In House Training Course

Technology Transfer

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