16 episodes

The team at Two Harbors connect with each other and guests to discuss topics related to process improvement, business results, the CMMI Model and other related information. Contact them at twoharborsconsulting.com or info@twohc.com

Two Harbors Consulting Podcast Two Harbors Consulting LLC

    • Business

The team at Two Harbors connect with each other and guests to discuss topics related to process improvement, business results, the CMMI Model and other related information. Contact them at twoharborsconsulting.com or info@twohc.com

    2HC ep 16: Are there core practice areas in the CMMI model?

    2HC ep 16: Are there core practice areas in the CMMI model?

    George, Becky and Tom get together and discuss an idea that GZ has about the CMMI Model - that there are five (well, and maybe 2 or 3 more) practice areas that are more foundational to the model and really shouldn't be skipped over.   Listen in to hear what those practice areas are and the discussion surrounding this topic.  

    Let us know what you think.  What questions, challenges or success stories do you have?  What other process improvement or regulatory topics you'd like to have covered in future podcasts?  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com.  

    Becky Fitzgerald:  becky.fitzgerald@twohc.com
    Tom Klein tom.klein@twohc.com
    George Zack george.zack@twohc.com

    • 39 min
    2HC ep 15: Where has the 2HC podcast been?!

    2HC ep 15: Where has the 2HC podcast been?!

    Becky, Tom and George get together for their first episode since January.  What have we been doing for work, dealing with the pandemic, and how have we been improving our craft?

    Let us know what you think.  What questions, challenges or success stories do you have regarding estimation?  What other process improvement or regulatory topics you'd like to have covered in future podcasts?  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com.  

    Becky Fitzgerald:  becky.fitzgerald@twohc.com
    Tom Klein tom.klein@twohc.com
    George Zack george.zack@twohc.com

    • 33 min
    2HC ep 14: revisiting size and estimation

    2HC ep 14: revisiting size and estimation

    Becky, Tom and George get together to revisit the concept of size in estimation of work and some ideas on how to approach it as an opportunity to improve.  2HC episode 2 (where we originally discussed estimation and size): ...

    • 47 min
    2HC ep 13: A Conversation with Jon Speer from Greenlight Guru

    2HC ep 13: A Conversation with Jon Speer from Greenlight Guru

    George is joined by the president of regulatory and quality at Greenlight Guru and the host of the Global Medical Device podcast Jon Speer.  Jon gives some of his insights as to what will be hot topics in the quality/regulatory world in 2021.

    Some reference links:
    The latest on the QSR migration to 13485 
    https://medtech.pharmaintelligence.informa.com/MT143243/FDA-Picks-New-Target-Date-For-Releasing-Its-Draft-Harmonized-Quality-System-Regulation
    The Payor pilot:
    https://www.fda.gov/about-fda/cdrh-innovation/payor-communication-task-force
    Greenlight Guru:
    https://www.greenlight.guru/
    The Global Medical Device Podcast:
    https://www.greenlight.guru/podcasts

    Are you enjoying this podcast?  If so, please share it with a colleague!  We'd love to have more people engage with us in these conversations.  And we always want your feedback about any element of podcast.  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com or George Zack at george.zack@twohc.com

    • 41 min
    2HC ep 12: You had an an appraisal, now what?

    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...

    • 23 min
    2HC ep 11: Ask An Appraiser Anything October 2020 Webinar

    2HC ep 11: Ask An Appraiser Anything October 2020 Webinar

    In this episode, we share a recording of the October 2020 Two Harbors Consulting "Ask An Appraiser Anything" webinar.  Lead Appraiser Tom Klein and George Zack of 2HC took questions on process improvement, the CMMI model, medical device regulation and approaches to appraisals.  This was the first webinar that 2HC held like this - and we think it went well enough that we will look to do more in the future.  Let us know what topics you'd like to see us address. 

    Are you enjoying this podcast?  If so, please share it with a colleague!  We'd love to have more people engage with us in these conversations.  And we always want your feedback about any element of podcast.  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com or George Zack at george.zack@twohc.com

    • 1 hr 3 min

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