FDA Inspection Preparation Guide: Handling 483s and Warning Letters

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    Speaker: Edwin Waldbusser


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    Duration: 60 Minutes
    Product Code: 50752
    Level: Intermediate

OVERVIEW

In this webinar you will learn about the types of FDA inspections, preparations such as assigning personnel to specific tasks for the inspection, facility requirements to support the inspection (front room, back room), the value of mock audits, how personnel should conduct themselves during the inspection, the inspection process and responding to 483s and FDA warning letter.

How to respond and when is critically important.

Also covered will be the FDA’s rights during the inspection and documentation you are not required to show them.

WHY SHOULD YOU ATTEND

FDA is required to conduct an inspection every two years. A company that is prepared for FDA audits is less likely to receive 483’s than a disorganized company.

If a 483 is received knowing how to respond will lessen chances of receiving an FDA warning letter.

AREAS COVERED

  • Personnel preparation
  • Procedure to follow during FDA audits - what to do/ what not to do
  • Facility requirements to support FDA inspection
  • Behavior during inspection-what not to sign
  • Internal/ mock audits
  • 483s/ FDA Warning Letter response

LEARNING OBJECTIVES

Learn how to be always prepared for FDA inspections and how to handle 483s and FDA warning letter. Also understand the significance of mock audits.

WHO WILL BENEFIT

  • Engineering personnel
  • Engineering management
  • Quality/ regulatory Management
  • Corporate Management
  • Manufacturing Management
  • Division management
  • Legal counsel

SPEAKER

Years of Experience: 30+ years

Areas of Expertise: Design Control, Risk Analysis and Software Validation of Medical Devices

Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 9 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

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