An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.
Why should you Attend: Observations that test methods are inadequate or the firm does not have appropriate data that demonstrates the method performs as intended rank high on the list of observations in the laboratory. It is important that all analysts, method developers as well as the Quality Control analysts, understand the requirements for analytical method validation and the implications of the characteristics that must be considered for Analytical method validation.
A recent USP Stimulus Paper demonstrated the importance of identifying the Analytical Target Profile. This stimulus paper and the 2011 FDA guidance on process validation emphasize the importance of a clear understanding of the Analytical Target Profile early in the test method lifecycle and make it clear that test method developers and quality control laboratories must demonstrate that the test method continually performs as intended throughout the method lifecycle. This webinar will discuss method validation requirements through the test method lifecycle: method development, the formal method validation and continued use of the method for routine testing.
Areas Covered in the Session:
FDA System Based Inspection Guidance
Laboratory Control System
Most common observations in the laboratory
Warning letter observations and analysis
- Quality Control Manager
- Analysis and Microbiologists
• Quality Control Manager
• Analysis and Microbiologists