In this analytical method transfer webinar attendees will learn the options available for the transfer of validated, non-compendial methods to a different site. In addition to current regulatory guidance, the different options for method transfer will be discussed. The webinar will set out an efficient, risk-based approach that reduces effort whilst meeting the requirements of regulators.
Why Should You Attend:
Analytical method transfer is a critical GMP activity that must be performed successfully before the receiving laboratory is considered qualified to run the method. Often, insufficient time is spent planning for method transfer and risks in the method transfer process may not have been adequately considered. This webinar will introduce the concept of quality risk management to the method transfer process. The four types of method transfer (comparative testing, covalidation, revalidation and transfer waiver) will be explained, together with considerations regarding transfer acceptance criteria. Common problems encountered during method transfer (including documentation, equipment, reagents and data processing) will be described, together with approaches to mitigate the risk of failure.
After attending this webinar, participants will be able to select the most appropriate and efficient method transfer approach for a given situation. They will also understand the potential risks involved in the method transfer process, together with the importance of identifying and mitigating them.
Areas Covered in the Webinar:
- Method transfer approaches
- Setting appropriate acceptance criteria
- Preparing for method transfer
- Is the method suitable?
- Managing risk in the method transfer process
- Common method transfer problems
- Contingency planning in the event of method transfer failure
- A risk-based approach to method transfer documentation
Who Will Benefit:
This webinar is intended for pharmaceutical scientists responsible for planning, executing or reviewing method transfer activities, including:
- Analytical development
- QC
- QA
- Regulatory affairs
