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  • 1.  Is anyone reading this??

    Posted 05-Aug-2016 09:06

    Good morning and happy Friday, Twin Cities!!

    First off, we are the QUIETEST bunch of networking RA people ever! Is anyone reading the posts on this platform? Just like this message below to let me know! :)

    Second, I am delinquent on a couple of items for the chapter (blame it on the UDI compliance deadline...)

    The follow-up survey for the July event should be in your inbox next week - watch for it. 

    • An informal Chapter Planning meeting will be held on Thursday 11 Aug at 5:00pm at Caribou Coffee (11210 Wayzata Blvd, Minnetonka). This is in the shopping area where Trader Joe's, Dick's and Bed, Bath & Beyond are located. We will be talking about a post-Convergence meeting and our Nov event. Meeting shouldn't last more than an hour and anyone is welcome to attend. (I will have a RAPS sign on the table and will even buy coffee for the first 5 people to show up!!!)

    Lastly, are you going to RAPS Convergence in Sept?? Please respond below as I would like to personally meet and say hi all MN attendees.

    OK. That's all I've got for you at the moment. But since it's a beautiful morning, I hope you don't blame me.

    Cheers!

    Lena

    ------------------------------
    Lena Cordie
    Qualitas Professional Services, LLC
    Watertown MN
    United States
    ------------------------------


  • 2.  RE: Is anyone reading this??

    Posted 08-Aug-2016 09:44

    There is no "like" button, but I did "recommend" this post ;-)

    I will be at the RAPS convergence, looking forward to a great meeting!

    ------------------------------
    Nancy Cameron RAC
    Sr. Pr. Regulatory Affairs Specialist
    United States

    Original Message


  • 3.  RE: Is anyone reading this??

    Posted 09-Aug-2016 09:28

    Hi, Lena,

     

    I will be attending the RAPS Convergence – look forward to seeing you there!  J

     

    Sue

     

    Sue Weinacht
    Specialist II, Regulatory Affairs
    Regulatory Operations


    St. Jude Medical
    One St. Jude Medical Drive
    St. Paul, MN 55117
    Tel +16517563154
    Fax +17633832771
    sweinacht@sjm.com
    sjm.com

     


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    Original Message


  • 4.  RE: Is anyone reading this??

    Posted 09-Aug-2016 09:33

    'Recommend' is even better! I will look for you at Convergence.

    ------------------------------
    Lena Cordie
    Qualitas Professional Services, LLC
    Watertown MN
    United States

    Original Message


  • 5.  RE: Is anyone reading this??

    Posted 08-Aug-2016 10:02

    Hi Lena!

    I'm going to be at Convergence in September! I'm new to Regulatory so it should be a fun way to digest a lot of information in a short time. Do you have any recommendations for things I should read or do prior to convergence to make the most of it? 

    Thanks,

    ------------------------------
    Maddi Myers
    Regulatory Affairs Specialist
    Lutonix, A subsidiary of C. R. Bard
    New Hope MN
    United States

    Original Message


  • 6.  RE: Is anyone reading this??

    Posted 09-Aug-2016 07:57

    Hi everyone! I did reply but don't see it here. I am not going to the Convergence this year but am part of Medical Alley's Regulatory Affairs Advisory Board.   Our Regulatory 101 seminar will be on September 15..more.information at www.medicalalley.org look under the events calendar.

    This is a great overview for Regulatory, Quality and your technical teams on basic US regulatory paths and requirements for both drugs and devices.

    Best regards,
    Ginger Cantor, RAC, MBA
    Centaur Consulting LLC centaurconsultingllc@gmail.com
    715-307-1850




    Original Message


  • 7.  RE: Is anyone reading this??

    Posted 09-Aug-2016 09:57

    Maddi,

    Welcome to Regulatory - we are a crazy bunch of people! I've been to so many RAPS Convergences, I barely remember my first one. Here are some pointers you might find helpful:

    • Before attending, review the session schedule and plan out what you want to attend. I like to identify mine as "must see" and "would like to see" so I always have a back-up to go to if needed.
    • Update your profile on Regulatory Exchange. It's a great way to get your name out there and your face so your connections can recognize you! 
    • Pack plenty of business cards!
    • Don't be afraid to ask questions. Believe it or not, I was (ok, still kind of am) shy and nervous when asking questions, but don't be! The crowd doesn't bite and I guarantee there is someone out there with the same question.
    • Attend the Exhibitor's Hall. The more of these you attend, the more companies you will recognize. And that's a major part of networking.
    • Get out and enjoy the beautiful city of San Jose. The organizing committee puts a lot of work into selecting the host city so attendees have an opportunity to relax and think non-regulatory thoughts for a bit.

    Finally, HAVE FUN!

    See you there!

    Lena

    ------------------------------
    Lena Cordie
    Qualitas Professional Services, LLC
    Watertown MN
    United States

    Original Message


  • 8.  RE: Is anyone reading this??

    Posted 09-Aug-2016 10:44

    Hi Lena,

     

    I will be attending RAPS Convergence in September. I hope to see you at Caribou on Thursday, too. I'm going to the Twins game, weather permitting, but should be free by 5:00.

     

    Cheers,

    Rachel

     

    Rachel Kennedy

    Senior Principal Advisor

     

    image001.jpg@01CDF7E2.A079AA50

     

    RCRI®, Regulatory & Clinical Research Institute, Inc.

    5353 Wayzata Blvd. Suite 505

    Minneapolis, MN 55416

    Direct: 952-224-2250   Office: 952-746-8080   Fax: 952-884-6518

    rkennedy@rcri-inc.com      www.rcri-inc.com

     

    RCRI is ISO 9001:2008 certified

     

    This e-mail is intended only for the person(s) named and is considered confidential and proprietary.  Any other use, duplication, or disclosure by anyone other than the intended recipient is strictly prohibited.  If you have received this e-mail in error, please notify the sender immediately.

     

     




    Original Message


  • 9.  RE: Is anyone reading this??

    Posted 09-Aug-2016 06:51

    I am reading this.  I cannot attend Converge, but I review this site daily.  I work in tissues - not medical devices, so my regulatory experience and interest is limited, but RAPS is very important to me for keeping up on industry news-

    ------------------------------
    Lori Hanley RAC
    Regulatory Compliance Associate
    National Marrow Donor Program
    Saint Paul MN
    United States

    Original Message


  • 10.  RE: Is anyone reading this??

    Posted 09-Aug-2016 12:58

    I read all the posts. That said, typically my paradigm is to reply to things, not to start new threads. I can't make Convergence this year - the schedule is too tight with my vacation and with the annual AdvaMed meeting a couple of weeks later. If anyone else will be attending AdvaMed, ping me and perhaps we can connect.

    G-

    ------------------------------
    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Monteris Medical
    United States

    Original Message