This course offers a foundational understanding of technology transfer specific to solid dosage forms, blending theoretical insights with practical applications. Through interactive sessions and case studies, participants will explore best practices for scale-up and technology transfer, strategise for smooth transitions, and master the critical do’s and don'ts of the process. Real-world examples will be analysed to highlight practical challenges and solutions, equipping learners with the tools needed for effective implementation in the pharmaceutical industry.
Benefits of attending
- Gain practical knowledge from interactive sessions and case studies
- Learn an outline of the proven best practices for scale-up and technology transfer
- Discover how to strategise for a seamless technology transfer
- Enhance your understanding of the do’s and don’ts during technology transfer
- Analyse real-world examples to understand practical application and challenges
Certifications:
- CPD: 6 hours for your records
- Certificate of completion
Course Content
Quality by design principles during process development and scale-up
- Pharmaceutical QbD: why is it needed? What is it?
- The importance of a good quality target product profile
- How to best identify critical quality attributes, critical material attributes and critical process parameters
- Examples of QbD for different formulations
Quality by design principles during process development and scale-up
- Risk and science-based development: how to apply ICH Q9
- Process control strategy: how to build an appropriate control strategy
- Risks for solar dosage formulations: overview and examples
- Case study in groups
Technology transfer challenges
- When/why to perform a technology transfer
- How to perform a technology transfer: ideal vs real life examples
- Outsourcing and its challenges (also from a CMO perspective)
Planning for a seamless technology transfer
- How to assemble a tech transfer team
- Planning: activiteit and documentation
- Example: best practices at sending and receiving site
- The importance of engineering runs
- Case study
Course Provider
Laura Buttafoco,
ProteaLaura’s areas of expertise include CMC strategy, technology transfer, process scale-up, validation, program management, GMP compliance and risk management. Laura has spent nearly 20 years in the industry where she has contributed to both small and large molecule projects. Acting as the main point of technical contact, as well as project/program manager, she has been responsible for completion of technology transfer and exhibit batches production in cooperation with various CMOs in EU, India and China. Currently she operates as independent consultant for Protea, her own company. In this role, she has worked on a variety of therapeutics and she has a proven track record of successfully closed large Capex assignments on behalf of medium as well as large and well-established pharmaceutical companies.
Who Should Attend
- Project managers
- Tech transfer specialists
- CMO managers
- R&D process managers
- Manufacturing project managers
