Regulatory Open Forum

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  • 1.  MDSAP Forum

    Posted 06-Sep-2017 15:49
    I am interested in getting feedback on the need/desire for an ongoing mechanism for any organization or person focusing on how MDSAP is being implemented to have a central point of connection with others having similar longer-term interest, especially accessing and involving key regulators.  I would expect larger companies (multi-site/multi-country), regulators, consultants trying to assist those wanting certification, AO's, standards organizations and would-be AO's to be interested, among others.  The opportunity is that since MDSAP is still a generally unknown, and potentially evolving process, having a forum (in addition to RAPS, which is so broad) to support those entities and provide feedback to regulators might be useful.  I'm also seeking thoughts on where and how that group might meet, through RAPS, an on-line mechanism like LinkedIn and/or routine meetings.

    I plan on attending the IMDRF Stakeholders Day in Ottawa on September 20th, hoping that this might also be a venue for this discussion as well as updates on MDSAP implementation.  I will also be at a networking event held on Tuesday, September 19th at the Lieutenant's Pump, 361 Elgin Street from 5:00 to 7:00 p.m. (a short 10 minute walk south on Elgin Street from the Lord Elgin Hotel) for anyone wishing to chat about this in person -- see the 8/30 RAPS Regulatory Open Forum Digest (sent 8/31) posting #3 to connect with Dinar Suleman about an RSVP.  Otherwise, your thoughts about this would be appreciated here.



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    Rem Siekmann, ASQ CBA
    Principal Engineer
    Mentor OH
    United States
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  • 2.  RE: MDSAP Forum

    Posted 07-Sep-2017 06:41
    I would agree that a MDSAP specific forum would be great, especially if RAPS could host it in addition to the Open Forum.  I believe that the topic has sufficient ongoing interest, and a specific forum would keep comments topic specific.







  • 3.  RE: MDSAP Forum

    Posted 07-Sep-2017 08:18
    I feel this would be quite useful to many and very interested in getting involved early on.

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    [Whitney] [Davis]
    [Global Regulatory Affairs Specialist]
    [Laboratory Products Division]
    [Thermofisher Scientific]
    [Marietta] [OH]
    [USA]
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  • 4.  RE: MDSAP Forum

    Posted 07-Sep-2017 11:34
    Some observations about RAPS forums...

    Anyone can set up a subforum on RegEx at any time, on their own, in a matter of minutes, without involving RAPS.  There are some 50 subforums available, most of which were set up by RAPS, sometimes of its own initiative, and sometimes upon request, very few as an individual initiative. 

    The value of involving RAPS is that, if you have a defined membership, such as all member residing in Florida, for a Florida chapter subforum, RAPS can create the subforum with all of these RAPS members as members of the subforum, without them having to take the initiative to join.  There is no pre-defined group of RAPS members who have an interest in MDSAP, so members would have to take the initiative to join the subforum.

    The subforums get very little use.  I think the main reason is that they have little visibility.  Even if someone is interested in posting on a subject (eg, starting a RAC US study group) for which there is a dedicated subforum (eg, the RAC US Exam subforum), they will post it in the Open Forum instead of the dedicated subforum, because the Open Forum is what they see when they come here.

    The subforums that have a pre-determined membership seem mostly to serve the purpose of being able to send a message to that membership, rather than as an actual forum for discussion.

    RAPS subforums are accessible only to RAPS members.  If you are looking to set up a forum that is open to any MDSAP user, then a RAPS subforum would not serve that objective.  If you are looking to serve RAPS members only, a RegEx subforum would be just the place to do it.

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
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  • 5.  RE: MDSAP Forum

    Posted 08-Sep-2017 10:00
    Thanks for bringing up such a great idea and important topic. We are currently working on some ideas and a strategy that will make the most sense for RAPS members to be able to participate and converse on this topic.

    Stay tuned!

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    Heather Arkwright
    Community Manager
    RAPS
    regex@raps.org
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