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3 modules8 lessons~6 h

Facing USFDA Audits as a Microbiologist

What inspectors look for in the micro lab, and how to answer them.

What you'll be able to do

  • ✓ Prepare the micro lab for a regulatory inspection
  • ✓ Answer inspector questions clearly and safely
  • ✓ Defend investigations and invalidations with evidence
  • ✓ Recognise and fix common 483 themes before an inspection

Syllabus

  1. MODULE 1Inspection basicsHow inspectors think.
  2. MODULE 2Area by areaEM, sterility, water, data integrity.
    • Defending EM data and excursions
    • Sterility positives and invalidations
    • Data integrity under the microscope
    • Water systems and objectionable organisms
  3. MODULE 3After the inspection483 responses and CAPA.
    • Writing a 483 response
    • Final exam

Questions

Is this only for FDA?

FDA is the focus, but the same principles apply to EU, WHO and other inspections.

Do I need experience?

Some QC experience helps; freshers will still learn how labs are judged.