Event Date/Time: Nov 19, 2009 End Date/Time: Nov 20, 2009
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Available as an in House Training Course

Technology Transfer for the Pharmaceutical Industry

Course Dates:19 & 20 November 2009

Venue: Window Conference Venue, Islington London UK

Cost: £1160 + VAT £174.00 (Total £1334.00) (10% discount if booked and paid by Friday 4 September)

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


Chris Barnett, Director CMBarnett Pharma Services Ltd