Some comments from Becky Fitzgerald at Two Harbors Consulting and Mark Rutkiewicz at Innovize regarding their MDDAP case study including their initial involvement in the program’s proof of concept. https://www.youtube.com/watch?v=giyaCzPYPpQ
Mark Rutkiewicz describes the value of internal ATMs on MDDAP appraisals. @MddaProgram @caseforquality @CMMI_Institute https://www.youtube.com/watch?v=EjYIJwnSHew
Two Harbors Consulting colleague Becky Fitzgerald answers the question what a CMMI Lead Appraiser is and what value they offer. https://www.youtube.com/watch?v=B543NvLv8bA
It has been a minute but … Lynn Penn joined us for a few minutes to discuss some aspects of CMMI appraisal interviews. https://twoharborsconsultingpodcast.buzzsprout.com/976369/11387815-2hc-ep-21-mddap-interviews We’d love your feedback on this and what other topics you’d like to see covered in the ‘cast.
Recent presentations from stakeholders involved in the Case For Quality regarding the Voluntary Improvement Program. https://www.youtube.com/watch?v=3rn9NlWAt7w
Long awaited draft guidance for the Voluntary Improvement Program: https://www.fda.gov/media/158180/download Let us know what you think (in addition to submitting your comments to the docket). Kudos to all (you know who you are) that made this happen over the last handful of years. Thank you for your time, effort, and continuous improvement thinking.
An instructional video regarding the performance report from @CMMI_Institute
A new case study posted by CMMI regarding the Medical Device Discovery Appraisal Program (@MDDAP) and the success Edwards Lifesciences has seen in the program. Let us know if you have any questions or want to discuss this innovative program. https://www.isaca.org/enterprise/medical-device-discovery-appraisal-program
Becky and George sit down with Paul Kimmerly as our guest where discuss the ATL observation process (using George’s recent one as the context example). https://twoharborsconsultingpodcast.buzzsprout.com/976369/9493959-2hc-ep-19-paul-kimmerly-and-the-lead-appraiser-observation-process If you are up for it, give it a listen and let us know what you think.