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Recorded Webinar

Using Quality Indicators for Successful FDA QSR Management Reviews

timelapse 60 mins with 10-15 mins of Q and A

Note:

This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times

Speaker/Presenter

Short Abstract

Management Reviews are required by FDA’s Quality System Regulation (12CFR, Part 820). But if these reviews are to be effective they must be seen as valuable management tools by the senior management who will be conducting these reviews.

“What cannot be measured cannot be managed” is a statement many in the field of quality know. So how can this be addressed in a Management Review? The answer is Quality Indicators.

Areas Covered in the Webinar:

  • Identify the purpose of Quality Indicators
  • Management Reviews under the FDA QSR
  • Quality Indicators for Manufacturing
  • Quality Indicators for Research and Development
  • Quality Indicators for Marketing/Sales
  • Quality Indicators for Human Resources
  • How to format and report Quality Indicators
  • Linking Quality Indicators to the CAPA program
  • How to evaluate the success of the Quality Indicator programs


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