Technology Transfer

Session Type: Recorded: Recorded Webinars
Knowledge Element: Product Development
Speaker: Charles F. Carney, Seraphim Life Sciences Consultants LLC
Duration: 30 minutes

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Knowledge and understanding of a manufacturing process, either for active pharmaceutical ingredient (API) or finished medicinal product, and all of the associated analytical procedures must be transferred during the product life cycle. Such transfers may occur because a larger scale is needed for manufacturing, suitable capacity does not exist in the developing function, the product is approved for sale and must be produced in the commercial facility or the product is so successful that it must be produced in more than one facility. Every company should anticipate the need for any or all of these possibilities and have a systematic way to capture and collate all critical information to pass on to the next manufacturing site.

This seminar will provide an overview of the information and data that need to be known and collated in order to transfer manufacturing process for API or Drug Product and to transfer Analytical Procedures specific for each of these materials. It will describe a team approach which can ensure that all parties in the sending and receiving sites will be involved and engaged in the process for successful transfer of manufacturing and testing procedures. It will also provide descriptions of the differences that one might expect when transferring within a company as compared to transferring between two companies. References to regulatory guidance which can help in the establishment of processes and in the expectations of regulatory review groups will also be given.

Learning Objectives:

• The concept of design space for pharmaceutical products
• The types of information and data that are important for the definition of design space and how they can be collected during development
• Contrasts in the types of information that must be gathered for small molecular weight synthetic compounds as compared to high molecular weight compounds produced through biological processes
• The process for setting specifications for materials and for establishing success criteria for technology transfer processes
• The importance of risk assessment in technology transfer and the establishment of the risk minimization action plan by the team of operating personnel from the giving and receiving operations

Who should attend:

• Pharmaceutical product development professionals who will develop syntheses for active pharmaceutical ingredients or formulation and manufacturing processes for new medicinal products and will participate in the transfer of this knowledge to their counterparts in other organizations
• Pharmaceutical operations professionals either for active pharmaceutical ingredients synthesis or medicinal product manufacture who will receive technology information for active pharmaceutical ingredients synthesis or medicinal product manufacturing and must assimilate it into their operations effectively
• Other pharmaceutical professionals who want an overview of the breadth of issues involved in technology transfer for active pharmaceutical ingredients and medicinal products

Speaker Biography

Charles Carney has nearly 40 years of experience in pharmaceutical drug product development, manufacturing, and analytical control. For the last 15 years of his corporate service he was the associate director of investigational supplies in the Connecticut R&D Center of Boehringer Ingelheim. Since 2003 he has been a consultant for Seraphim Life Sciences Consulting, LLC. His responsibilities have included performing and managing pharmaceutical, analytical, and GMP compliance aspects of drug product development, including the outsourcing, validation, and technology transfer aspects and the quality control, and facility design for commercial drug products. He is a co-editor of the second edition of “Drug Products for Clinical Trials.”

What is a Recorded Webinar?

Previously held webinars are available as recorded sessions, which you can view at your convenience. Registration orders are processed within two business days, after which participants will receive an e-mail confirmation with a link to the Recorded Webinar. After receiving the link to the Recorded Webinar, you have 15 days to view it.

What are CPIP^SM Recorded Webinars?

CPIP^SM Recorded Webinars are a group of Recorded Webinarswas developed to help individuals in preparation for the Certified Pharmaceutical Industry Professional^SM (CPIP^SM) examination..

The Certified Pharmaceutical Industry Professional^SM (CPIP^SM) credential recognizes “change agents” as the necessary ingredient to foster industry innovation and enhance drug product quality. The credential establishes a global competency standard for industry professionals, and candidates are assessed through demonstrated education, experience, and a rigorous examination. Completion of any of these seminars does not guarantee successful completion of the CPIP certification exam, and these seminars do not include every subject to the depth of what will be covered on the CPIP exam.

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