Could you be ready for an FDA inspection tomorrow?
If the thought makes you break out in a cold sweat, this fundamentals webinar with a former FDA inspection official is for you.
David L. Chesney, principal and general manager of DL Chesney Consulting, is a 23-year veteran of the FDA Office of Regulatory Affairs’ field inspection and enforcement operation. He’ll explain everything you need to know about inspection management so you’ll be prepared when the FDA arrives.
You’ll come away understanding the agency’s authority and rights under the law as well as your company’s rights, the general process for conducting an inspection, key resources on the FDA website to help you get prepared, what will trigger an FDA Form 483 (and effective ways to respond to one!) and problems and pitfalls to avoid in inspection management and post-inspection correspondence and meetings.
Mr. Chesney — who served as an FDA investigator, supervisory investigator, director of investigations and district director in four different FDA districts — will empower you to increase your inspection success.
- What the FDA must do to conduct an inspection lawfully
- What the FDA may not do — by law — during an inspection
- What an FDA Form 483 is and what may trigger its issuance, plus how to respond effectively if you receive one
- The enforcement options the FDA can use and the risks each present to your company
- Which resources are most useful to obtain from the FDA website to aid your inspection preparation and management efforts
If you want to facilitate a successful inspection — while easing anxiety and effort — this webinar by a former FDAer is a must.
Who Will Benefit:
- Quality assurance professionals
- Quality control professionals
- GXP auditing and inspection hosting personnel
- Regulatory affairs professionals
- Manufacturing personnel and laboratory analysts
- In-house counsel
- Consultants who assist companies with FDA inspection readiness and GXP compliance