Risk-based Approach to Biopharmaceutical Method Transfers

Why Should You Attend:

The webinar will describe current industry practices and regulator expectations (FDA focus) and how a risk-based approach to method transfers can make transfers. A risk-based approach to method transfers maximizes probability for success while “right-sizing” size of study used to support method transfer. A risk-based approach leverages knowledge, platforms, and analytical menu to minimize size of study where appropriate. It can also minimize business risk by designing a transfer program that minimizes the chance of product failures due to bias or imprecision introduced by the transfer. This approach is easily integrated into the quality system as part of analytical lifecycle management utilizing standard risk-based procedures currently part of all Quality Systems. In addition, presenter will share 25 years of experience working at manufacturers, CMOs, and CROs to help understand the challenges of transferring methods to different types of organizations.

Presenter will bring comments from regulators and industry leaders from January 23, 2017 CMC Forum “Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry”

Areas Covered in the Webinar:

• Regulatory expectations for method transfer
• Use of a risk-based strategy for method transfer
• Fitting method transfers into the larger Quality System
• Importance of method monitoring as part of the overall transfer strategy
• Introduction of the idea of an “Analytical Target Profile” to focus thoughts on method transfer.

Who Will Benefit:

• Individuals designing method transfers
• QA
• Regulatory professionals
• Technical representatives for groups involved in method transfers
• Business leaders needing to understand business, technical risks, and needs for method transfer
• Supervisors and managers

Jeffrey Staecker
Principal Consultant, BioPhia Consulting

Jeff Staecker has worked in GMP industries for over 25 years whose experience covers a breadth of functional responsibilities (QC, QA, R & D, manufacturing) as well as working for manufacturers, a contract testing organizations, and contract manufacturing organization. Responsibilities have included oversight of groups of more than 70 individuals, large budgets, as well as individual responsibilities such as leading risk assessments, technology transfer, and consent-decree remediation activities. Jeff has had multiple roles in method transfers for more than 20 years and recently (January 23) co-chaired and presented at an international meeting “Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry” (http://www.casss.org/page/CMCJ1700).

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