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Presenter : Edwin Waldbusser


  • Date: 8/25/2020 01:00 PM - 8/25/2020 02:00 PM
  • Location: Online Event

Description

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.

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

Who Should Attend:

  • Quality Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Corporate Management
  • Division Management