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Validity : 14th Apr'24 to 24th Apr'24
FDA Regulations for Pharmaceutical Current Good Manufacturing Practice (cGMP)
- General information about Current Good Manufacturing Practice
- Sections of the cGMP
- Examples from Warning Letter of what not to do
Overview of the webinar
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.
Who should attend?
- All employees of pharmaceutical companies
- All employees of contract manufacturing companies for pharmaceuticals
- Anyone contemplating starting a pharmaceutical manufacturer
Why should you attend?
All pharmaceutical manufacturing and packaging companies, both over-the-counter and prescription, are subject to FDA rules for 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.
Faculty - Dr.Loren Gelber
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.