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Réf : 25119
Evènement :Analytical Method Validation in FDA process - 2017

Date :Mardi 25 Avril 2017

Lieu :En ligne (Internet, Visioconférence, ...)

Type :Formation - Audience Internationale

Accréditation :--


 

Informations

Overview:  
An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.
 
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 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.
 
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
Full Details & Registration Link:
http://www.compliance4all.com/control/w_product/~product_id=501215LIVE?channel=mailer&camp=Webinar&AdGroup=doctorama_Apr_2017_SEO

Renseignements

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Annonceur

Compliance4All
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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Précisions

Analytical Method Validation in FDA process - 2017 Médecine - Sécurité sociale - Santé Publique - Médecine interne - Médecine générale
pharmaceutical, medical device compliance webinar, medical device calibration requirements, pharmaceutical manufacturing, largest pharmaceutical companies, fda compliance guidelines, analytical method validation, method validation
Professionnels, Pharmaceutical, Medical device compliance webinar, Medical device calibration requirements, Pharmaceutical manufacturing, Largest pharmaceutical companies, Fda compliance guidelines, Analytical Method Validation, Method validation
100 1 --
English

Divers

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