How to prepare for and Host FDA Inspection and Avoid 483's
Duration: 60 Minutes
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.
Objectives of the Presentation
Why Should you Attend
- Types of FDA inspections
- Inspection SOP preparation
- Preparation -people, facilities
- Mock audits
- How the inspection proceeds
- Responding to 483's
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.
Who will Benefit
This webinar will provide valuable assistance to all personnel in:
- Regulatory management
- Corporate Management
- Quality Assurance/ Quality Control
- Medical Device Development/ Manufacturing