What is the Essence of Quality, Beyond CAPA? Part 2

"What is the Essence of Quality, Beyond CAPA?" podcast with Dan Matlis from Axendia.
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Dan Matlis - CAPA Pt. 2

How are regulators dealing with this situation?

“Despite the slogan ‘building quality in’, most quality assessment today relies on end-product testing. This is a problem in and of itself. In addition, many of the tests methods currently being used have severe limitations in the modern, mass production environment.”

Dr. Janet Woodcock,
FDA’s Deputy Commissioner and Chief Medical Officer

• How can Life-Science organizations improve their approach to Quality? Silos need be integrated approach

  Root cause analysis based on real-time manufacturing data

  Understanding critical to quality parameters

  Tightly controlling the manufacturing process

  Shifting to building quality in rather than testing it out

• What can companies do to mitigate quality issues in manufacturing?

  Shift from CAPA to PACA

  Large windshield, small rear view mirror

  The goal should be no CAPAs

  Prevent the issues from occurring in the first place

  Control the process so that you cannot help it but make good product.

• WHITEPAPER - What is the Essence of Quality?
  www.camstar.com/CAPA