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