Speaker Profile


Dr. Loren Gelber

Regulatory Compliance Consultant , Ex-FDA Official

Dr. Loren Gelber has more than 40 years of experience in pharmaceutical industry regulatory compliance.  She worked for about 10 years at the FDA, including as an analytical chemist and a reviewer in the Division of Generic Drugs.  As an early user of HPLC, she was involved in establishing the FDA requirements for the validation of HPLC methods, and she published the results of her validations both within FDA and externally.

Equipment Qualification and Process Validation
Equipment Qualification and Process Validation

Speaker:Dr. Loren Gelber
Time: 14th May 2019 11:30 AM PDT | 02:30 PM EDT
Duration:60 Minutes
Model : FDAQ-9260

Tue
14
May 2019

How to Prepare for FDA Inspections and Customer Audits of Pharmaceuticals
How to Prepare for FDA Inspections and Customer Audits of Pharmaceuticals

Speaker:Dr. Loren Gelber
Time: 11th June 2019 11:30 AM PDT | 02:30 PM EDT
Duration:90 Minutes
Model : PMAQ-9279

Tue
11
Jun 2019

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