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 manufacturer