FDA Process Validation Guidance

Price: $227.00
(as of Jan 13,2018 09:29:17 UTC – Details)

Get a Better Understanding of Stage 3 as Described in the FDA Process Validation Guidance

In this DVD, expert speaker Dr. Jerry Lanese, will discuss the lifecycle approach to process and test method validation. The discussion will include the differences between continuous process verification and continued process verification, but will focus on Stage 3 as described in the FDA Process Validation Guidance and the USP stimulus article. It will also offer insights on actions that an organization can take to recommendations found in the guidance documents.

Session Highlights:

FDA Process Validation Guidance with a focus on Stage 3

The USP Stimulus article in the lifecycle approach to Test Method Validation

The similarity and differences between Continued Process Verification and Continuous Process Verification

How organizations can satisfy the expectations for continued process verification

Speaker:

Dr. John G. (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.

pharmaceutical validation