Course overview
As global operations grow more complex and outsourcing and accelerated launches become common, robust technology transfer process is essential to ensure product quality and supply continuity.
This two-day training course provides a comprehensive understanding of technology transfer, aligned with international regulatory guidelines ((FDA, EMA, MHRA, WHO, ANVISA, ICH Q7-Q12, EU GMP Annex 15, WHO TT guidance) and current industry expectations.
Participants will learn how to plan, execute, and manage technology transfer activities using science and risk-based methodologies. and how TT fits within the product lifecycle and the PQMS. It integrates current hot topics - such as digitalization (Pharma 4.0 tools), data integrity, and advanced regulatory frameworks - into the foundational principles of effective tech transfer.
Emphasis will be placed on the co-ordination between Sending and Receiving Units, addressing facility and equipment differences, and integrating Quality by Design (QbD) and Quality Risk Management(QRM) principles into transfer strategies.
Participants will also learn how to create transfer protocols, perform detailed gap analyses, use knowledge transfer practices, and regulatory-aligned documentation to ensure GMP compliance throughout.
The course includes Analytical Method Transfer and is designed to support a variety of operational models including small molecules, biologics, combination products, and outsourced manufacturing and as a result provides a practical framework for executing reliable, compliant transfers across diverse settings.
CPD Hours: 12
Course Content
- Day 1
- Day 1: Foundations and regulatory framework
- Module 1: Introduction of technology transfer
- Module 2: Global regulatory expectations
- Module 3: Quality by design and risk management
- Module 4: Planning and management of tech transfer project
- Exercise 1: Design a tech transfer plan
- Module 5: Transfer documentation & knowledge management
- Exercise 2: Create a transfer protocol
- Module 6: Regulatory and GMP compliance in transfers
- Day 2
- Day 2: Execution, analytical transfer and lifecycle management
- Module 7: Process execution at the receiving unit
- Module 8: Facility, equipment, and material adaptation
- Module 9: Analytical method transfer (AMT)
- Exercise 3: Analytical method transfer protocol creation
- Module 10: Training, knowledge transfer and troubleshooting
- Module 11: Post-transfer regulatory and lifecycle management
- Module 12: Case studies and emerging trends
Speakers
Paul Palmer
Paul R Palmer is a Director / Pharmaceutical Consultant and a practicing EU / UK Qualified Person. He has over 35 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices.
Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerised systems, as well as the facilities and services to support each.
People and systems have always been a core focus, how to ensure best use, optimise and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.
Paul studied psychology as part of his MSc in 1993 and has always enjoyed observing the world around him with a curiosity that is rarely satisfied.
