This webinar presents a logical, risk-based approach to method transfer based on existing knowledge of method characteristics and effective transfer documentation. The transfer of analytical methods is an important element in the lifecycle management of active pharmaceutical ingredients and pharmaceutical products.Risks in the method transfer process should be considered and mitigated during the planning phase.However, should the method transfer fail, approaches for dealing with this eventuality are discussed. Areas Covered in the Session : Understanding method transfer Types of method transfer Comparative testing Covalidation Revalidation Transfer waiver Method transfer elements Preapproved protocol Analytical procedure Transfer report A risk-based approach to method transfer documentation to de-risk the method transfer process Dealing with method transfer failures Understand the essential elements of the method transfer process Be able to select an appropriate method transfer approach Understand how to evaluate risk in the method transfer process Have the necessary knowledge to reduce method transfer risk by reviewing method performance, writing suitable method transfer documentation and setting appropriate acceptance criteria Who Should Attend: Analytical Development Laboratory Management Quality Assurance Quality Control Staff Managing Outsourced Testing


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