Loren Gelber
Pharmaceutical consultant Independent
Dr. Loren Gelber is currently an independent consultant, based in Charlotte, NC.She previously was employed by Akesis, Bestsweet, RRI, Andrx, Royce, Universal Research, Danbury Pharmacal, Barr and the US FDA. She has been in Regulatory Compliance, Regulatory Affairs, Clinical Research and Quality Control Laboratories.

Dr. Gelber has a Ph.D. in Medicinal Chemistry from Northeastern University, a Masters in Chemistry from Brooklyn Polytechnic and a Bachelors in Biology from Brandeis University.
Upcoming Webinar
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Recorded Webinar
Cannabinoids as Drugs - Latest Updates
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 presented. The current market for Cannabidiol (CBD) in the United States will also be discussed. This information may be useful in predicting the future of cannabinoids in the United States. The legality of foods containing CBD will be considered.
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Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations
This webinar will provide attendees with the knowledge and skills needed to develop and produce an OTC drug product for marketing and sale in the U.S.
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How to Prepare for FDA Inspections and Customer Audits of Pharmaceuticals
This webinar will include things that it is important to know about FDA inspections. Using the self-auditing process to correct problems before the FDA or customer arrives will be discussed. How to prepare for an FDA inspection and how to behave during one will be reviewed. The usefulness of mock inspections and other practice routines will be considered. How to respond to FDA inspectional observations (FDA form 483) and customer observations will also be discussed. How to avoid FDA Warning Letters, and when it is possible to do so, will be reviewed.
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Equipment Qualification and Process Validation
This equipment qualification and validation webinar will help you to understand the various processes of equipment qualifications (IQ, OQ & PQ) and process validation steps (when, what and how to tests) in a manufacturing process. It will also highlight all the requirements of FDA cGMP regulations that all equipment to be qualified and all manufacturing processes to be validated if problems are encountered changes have to be made periodically as necessary.
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Prescription and Over-the-Counter GMPs: Avoiding FDA Form 483 and Making the Best Decisions
In many countries around the globe, certain medicines with a long history of use are allowed to be sold over the counter (OTC) at certain doses without a prescription. So the safety and efficacy are well known from a public health/patient safety perspective, a contaminated OTC medicine could potentially impact a larger user population than a prescription medicine. In some countries, OTC manufacturers are treated the same way as other drug manufacturers - their products are after all medicines and are inspected to the same standards and at the same frequencies. In the U.S., OTC manufacturers must meet 21 CFR 210/211 and current good manufacturing practices (cGMPs).
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