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Loren Gelber

Dr. Loren Gelber is a keynote speaker at compliance key and she has more than 40 years in the pharmaceutical industry. She spent her first ten years at FDA, followed by 20 years in Regulatory Affairs and Compliance at various pharmaceutical companies, and the last ten years as a Regulatory Compliance Consultant. During this time she was a member of various groups and committees that worked on many compliance issues. She has published a number of papers and delivered various seminars and talks. Dr. Gelber holds a BA in Biology from Brandeis University, an MS in Chemistry from Brooklyn Polytechnic Institute (now part of NYU) and a PhD in Medicinal Chemistry from Northeastern University School of Pharmacy and Allied Health Professions. She current resides in Charlotte, NC.

 Webinar Id: LSHCLG0013
12:30 PM PT | 03:30 PM ET
 Duration 60 mins

Analytical Method Validation

FDA Current Good Manufacturing Practice requirements include that validation of non-compendial analytical methods and the verification of compendial methods. The various aspects of validation or verification will be discussed, including the order in which they should be conducted and establishing specifications for success.

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       Single Attendee
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Multiple Attendee
( 2 - 5 Participants)
Corporate Attendee
( 6 - 10 Participants)
(6 months unlimited access)

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