MedTech I.Q.

The Cutting Edge of Medical Technology Content, Community & Collaboration

Try These 3 Things When You Face an FDA Inspection

Nothing perhaps rattles a regulatory professional as much as an FDA inspection! It can send the regulatory professional who is in charge of compliance into panic mode for a variety of reasons. As the one who faces the heat from the FDA directly, the regulatory professional is answerable to the FDA, most of whose questions are challenging and awkward. If anything goes wrong at any stage, it is the company that suffers.

Yet, an FDA inspection need not be the most nerve-wracking event of a regulatory professional’s career. When the professional is armed with a proper understanding of the regulations, planning, training, and most of all, with composure, an FDA inspection need not be the terror it is thought to be.

How does a regulatory professional face an FDA inspection with calmness? This is the understanding a webinar from Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is going to give. Please visit to enroll for this session.

The three things to know when you face an FDA inspection

At this 60-minute webinar, which will be held on March 8, the highly venerated Jeff Kasoff, who is the Principal Consultant at Lean to Quality, LLC, will show how to tide over an FDA inspection without having to lose one’s nerve. The core areas that Jeff will cover at this session will include all that is needed to face an FDA inspection, including how to try these three things when you face an FDA inspection:

  • How to prepare for the inspection
  • What to do during the inspection and the close-out interview, and
  • How to respond to the inspection.

He will also give a clear understanding of 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. This understanding is necessary and important to help counter any uncomfortable situations during the inspection.

Professionals in the medical device and pharmaceutical industries will walk away with valuable information that they require to prepare for and manage FDA inspections. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.

These are the key learning areas of the webinar:

  • Types of Inspections
  • Preparation
    • Dedicated personnel for inspection
    • Facility resources to support the inspection
    • Internal audits
    • Mock audits
  • SOP for inspections
  • Behavior during inspection-what to say, what not to say
  • Inspection process
  • 483 response process

These are the questions that this webinar will help a regulatory professional face and answer:

  • 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?

This session is of immense value to those who are the frontline of facing an FDA inspection, such as:

  • Quality Auditors
  • Compliance Officers
  • Executive Management
  • Managers/Directors/Supervisors and Personnel related to:
    • Regulatory Compliance and Regulatory Affairs
    • Quality Management System
    • Quality Assurance
    • Quality Control
    • Product Development
    • Engineering
    • Manufacturing
    • Risk Management
  • Complaint Handling
  • Personnel new to the regulated industry
  • Training personnel
  • Document Control Personnel


About the speaker:

During the more than 30 years of experience in he has had in Quality and Regulatory management, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from start-up to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes.

Jeff kasoff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies.

Views: 9


You need to be a member of MedTech I.Q. to add comments!

Join MedTech I.Q.

© 2020   Created by CC-Conrad Clyburn-MedForeSight.   Powered by

Badges  |  Report an Issue  |  Terms of Service