FDA Inspections – Do's and Don'ts

September 25, 2015 - Fremont CA US

Compliance4all

support@compliance4All.com
Phone:8004479407
Fax:302-288-6884

Overview: Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act which are codified in Title 21 of the United States Code. However, the language in the law and regulations is often very vague and difficult to interpret. Hence, FDA inspections often result in observations and compliance actions that cost manufacturers and marketers of FDA regulated products hundreds of hours and sometimes millions of dollars to address to the satisfaction of the agency. Why should you Attend: If you are looking for answers to these questions, you would certainly benefit by attending this seminar on managing FDA inspections: How can your company be prepared for an FDA inspection? How should your company respond to a 483 or warning letter correctly the first time without hiring a costly law firm? What can an FDA inspector legally ask for during an inspection and what can you refuse to show the investigator? Well, the answers to these and many, many more typical questions are now available in a simple to understand yet detailed training session designed to help manufacturers of FDA regulated products prepare for, manage, and follow up on inspections. Compliance4All Adam Fleaming Phone: +1-800-447-9407 support@compliance4all.com www.compliance4all.com

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