Learn valuable insights and strategies from industry experts.
All pharmaceutical manufacturing and packaging companies, both over-the-counter and prescription, are subject to FDA rules for Current Good Manufacturing Practice (cGMP). Training in cGMP is required for all new employees on joining a pharmaceutical firm and at least yearly thereafter. The contents of this webinar can be used as part of such training, both for new employees and for a refresher for existing employees. This webinar will review all the sections of FDA cGMP regulations. Regulation text and examples from the instructor’s experience will be presented. Warning letters and inspectional observations will be used as examples of what not to do.
This training will provide valuable information to everyone who works in a pharma company. It will discuss mandatory steps that are needed to be taken to integrate an effective Good Manufacturing Practice.
This webinar is for those who work in a Pharmaceutical Industry.
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.
