How to prepare for and host a FDA inspection and respond to 483s

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Overview: 

In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated 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, the inspection process and how to respond to 483s and warning letters.

Why You should Attend:

FDA is required to conduct an inspection every two years. A company that is prepared for the inspection 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 a Warning Letter.

Areas Covered in the Session

• Personnel preparation
• Facility needed to support inspection
• Behavior during inspection-what not to sign
• Internal/ mock audits
• 483 response 

Handout:

• FDA Inspection Readiness Checklist

• Engineering personnel
• Engineering management
• Quality Management
• Corporate Management
• Manufacturing Management
• Division management

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 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.