This course identifies criteria for successful TT and provides ‘how to’ examples which can be individually tailored, depending on the type and scope of transfer. It takes into account current industry challenges and real-world examples as tools for industry and regulators to use when conducting and evaluating technology transfer activities.
Who Should Attend
- Anyone involved in technology transfer whether in relation to commercial transfer between manufacturing sites or transfer to manufacturing from development or within development.
- Professionals with technology transfer responsibilities, including regulatory compliance associates, process development scientists, facilities engineers, validation and quality assurance specialists, manufacturing managers, and regulators.
- Introduction to Technology Transfer
- Knowledge Management: What is it?
- Planning & Success Criteria
- Quality Risk Management
- Phases of the Transfer Process, including Validation
- Analytical Procedures Transfer
- Transfer of Drug Product
Quality metrics are used throughout the pharmaceutical industry to monitor
Thermal Mapping and Qualification Studies
Understand the Risk-Based Approach of Thermal Mapping