Technology Transfer of Pharmaceutical Products

1 Day/s

CPD Hours: 7

Classroom, in-house

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.

Suitability This course is suitable for TT project managers, scientists, engineers or other disciplines working in laboratory, production and QC roles. It is applicable to those both on sending sites and receiving sites.
The course includes the following topics and reinforced using group exercises:

  • Regulatory/industry Background
  • Stages of a TT + Project Management
  • Product & Process understanding
  • Risk Management for TT
  • Analytical methods transfer, including case studies
  • Success criteria & TT
  • Your Action Plan

    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:

    • Understand the stages for transfer and the regulations that govern them
    • Know the responsibilities of sending and receiving sites
    • Appreciate the application of risk management to TT
    • Be able to design control strategies that enable successful transfers
    • Have criteria for measuring success between Sending and Receiving Units

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Meet the tutors

Bruce Davis

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.

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