How to prepare for and host a FDA inspection and respond to 483’s
- Speaker:Edwin Waldbusser
- Product Code:GRC-90197
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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
- FDA Inspection Readiness Checklist
- Engineering personnel
- Engineering management
- Quality Management
- Corporate Management
- Manufacturing Management
- Division management