How To Prepare For And Host Fda Inspection And Avoid 483
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.
- Types of FDA inspections
- Inspection SOP preparation
- Preparation -people, facilities
- Mock audits
- How the inspection proceeds
- Responding to 483’s
- Personnel Preparation
- Facility Needed to Support Inspection
- Behavior During Inspection-what not to Sign
- Internal/ Mock Audits
- 483 Response
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.
- 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 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.
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