Regulatory Open Forum

 View Only

  • 1.  RAC Exam Prep

    This message was posted by a user wishing to remain anonymous
    Posted 29-Mar-2019 10:33
    This message was posted by a user wishing to remain anonymous

    Good  morning RAC Family,

    I am planning to write the RAC Exam. Does anyone know if getting the global certification offers any more benefit even her in the US? Also, I just got the 'Fundamentals of US Reguatory Affairs' textbook to start studying and would like to know if this is a good way to start. Lastly, what is your opinion on self-studying as an alternative to registering for prep classes to pass the RAC Exam?

    I look forward to kind responses on these, please.

    Thanks a lot.


  • 2.  RE: RAC Exam Prep

    Posted 29-Mar-2019 10:54
    I have self-studied and passed.  The questions are mostly application-based so there is actually very little rote memorization.  On-the-job experience is very valuable. The book can be helpful for the areas you have no direct experience in. If you are in devices, the book can be a good starting point for learning about drugs. And vice versa.

    ------------------------------
    Karen Zhou
    ------------------------------

    Original Message


  • 3.  RE: RAC Exam Prep

    Posted 29-Mar-2019 11:46
    I agree with Karen.

    The educational background in RA and on hand experience in RA will make large difference. Thats why RAPS made an eligibility criteria for the exam, that people can take RAC exam who has more than 3 years of industrial experience.

    Besides book you should read guidances published by FDA for the industries, that will be a really helpful.

    ------------------------------
    Gaurang Bhavsar, MS, RAC
    Manager, R&D and RA
    Sunrise Pharmaceutical, Inc.
    Rahway, NJ 07065
    USA
    ------------------------------

    Original Message


  • 4.  RE: RAC Exam Prep

    Posted 29-Mar-2019 12:11
    I would recommend to join some groups where they read on chapters and discuss the open item. Not everyone is master of Drug, Biologics and Devices while we specialize on one field and get a good understanding on other areas. Such group discussions really helps to score better as we get to hear the practical experiment and knowledge of various folks.

    ------------------------------
    Loganathan Kumarasamy
    Senior Consultant
    Waukegan IL
    United States
    ------------------------------

    Original Message


  • 5.  RE: RAC Exam Prep

    Posted 30-Mar-2019 12:39
    Hi!  I made flashcards out each chapter of the Fundamentals book and essentially memorized the Matrix of Regulations Across Product Lines in the back of the book. ​This was very helpful to strengthen my knowledge of regulation numbers, legislative and regulatory history, etc. even in areas where I didn't regularly work. This won't help you with application or process questions, though. As others have mentioned, your work experience and knowledge of guidance documents are your best assets for that. Understanding the test is critical for all standardized tests. RAPS provides exam outlines and checklists (check out your test on https://www.raps.org/rac-credential/prepare-for-the-exam) that break down the different content areas. That is what I used to prepare a study plan for myself. I also recommend paying to take a practice exam so that you get a feel for how the questions are structured, what the pace is like, and where your areas of weakness are.

    ------------------------------
    Jennifer Stohlmann RAC
    Regulatory Specialist
    New York NY
    United States
    ------------------------------

    Original Message


  • 6.  RE: RAC Exam Prep

    Posted 01-Apr-2019 08:09
    Hello,

    I took a very similar approach to Jennifer and passed. It's important to keep in mind your own learning/studying style - not everyone derives the same benefits from group studying vs individual studying vs prep classes. The best recipe for me was individual studying by making flashcards based on the Fundamentals book, reviewing guidances, taking the practice exam (you can take it multiple times with some variations in the questions), and supplementing this with ad hoc discussions with others about concepts I  was still struggling to fully understand.

    So, I would examine your own personal studying/learning preference, your work experience, your schedule and timeline, and your budget to determine how best to proceed. 

    Good luck!


    ------------------------------
    Courtney Portik
    Atlanta GA
    United States
    ------------------------------

    Original Message


Related Content