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 […]
Recent presentations from stakeholders involved in the Case For Quality regarding the Voluntary Improvement Program. https://www.youtube.com/watch?v=3rn9NlWAt7w
Members of Medical Device Innovation Consortium (MDIC)‘s Leadership Engagement Team interviewed Milan Shah from Biofourmis for the case study for Measuring Value of Quality, covering how the value of quality is measured, what is done reactively and what is done proactively, through the journey of the integration and harmonization QMS for global product launches.
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.
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
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
Two Harbors Consulting partner George Zack will present at the Greenlight Guru Virtual Summit on June 4 on the topic of performing remote or “virtual” audits as a part of the COVID 19 track. https://virtual-summit.greenlight.guru/?sc=QVIW4uUc&ac=qbB2QCbS – for more details. We hope to see you there!