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Site language : English - Français
Ref : 26431
Event :FDA Process Analytical Method Validation

Date :Friday March 09th, 2018

Location :Online (Internet, Videoconferencing, ...)

Type :Education - International audience

Accreditation :--


Further information

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
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

Further information

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Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All [...]

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FDA Process Analytical Method Validation Medicine - Pharmacy
Professionals, Healthcare, Medical, Online Trainings, Safety courses
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