CMMI

Two Harbors Consulting Podcast Episode 14 – revisiting size

Posted on

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 […]

Case for Quality

2HC Podcast Episode 13: A Conversation with Jon Speer

Posted on

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 […]

Case for Quality

Episode 12 of the Two Harbors Consulting Podcast “You had an appraisal, now what?”

Posted on

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 […]

CMMI

Two Harbors Consulting Podcast Ep. 11 – Ask an Appraiser Anything October 2020 Webinar

Posted on

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

Uncategorized

Case for Quality becomes a Collaborative Community

Posted on

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

CMMI

Episode 10 of the Two Harbors Consulting Podcast: a conversation with Lynn Penn

Posted on

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 […]

MDDAP

Recent Webinars on Case for Quality

Posted on

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