FDA Process Analytical Method Validation

Overview:

• 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
• Supervisors
• Analysis and Microbiologists

Speaker Profile:
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

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

Others Details

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