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Dr.Loren Gelber
Area Of Expertise : Pharmaceutical
40 Years Of Experience
Training Industry : Life Sciences
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.
2 results Found
Recorded Webinar
Equipment Qualification and Process Validation
FDA current Good Manufacturing Practice (GMP) regulations require that all equipment be qualified and all manufacturing processes, including equipment cleaning processes, be validated. These qualifications and validations must be repeated if changes are made o ...
- Intermediate
- 90 Mins
On-Demand Webinar
Cannabinoids as Drugs
This webinar will discuss the current status of cannabinoids as medical products in the United States. The focus will be on what we can learn from the FDA approval of Epidolex (Cannabidiol) oral solution 100 mg/mL. How to obtain research information will be pr ...
- Basic & Intermediate & Advanced
- 90 Mins