Regulatory Open Forum

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  • 1.  Courses to choose for Regulatory career advancement

    Posted 27-Jun-2018 19:35
    Hello, 
    I have been thinking about taking courses/seminar's that would help me accelerate my regulatory career and might be useful to include them into my regulatory work. I am debating between this two areas since I work in Med device company as RA Specialist.
     1. Verification and Validation
    Course work: https://www.ucsc-extension.edu/certificate-program/offering/medical-device-verification-and-validation
    2. Risk Analysis/Risk Management ISO 14791
    Course Work: Risk Management for Medical Device | ASQ

    Any other coursework suggestions are welcome. Thanks

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    Jinali Bhavsar RAC
    Regulatory Affairs Specialist
    San Jose CA
    United States
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  • 2.  RE: Courses to choose for Regulatory career advancement

    Posted 28-Jun-2018 11:28
    Eventually I'd do both. However, I'd do the risk management one first, because it applies at all parts of the product life cycle and crosses more cross functional areas than V&V. Thus, it is an area where you can help RA add great value faster, as well as giving you skills in an area more and more regulators look to understand.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 3.  RE: Courses to choose for Regulatory career advancement

    Posted 28-Jun-2018 11:35
    ​I took the ASQ risk management course. It is helpful if you are new to risk management and are trying to get an understanding of all the aspects of it. However, if you have experience with risk management, then I would look to find a more advanced class.

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    Mica Elizalde
    Project Manager II
    Salt Lake City UT
    United States
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    Original Message


  • 4.  RE: Courses to choose for Regulatory career advancement

    Posted 29-Jun-2018 08:57
    You might also consider other more extensive coursework - I am most familiar with Seton Hall Law program for certificates related to pharmaceutical law and regulations as well as their Masters degree program.  I know other schools offer similar programs.  They are not inexpensive.  I did their Masters program and there were quite a few fellow students from the quality side of the business in it.

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    Glen Park
    Jersey City NJ
    United States
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    Original Message


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