8 Key Steps to Managing Quality Events

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Strong quality systems are required to maintain a successful business and avoid 483’s from FDA inspections. A common cause for citations in industry come from the management of quality events. Here are the basic elements in any quality event management process:

  • Detection
  • Categorization
  • Root Cause Investigations
  • Immediate Corrective Action
  • Impact Assessment (quality and safety)
  • Corrective and Preventative Actions
  • Effectiveness Checks
  • Closure, Trending, and Analysis

If you need help establishing a quality events management system, Pharmatech Associates can help! Contact us today to learn more.

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