FDA CGMP Regulations for Pharmaceuticals
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.
- What is CGMP?
- Why does it apply to me?
- What are the main sections of the CGMP?
- What not to do?
- General information about Current Good Manufacturing Practice
- Sections of the cGMP
- Quality control group
- Personnel qualifications
- Buildings and facilities
- Equipment
- Control of components, containers, and closures
- Production and process controls
- Packaging and labeling control
- Holding and distribution
- Laboratory controls
- Records and reports
- Returned and salvaged product
- Examples from warning letter 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.
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