How to Withstand an FDA Audit of your Facility April 11, 2013

This training on managing FDA audits will discuss practical tips to be prepared for an FDA audit of your facility, the appropriate conduct during an audit and the follow-up activities to an audit. You will learn the Do’s and Don’ts of an FDA inspection to ensure a successful audit.

Why Should You Attend:

If your company is marketing a product or service that is regulated by the FDA, you should be prepared for an FDA audit. If you have never been audited by the FDA or if you were last audited 4-6 years ago, if any product or service you offer has been in the news – positive or negative, or if you are getting ready to submit a clinical trial or marketing approval application, chances are you would get audited by the FDA in the near future. Although different facilities are subject to different regulations, FDA auditors follow some general guidelines that are common across all.

Attend this FDA audit webinar to understand the general rules and know through specific case studies , the common themes and differences across facilities subject to GCP, GMP or GLP regulations. We will also discuss ways to be prepared for an FDA audit, conduct during an audit, and follow-up activities to an audit. It will help you convert an FDA audit into an opportunity to demonstrate high quality products and services, and to increase credibility in the industry for your company.

Learning Objectives:

- GCP/GMP/GLP requirements. Why inspections are conducted and by what statutory authority?
- Reasons for FDA conducting an inspection.
- What to expect from an audit? What is subject to FDA purview and what's off-limits?
- Preparing for the inspection/Audit - What you need to know and do to prepare for, during and even after the inspection, a ctions to be taken upon the investigator's arrival, required documentation, Individual responsibilities for the inspection.
- Do's and don'ts of an FDA audit/Inspection.
- Following up on the audit - What to do next? How to respond to findings and facilitating the documentation and remediation process…and reaching final closure?