George Zack sat down with Gabor Szabo for a chat on the Case for Quality on the Critical Talks podcast.
Becky Fitzgerald, Tom Klein and George Zack got together on the Two Harbors Consulting podcast to revisit the concept of size in estimation of work and some ideas on how to approach it as an opportunity to improve. https://www.buzzsprout.com/976369/episodes/7417036 2HC episode 2 (where we originally discussed estimation and size): https://www.buzzsprout.com/976369/episodes/3325870 The CMMI Model At A Glance: https://cmmiinstitute.com/cmmi-v2-0-model-at-a-glance Let us know what you think. What questions, challenges or success stories do you have regarding estimation? What other process improvement or regulatory […]
We were very “stoked” to get a few minutes with Jon Speer of Greenlight Guru and to get his take on what we could expect to see in related to quality/regulatory in the medical device space in 2021. Hope you enjoy this episode of the Two Harbors Consulting podcast. https://twoharborsconsultingpodcast.buzzsprout.coI was very “stoked” to get a few minutes with Jon Speer of Greenlight Guru and to get his take on what we could expect to […]
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.