Regulatory Open Forum

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  • 1.  Hello, I'm a new member!

    Posted 24-Jan-2024 02:52

    Hello, my name is Angelina. I am fairly new to the field, and gained an interest in regulatory affairs through my experience in peptide manufacturing. I am currently studying for the RAC exam.

    What other training and certifications do you recommend to become an auditor in medical devices, cosmetics, biopharmaceuticals? Thank you!

    I would be happy to connect on LinkedIn!

    http://linkedin.com/in/angelina-huynh



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    Angelina Huynh
    Menlo Park CA
    United States
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  • 2.  RE: Hello, I'm a new member!

    Posted 24-Jan-2024 09:08

    Hello Angelina

    Welcome! First, best wishes as you prepare for the RAC exam. I do not have this certification, but I have worked with many others who have greatly benefitted from this credential in their careers.

    You ask about certifications for auditing. I would like to suggest that you first consider narrowing your focus - the three areas you have mentioned, they all require a lot of specialized training and experience.

    Best regards



    ------------------------------
    Naveen Agarwal, Ph.D.
    Problem Solver | Knowledge Sharer.
    Let's Talk Risk!
    @https://naveenagarwalphd.substack.com/
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    Original Message


  • 3.  RE: Hello, I'm a new member!

    This message was posted by a user wishing to remain anonymous
    Posted 25-Jan-2024 09:23
    This message was posted by a user wishing to remain anonymous

    ISO 13485 Lead Auditor Training might be interesting... lots of courses available


    Original Message


  • 4.  RE: Hello, I'm a new member!

    Posted 25-Jan-2024 10:40
    Edited by Elizabeth Bereza 25-Jan-2024 10:41

    Welcome!

    I agree with Naveen, that is a lot of areas to cover.  I don't know much about the other areas but I can provide a couple of suggestions for medical devices.

    First, ISO 13485 auditor training is always beneficial.  Many different organizations offer auditor and lead auditor training for this.  I did my ISO 13485 lead auditor training through Oriel Stat A Matrix.

    Secondly, I would suggest checking out ASQ.  I am a Certified Medical Device Auditor (CMDA) through ASQ.  They have resources as well as a certification exam.

    Hope this helps a little.  Let me know if you have questions!



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    Elizabeth Bereza RAC, MSRA, CMDA
    Senior Regulatory Affairs Specialist
    Indeio LLC
    Raleigh NC
    United States
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    Original Message


  • 5.  RE: Hello, I'm a new member!

    Posted 25-Jan-2024 12:39

    Hi,

    I hold US-RAC which I obtained while working as a Medical Device auditor. There are multiple types of auditor certificates. For example American Society for Quality offers CQA which is not industry specific but covers auditing practices. There are many organizations that offer lead auditor training with some specific to ISO13485 for medical devices.  After that course you are eligible to pursue Lead Auditor certification through Exemplar Global or IRCA. That would be intended for someone that is a full-time auditor.

    I would recommend working in as many areas of manufacturing, testing, R&D, complaint process etc. before becoming a full-time auditor.

    Good luck,



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    Elizabeth Nichols RAC
    Sr. Compliance Specialist/Int Auditor
    Port Washington WI
    United States
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    Original Message


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