How to Prepare for and Host a 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
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:
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Download Agenda- 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
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
- Regulatory management
- Engineering
- Corporate Management
- Quality Assurance/ Quality Control
- Medical Device Development/ Manufacturing