Event Date/Time: May 19, 2010 End Date/Time: May 20, 2010
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Description

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

Venue

Types