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.
Why Transfer Technology”
Pharmaceutical Product Life Cycle
Product Transfers and Technology Transfers
- Regulatory Considerations
- Types of Variations
- Advantages and Disadvantages
- Manufacturing processes
- Packaging processes
- Label Changes * Text * Physical
- Timing * Project Plan * Phase in/out
Technical Challenges (2)
- Risk Management and Technology Transfer
- Push versus Pull
- Team membership and team roles
- Cross-Cultural Issues
- Progress Reporting and breaking bad news
Michael Gamlen (Tableting and Stability Testing Expert)
Michael is managing director of Pharmaceutical Development Services Limited, a Nottingham UK-based technical consultancy. Michael has over 30 years experience of tablet development. Awarded a first class honours degree in pharmacy, specialising in pharmaceutical engineering. He studied for a PhD at Nottingham University. He was head of tablet development at the The Wellcome Foundation for 15 years, and has since worked for Vanguard Medica Limited and as a consultant. He specialises in managing product development, formulation, tablet and process development studies. He has been teaching professional tabletting courses for many years. His courses are highly rated, often exceeding the expectation of participants.
Michael continually updates the content of his courses with guidance and extracts from latest scientific papers. He provides a substantial amount of relevant literature to all course participants and copies of all notes and guidance used. He is very popular presenter.
Chris Barnett (QP)
Chris is an independent GMP and compliance consultancy. Chris has a talent for coaching and explaining complex regulations in a straightforward manner. Chris is an expert in quality management, technology transfer and new product introduction.
Chris has a background as an analytical chemist and over 20 years experience in QA roles, with the Wellcome Foundation and GlaxoSmithKline. He has had QA management posts in India and Mexico, as well as new product introduction project management roles in pharma manufacturing. Chris ran his own consulting company for several years prior to joining PDS in 2002.
Chris graduated from Cambridge in natural sciences, with an MSc in analytical chemistry, and subsequently an MBA from Greenwich University.
Three roles in major multinationals over a ten-year period:
New Products Sourcing Project Manager
- Responsible for liaison between early-stage Drug Development and Global Manufacturing and Supply for new chemical and biological entities being developed in Italy and the UK. Represented Global Manufacturing and Supply on the respective R&D Project Teams (Pre-Clinical, Ph 1, 2, 3) for the various NCE/NBEs.
- Gained senior management agreement for the long-term manufacturing strategy for three new chemical / biological entities and line extension products.
- Led the team developing the manufacturing strategy for a viral vaccine, working with Biologicals development and external contractors to develop a plan for capital investment leading to fully validated commercial primary production suite.
Project Manager, Product Introduction Planning Group
- Led teams of technical, logistics and other staff to achieve validated, cost-effective and timely transfer of responsibility for new product supply from R&D (Ph 2, 3, 4) to the factories, leading to global product launch. Supervised the work of the respective technology transfer teams.
- Member of the core R&D project team for the freeze-drying of a live viral vaccine, leading the R&D/Procurement/Manufacturing team to select a third-party contractor for freeze-drying a viral vaccine from the setting of initial selection criteria and market surveys, via tender document review, through to site visits and assessment audits.
- Managed the team transferring a new fermentation process for a therapeutic protein from R&D to Commercial Production, including scale-up and validation, and preparation of the secondary production area for regulatory inspection.
- Led the team assessing and selecting the packaging contractor for a highly-potent and toxic oral dosage form.
- Brought eight products through regulatory submission and launch, and a further five through significant development milestones. This included the transfer of intellectual property and manufacturing technology as a divestment following a major corporate acquisition.
International Product Introduction Manager
- Invited to establish a new role within the company, managing the transfer of new products from R&D into Production.
- Joined R&D Development Project Teams from Ph 2 onwards, working closely with the Team Leaders and Planners, advising on the manufacturing/operational aspects of new product development.
- Coordinated teams of technical, logistics and other staff in achieving validated, cost effective and timely transfer of responsibility for drug supply for three new chemical entities.
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.
“The course was quite informative and the discussions with the group we of great value, this will obviously impact positively and lead to improvement in our current operations”
“It was a useful course and nice to have answers instead of ‘it depends’ which you often hear on courses”
“Very good presentation, a lot of very useful tips were presented”