ComplianceOnline

Expert Profile


Loren Gelber
Regulatory Compliance Consultant , Ex-FDA Official

Dr. Loren Gelber 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.

Trainings by Expert

OTC Drug Regulations
Category: Drugs and Chemicals (Pharma) , GXP Pharmaceutical , Drug Marketing Compliance , Quality and Safety , Drugs Regulations , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Regulatory Affairs , Documentation and Data Management , QA/QC , Sales and Marketing

Prescription and OTC GMP Training
Category: Drugs and Chemicals (Pharma)

Analytical Method Validation Best Practices for Pharma Companies
Category: Drugs and Chemicals (Pharma)

How to Prepare for an FDA Inspection?
Category: All FDA Regulated Industry

Toxic Impurities in Active Pharmaceutical Ingredients
Category: All FDA Regulated Industry

FDA Regulatory Inspection and Audit Training: Pack of 6 Training Courses
Category: All FDA Regulated Industry