IP
o Technology
o Techniques
Regulatory Considerations
• Registration Procedures
o Europe
o Non-European
• Variation Procedures
o Types of Variations
o Advantages and Disadvantages
Day 2
Technical Challenges
• Manufacturing processes
• Validation
• Stability
• Packaging processes
Logistical Challenges
• Label Changes
o Text
o Physical
• Timing
o Project Plan
o Phase in/out
Human Challenges
• Push versus Pull
• Team membership and team roles
• Cross-Cultural Issues
• Progress Reporting and breaking bad news
