Author: George Zack
Comments regarding the MDDAP proof of concept
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
The Value of Internal ATMs on MDDAP appraisals
Mark Rutkiewicz describes the value of internal ATMs on MDDAP appraisals. @MddaProgram @caseforquality @CMMI_Institute https://www.youtube.com/watch?v=EjYIJwnSHew
What is a Lead Appraiser?
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
Two Harbors Consulting Podcast Episode 23, A conversation with Dr. Naveen Argarwal
George was invited to converse with Naveen Argarwal on a recent post he put up on Linkedin about seatbelts. They talk CAPA, risk management, quality culture, and leadership (to name a few!) https://twoharborsconsultingpodcast.buzzsprout.com/976369/12136553-2hc-ep-23-a-conversation-with-naveen-agarwal Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified […]
A chat on CAPA with Naveen Aragwal
George was invited to converse with Naveen Argarwal on a recent post he put up on Linkedin about seatbelts. They talk CAPA, risk management, quality culture, and leadership (to name a few!) https://youtu.be/DERVviyppL0 Naveen is a thought leader in medical devices. He seeks to help medical device companies build safe products through compliant risk management processes that are also highly efficient and effective. You can find him and information about his work, especially regarding risk […]
Two Harbors Consulting Podcast Episode 22
George, Tom and Becky start season 2 of the podcast. https://twoharborsconsultingpodcast.buzzsprout.com/976369/12125111-2hc-ep-22-how-about-a-season-2 Let us know what performance improvement topics you’d like us to discuss, or let us know if you’d like to come join us.
Episode 21 of the Two Harbors Consulting Podcast
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.
MDIC June 2022 Webinar re: the Case For Quality Voluntary Improvement Program
Recent presentations from stakeholders involved in the Case For Quality regarding the Voluntary Improvement Program. https://www.youtube.com/watch?v=3rn9NlWAt7w
FDA issues draft guidance for VIP
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.
