International conference details
FDA Process Analytical Method Validation
Fremont (United States), 9 March 2018
Domain:
Key deadlines
- Conference starts:
- 2018-03-09
Website
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
18004479407 161 Mission Falls Lane, Suite 216,,
Fremont 94539 (United States)