23 episodes

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

Two Harbors Consulting Podcast Two Harbors Consulting LLC

    • Business
    • 5.0 • 1 Rating

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

    2HC ep 23: A conversation with Naveen Agarwal

    2HC ep 23: A conversation with Naveen Agarwal

    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!) 

    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 Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family.

    You can find him and information about his work, especially regarding risk management for medical devices here:   

    https://www.achievexl.com/
    https://www.linkedin.com/in/naveenagarwal/

    You can also watch this episode here:  https://www.youtube.com/watch?v=DERVviyppL0 

    • 1 hr 3 min
    2HC ep. 22 - How about a season 2?

    2HC ep. 22 - How about a season 2?

    Becky, Tom and George reconvene on this podcast after a year long break from it.   They discuss what topics they see coming up in future episodes in this "season 2."  What performance improvement topics do you want to see discussed?   

    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

    • 37 min
    2HC ep 21: MDDAP interviews

    2HC ep 21: MDDAP interviews

    George is joined again by Lynn Penn (https://www.linkedin.com/in/mlpenn/) from Performance and Methods Consulting.  They dive back into the CMMI appraisal interviews - specifically those for MDDAP appraisals:  what makes for a good interview, what are some challenges, and how to be ready to manage the room.  

    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

    • 52 min
    2HC ep 20: Where do medical device regulations and the CMMI intersect? A conversation with Beth Layman.

    2HC ep 20: Where do medical device regulations and the CMMI intersect? A conversation with Beth Layman.

    George has a conversation with CMMI Lead Appraiser Beth Layman of Layman and Layman Consulting about the intersection of the CMMI Model with the US medical device quality system regulation (the QSR).  

    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:  http://www.twoharborsconsulting.com or at George Zack george.zack@twohc.com
    Beth's contact information:  beth.layman@laymanandlayman.com or http://www.laymanandlayman.com/

    • 48 min
    2HC ep 19: Paul Kimmerly and the lead appraiser observation process

    2HC ep 19: Paul Kimmerly and the lead appraiser observation process

    Becky and George have a conversation with Paul Kimmerly about the observation process of CMMI lead appraisers.  George just went through the observation process and Paul was his observer.  The team discusses why these are done,  common improvement opportunities for new appraisers, what is good about them and what could be improved.  

    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:  http://www.twoharborsconsulting.com or at

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

    Paul's contact information:  paul.kimmerly@doubleplayconsulting.com

    • 51 min
    2HC ep 18: The Interview

    2HC ep 18: The Interview

    Appraisal activities include "the interview."  What is it for?  Why do it?  How is it done in CMMI appraisals?  How should I prepare for an appraisal interview if I am an interviewee?

    Tom and George discuss all of these and more as they unpack this aspect of appraisals.  

    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.  

    Tom Klein tom.klein@twohc.com
    George Zack george.zack@twohc.com

    • 23 min

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