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.
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.
Areas Covered in the Session :
- General information about Current Good Manufacturing Practice
- Sections of the cGMP
- Examples from Warning Letter 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 manufacture
Course Director: DR. LOREN GELBER
Dr. Loren Gelber has more than 40 years of experience in pharmaceutical industry regulatory compliance. She worked for about 10 years at the FDA, including as a reviewer in the Division of Generic Drugs. She then transitioned to industry, working for four different pharmaceutical companies. For the last 13 years she has been a regulatory compliance consultant, both for consulting companies and independently.