PharmaTraining Ltd, London UK
26 to 28 June 2013
This three-day interactive workshop is intended to provide an overview of the challenges that must be overcome in transferring manufacturing technology and to highlight some proven techniques for overcoming those challenges. The focus of the course is on small-molecules and their formulations rather than biological products, although many of the issues faced and techniques discussed will be equally applicable. 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.
- A consideration of 'where next' as we move from traditionally-developed products to a world where products are developed using QbD techniques and controlled by PAT.
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.Course ProgrammeDay 1Why Transfer Technology? Pharmaceutical Product Life Cycle - Development
- Innovative
- Mature
- Generic
Product Transfers and Technology Transfers - IP
- Technology
- Techniques
- Regulatory Considerations
Registration Procedures Variation Procedures - Types of Variations
- Advantages and Disadvantages
Day 2Technical Challenges - Manufacturing processes
- Validation
- Stability
- Packaging processes
Logistical Challenges - Label Changes * Text * Physical
- Timing * Project Plan * Phase in/out
Day 3Technical Challenges (2) Impact of new technology - Quality by Design
- Process Analytical Technology
Human Challenges - Push versus Pull
- Team membership and team roles
- Cross-Cultural Issues
- Progress Reporting and breaking bad news
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