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CPD Hours: 7
Technology Transfer (TT) is a critical task in the increasingly global and collaborative pharmaceutical industry. To succeed in this interconnected world, companies must seamlessly transfer active pharmaceutical ingredients, finished dosage forms and analytical methods between in-house and third-party development and manufacturing sites around the world. Such transfers often involve multiple processes shaped by different national and organisational cultures, potentially creating scope for damaging delays that may impact operations, procedures, facilities, methods and a host of other related areas.
TT often has regulatory implications too. Successful completion of this course will equip individuals with an understanding of how these and other factors may affect the TT process, including the importance of control strategies to enable successful transfers to be executed to meet predefined criteria. The course features presentations, exercises and case studies, including content from RSSL’s own analytical lab experiences, to facilitate participant learning.
Successful completion of this course will equip individuals with an understanding of how these and other factors affect the TT process and the steps to execute transfers to meet predefined criteria for a positive outcome. By the end of this course you will:
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
Bruce Davis carries out training and consultancy in a number of science and risk-based topic areassuch as Quality Risk Management (QRM); Quality by Design (QbD); Process validation/ qualification; Technology transfer.
He is an experienced trainer with many years’ experience of the pharmaceutical industry. He tries to ensure participants have an engaging and learning training experience. He has always been interested in the importance of having a patient and science and risk-based approach and in its application during training.
He runs his own consultancy business and has done for the past 11 years. He formerly worked at AstraZeneca, where he had an international engineering role, being responsible for putting in place new manufacturing and development facilities. He is past chair of ISPE and has contributed to or colead a number of their industry guides, including Technology Transfer, Process Validation, and a chapter on ATMPs.
Quality risk management - how to apply ICH Q9 in practice
This one day course provides the delegate with understanding of the principles of and practical application Quality Risk Management (QRM).