ComplianceOnline

The FDA Inspection: Preparation, Management, and Follow-Up

Instructor: Jeff Kasoff
Product ID: 701568
Training Level: Intermediate to Advanced
  • Duration: 60 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$299.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This course will discuss the limitations of FDA’s scope during an inspection, and best practices for preparing for an inspection and what to do during a close-out interview. It will also list FDA guidance documents used by inspectors during inspections.

Why You Should Attend:

  • Does the FDA call in advance or just show up at my door?
  • Where do I let the inspector go?
  • Do I give them a tour?
  • What should I let them see?
  • Who should I let them talk to?
  • Are they ever going to leave?

An FDA inspection can be a nerve-wracking experience for a regulatory professional. However, adequate planning, training, composure, and understanding are all you need to ensure a positive outcome. This course will address all the above frequently asked questions when it comes to FDA inspections and offer guidance from the expert’s practical experience.

This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. The session will also illustrate the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.

Areas Covered in the Webinar:

  • How to prepare for an FDA inspection.
  • Development and contents of an SOP for FDA inspection.
  • Personnel training before inspection.
  • How to behave during an inspection.
  • Limitations of scope of inspection.
  • Response to investigation findings.
  • FDA guidance documents used by their inspectors.

Who Will Benefit:

This webinar will provide valuable assistance to all companies in the medical device, diagnostic, pharmaceutical, and biologics fields that market in the U.S. since they are by definition subject to FDA regulations. The employees who will benefit include:

  • Executive/senior management
  • Regulatory management
  • QA management
  • Any personnel who may have direct interaction with FDA officials
  • Consultants
  • Quality system auditors

Instructor Profile:

Jeff Kasoff RAC, is the director of quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Mr. Kasoff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For 13 years prior to that, he served as director of regulatory affairs at Life-Tech, Inc., in which capacity he was similarly responsible for quality system oversight. Mr. Kasoff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. He received his Regulatory Affairs Certification in 1996.

Follow us :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
ComplianceOnline Medical Device Summit 2017

Product Reviews Write review

I attended the Best Practices for FDA Inspection webinar today. It was very informative and have already begun working on a FDA Inspection SOP as a result.
- Anonymous

Best Sellers
You Recently Viewed
    Loading