Guidelines for New FDA Transfer of Analytical Methods - 2017

When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'.

Areas Covered in the Session:

• Four approaches for analytical method transfer and testing
• Responsibilities of the transferring and receiving laboratory
• Developing a transfer plan and a pre-approval protocol

Who Will Benefit:

• Analysts
• Lab Supervisors and Managers
• QA Managers and Personnel
• Consultants
• Teachers