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.
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 Quality
Systems and the components of an effective Quality System. He received a
BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from
the University of Michigan and began his career teaching Analytical Chemistry
in a small liberal arts college. Dr. Lanese moved from the academic
environment to the pharmaceutical industry where he has managed Analytical
Research, Quality Control and Quality Assurance functions.
Compliance4All DBA NetZealous,