https://www.youtube.com/watch?v=2O3NAzfqiBg Check out this webinar that provides an introduction to the Accelerate Sustainable Capability pilot. Let me know if you have questions or are interested in possibly participating in the pilot.
Next Two Harbors Consulting podcast is up – “You had an appraisal (or an audit) – now what?” https://twoharborsconsultingpodcast.buzzsprout.com/976369/6184336-2hc-ep-12-you-had-an-an-appraisal-now-what George is joined by Becky and Tom to discuss what happens after an organization has had an appraisal. Now that you have results, what do should you do with those to get the most value of them? Are you enjoying this podcast? If so, please share it with a colleague! We’d love to have more people […]
Episode 11 of the Two Harbors Consulting podcast – a recording of our “Ask an Appraiser Anything” October 2020 Webinar. Hope you enjoy it! https://twoharborsconsultingpodcast.buzzsprout.com/976369/5891494-2hc-ep-11-ask-an-appraiser-anything-october-2020-webinarEpisode 11 of the Two Harbors Consulting podcast – a recording of our “Ask an Appraiser Anything” October 2020 Webinar. Hope you enjoy it! https://twoharborsconsultingpodcast.buzzsprout.com/976369/5891494-2hc-ep-11-ask-an-appraiser-anything-october-2020-webinar
Case for Quality becomes a Collaborative Community Announcement. Case for Quality becomes a collaborative community with FDA – @MddaProgram @caseforquality https://www.businesswire.com/news/home/20201007005846/en/The-Medical-Device-Innovation-Consortium-MDIC-Announces-Case-for-Quality-Collaborative-Community-with-FDA-Participation
Mary Lynn Penn, the president of Performance and Methods Consulting joins us this week on the Two Harbors Consulting Lynn is involved in CMM everywhere – from executing appraisals, to being on working groups to help define the next revision of the Model, to chairing Capability Counts Conference – Lynn is there! We chat Lynn’s career history, the Model, appraisals and getting value add, the PAB, maturity and capability levels, and CMMC. Hope you enjoy this […]
Miss any part of REDi? Check it out at sbiaevents.com/redi2020/#files – in particular check out the latest on @caseforquality with an update from @CiscoVicenty from the @FDADeviceInfo at: concerted.adobeconnect.com/ps5q89fqn008/ – updates on @mddap, MDIAS, #makecapacool, Advanced Manufacturing and ASC. Looking for an update on the @MddaProgram? Be sure to checkout the @caseforquality session from @MDIConline with @CMMI_Institute ‘s @KimKaplan_US and @FDADeviceInfo @CiscoVicenty in this update: https://www.youtube.com/watch?v=NcjaaixzWqg
Excited to see the announcement of enrollment for this program https://mdic.org/project/case-for-quality-accelerate-sustainable-capability-pilot/ from MDIC and the announcement from FDA: https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/accelerate-sustainable-capability-asc-pilot-study Let us know if you have any questions.
A brief webinar (22min) providing a very high level overview of some of the changes between CMMI 1.3 and 2.0 – https://www.youtube.com/watch?v=oh5kNP9JlW0
ISACA Chief Architect, Ron Lear and CMMC Board Member, Jeff Dalton join George Zack of Two Harbors Consulting to discuss the current state of CMMC, where it connects with CMMI and where it looks to be going in the future. We hope you find this conversation to be informative. https://twoharborsconsultingpodcast.buzzsprout.com/976369/4701203-2hc-ep-9-jeff-dalton-and-ron-lear-discuss-the-cmmc-and-cmmi Follow Ron at his CMMI Institute blog at: https://cmmiinstitute.com/news/blogFollow Jeff at his Linkedin at https://www.linkedin.com/in/jeffdalton/ or his Twitter at https://twitter.com/CMMIAppraiser
Read about how a regulated medical device manufacturer leveraged the CMMI Framework to reduce complaint cycle time. Let us know if you have questions or want to discuss further this innovative program! https://cmmiinstitute.com/getattachment/8069a72b-4d4f-491b-9739-ec6edb71e79a/attachment.aspx