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ISPE QM Initiative: Wave 2 Report (Download) - USD
ISPE QM Initiative: Wave 2 Report (Download) - USD
ISPE Quality Metrics Initiative: Wave 2 Report (Download Only)

The ISPE Quality Metrics Pilot Program Wave 2 Report provides a further understanding of the relationships first reported in the ISPE Quality Metrics Pilot Wave 1 Report. In the Wave 2 pilot:

  • Samples sizes increased across all technologies giving good representation in all technologies
  • More understanding of the use of process capability/performance measures was obtained
  • Quality culture was explored more deeply
  • During the planning of the Wave 2 pilot, the USFDA issued its Request for Quality Metrics FRN and Draft Guidance. The Wave 2 pilot was adjusted to include:

  • Testing the proposed FDA metrics as well as testing alternative definitions applied to the FDA Draft Guidance metrics
  • Evaluating the logistics and effort of gathering data at a product-application level
  • The ISPE Quality Metrics Pilot Program Wave 2 Report provides an in-depth understanding of:

  • Which metrics and definitions exhibited relationships with quality outcomes and which did not
  • The actual efforts required to collect FDA Draft Guidance metrics as compared to those given in the Federal Register Notice (FRN).
  • Experiential learnings and success factors to apply to your own quality metrics program
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    ISPE, in cooperation with McKinsey and Company and 21 participating companies, designed and undertook an extensive Pilot Program from 2014 to 2016 to test the feasibility of collecting and reporting a standardized set of quality metrics.

    Member Price: $ 0.00 / € 0.00
    Non Member Price: $ 99.00 / € 90.00
    Item #: QMWAVE2DLUS


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