FDA Process Analytical Method Validation

Fremont (United States), 9 March 2018


Key deadlines
Conference starts:
2018-03-09
Website

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Conference Description

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: support@compliance4All.com

Conference creator: compliance4all

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Conference Location

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18004479407 161 Mission Falls Lane, Suite 216,,
Fremont 94539 (United States)

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