How to Prepare for and Host a FDA Inspection and Avoid 483's

Duration: 60 Minutes
flat 50% off on this webinar
In this webinar you will learn about the types of FDA inspections, necessary preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection, the value of mock audits, how company personnel should conduct themselves during the inspection, how the inspection will unfold and how to respond to 483's.
How to Avoid 483’s
Instructor: Edwin Waldbusser
Product ID: 502525
Objectives of the Presentation
  • 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
Why Should you Attend
Although FDA is strapped with limited resources and competing priorities, the agency continues to hammer regulated companies with FDA 483 inspection observations and Warning Letters.

In 2014 alone, FDA conducted more than 38,000 inspections and issued 8,457 Form 483s—inspection observations that, in the inspector's judgment, indicated an operation or product violated FDA requirements. Attend this training to learn, if a 483 is received knowing how to respond will lessen chances of receiving the FDA Warning Letter.

Areas Covered
Topics covered include:
  • Types of FDA inspections
  • Inspection SOP preparation
  • Preparation –people, facilities
  • Mock audits
  • How the inspection proceeds
  • Responding to 483's
Who will Benefit
  • Regulatory management
  • Engineering
  • Corporate Management
  • Quality Assurance/ Quality Control
  • Medical Device Development/ Manufacturing
$375
Recorded Session for one participant
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/non-conforming product programs. He now consults in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis.

Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.
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