Course overview
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.
CPD Hours: 6
Course Content
- Day 1
- Quality by design principles during process development and scale-up
- Quality by design principles during process development and scale-up
- Technology transfer challenges
- Planning for a seamless technology transfer
Speakers
Laura Buttafoco
Laura’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 (www.protea.services). 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.
