An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry.
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.
Areas Covered in the Session:
FDA System Based Inspection Guidance
Laboratory Control System
Most common observations in the laboratory
Warning letter observations and analysis
Who Will Benefit:
Quality Control Manager
Analysis and Microbiologists
John (Jerry) Lanese is an independent consultant with a focus on Laboratory Controls, Quality Systems and the components of an effective Quality System as they apply to the pharmaceutical and medical device industries and their suppliers to those industries. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan.
Event Fee: One Dial-in One Attendee Price: US$150.00