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  • 1.  QMSR Training by the FDA

    This message was posted by a user wishing to remain anonymous
    Posted 15 days ago
    This message was posted by a user wishing to remain anonymous

    Hello. Does anyone know of any training on QMSR done by the FDA?



  • 2.  RE: QMSR Training by the FDA

    Posted 14 days ago

    Anon,

    They will probably having something up in the CDRH Learn, but as this was recently published, might still be working on this aspect.  To be frank, if your organisation is already ISO 13485 compliant or certified, there is not that much difference with the Quality Management System Regulation.  I would even venture to say you could "self learn" the QMSR though usually auditors are looking for some evidence of training, which self-taught raises challenging questions.



    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
    ------------------------------

    Original Message


  • 3.  RE: QMSR Training by the FDA

    Posted 14 days ago

    FDA does not provide training to industry. Right now FDA is training their own employees on the new QMSR. 

    The FDA does provide employees to AAMI to assist in the AAMI training courses whenever possible. Now that the QMSR is final, AAMI is updating all their courses to the new regulation, but that will not be complete for some time.  There is a present course which covers the entire Quality System on both the current 21 CFR 820 (not the QMSR) and ISO 13485:2016. It does not yet cover the QMSR so you may want to wait until the updated course is available. But if you don't want to wait, the current course is very close and instructors can address specific questions as the present 820 and ISO 13485 are 95% the same according to analysis done by FDA and AAMI. 

    I will be teaching the AAMI Risk Management course (3days) next month. I suspect we will get lots of questions on the QMSR and I will be prepared to answer them as best as possible when we still do not have the updated FDA inspection manual. FDA has indicated that risk management will be a major focus of the new QMSR. The AAMI Risk course will be updated to the new QMSR but a lot of the present course already covers what is in QMSR. 



    ------------------------------
    Edwin Bills
    Edwin Bills Consultant
    ASQ Fellow CQE, CQA, CQM/OE, RAPS RAC, Member ISO TC 210 JWG1
    elb@edwinbillsconsultant.com
    ------------------------------

    Original Message


  • 4.  RE: QMSR Training by the FDA

    Posted 14 days ago

    I do need to add a correction especially in Richard's reminder. FDA does not directly do in person training, which is what I was originally considering. 

    However, thru DICE and CDRH Learn they do provide some excellent video courses. The same instructors there often appear in the AAMI Public training courses and respond directly to attendees questions. 



    ------------------------------
    Edwin Bills
    Edwin Bills Consultant
    ASQ Fellow CQE, CQA, CQM/OE, RAPS RAC
    elb@edwinbillsconsultant.com
    ------------------------------

    Original Message


  • 5.  RE: QMSR Training by the FDA

    Posted 13 days ago

    Besides what has already been mentioned by Richard and Edwin, there is a yearly Regulatory Education for Industry (REdI) Annual Conference which I assume will this year make a deep-dive into the developments around the QMSR. Though, the agenda has not been published yet. It is for free and you can register here: https://www.fda.gov/drugs/news-events-human-drugs/regulatory-education-industry-redi-annual-conference-2024-innovation-medical-product-development



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    Roger Christinger
    Lead RA/QM Consultant, RAC-Devices
    Zühlke Group, Switzerland

    https://www.zuehlke.com/en/industries/medical-device-healthcare
    ------------------------------

    Original Message


  • 6.  RE: QMSR Training by the FDA

    Posted 13 days ago

    Thanks for bringing that up Roger - the REdI annual conference is really nice, can attend online, and it is free !  Indeed, I am sure that will be a topic on the agenda this year.



    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
    ------------------------------

    Original Message


  • 7.  RE: QMSR Training by the FDA

    Posted 13 days ago

    The Agenda has just been released: https://sbiaevents.com/files2024/REdI-2024-Agenda.pdf



    ------------------------------
    Roger Christinger
    Lead RA/QM Consultant, RAC-Devices
    Zühlke Group, Switzerland

    https://www.zuehlke.com/en/industries/medical-device-healthcare
    ------------------------------

    Original Message


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