How to Prepare for and Host FDA Inspection and Avoid 483s
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.
Why Should You Attend:
Although the 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 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 in the Session:
- Types of FDA inspections
- Inspection SOP preparation
- Preparation -people, facilities
- Mock audits
- How the inspection proceeds
- Responding to 483s
Who will Benefit:
- Regulatory Management
- Corporate Management
- Quality Assurance/ Quality Control
- Medical Device Development/ Manufacturing
Edwin Waldbusser is a consultant retired from the industry after 20 years in management of the development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis, and software validation for the past 8 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.