2 day in-person workshop (November 18-19, 2015)

FDA Inspections: What Regulators Expect and How to Prepare

This course is designed to provide participants with an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in pharmaceutical, biologics, and device facilities. All sessions involve case studies, examples and mock audit exercises. 

Who will benefit:

This workshop is designed for Managers, Directors, and Vice Presidents of Regulatory Affairs and Quality Assurance department working in the pharmaceutical, bio-pharmaceutical, biologics and medical device industries.

 Learning Objective:
  • To understand guidelines and practical approach of the FDA to inspections and audits
  • To develop strategies for preparing for and withstanding FDA inspections
  • To establish SOPs and policies
  • To understand how to successfully interact with FDA inspectors during visits 

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call +1 877-566-4981 or +1 410-501-5777 or email: [email protected]