Now is your chance to be heard!  The FDA recently released a draft proposal: Request for Quality Metrics- Guidance for IndustryThis is an important document that could affect the way your organization gathers data.

The FDA’s guidance describes much of their initial thoughts on Quality Metrics in terms of utility, construct, operationalization, and consequences, and there are some areas where their thoughts have evolved. For example, the guidance suggests that both process capability and culture metrics should now be “optional.”

ISPE has been at the forefront of gathering clear and objective data through its Quality Metrics Pilot Program- Wave 1. Our 2014 pilot mirrored many of the proposed metrics within the new FDA draft guidance.

As we plan for Wave 2 of the program, we have the opportunity to focus even more on these proposals and provide more supportive guidance to the industry. In addition to submitting your comments on the FDA guidance, ISPE encourages you and your company to participate in our Wave 2 Quality Metrics Initiative.

As an ISPE member, you have the power to join in the creation of important regulations and guidelines. Regulatory agencies like the FDA look to ISPE for input on their latest developments, and ISPE looks to our members to help us provide the best feedback possible.

Click here to submit your comments on the FDA Quality Metrics Guidance by 14 August.

 

 

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