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What's the best piece of RAC exam study advice you have?

  • 1.  What's the best piece of RAC exam study advice you have?

    Posted 18-Oct-2021 12:41
    The Autumn RAC exam period is almost here, so I thought it could be useful to get a thread going on some study tips.

    -What did you find helpful while studying for the RAC?

    -What advice would you give to someone who is about to take the test?

    Looking forward to hearing what you have to say!

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    Ryan Connors
    Community Engagement Coordinator
    RAPS
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  • 2.  RE: What's the best piece of RAC exam study advice you have?

    Posted 19-Oct-2021 02:02
    Good day,

    I found the Fundamentals of Regulatory Affairs by RAPS most helpful to read through.  Then becoming familiar with all of the regulations or standards which are in the scope of exam, more importantly key concepts of the regulations or standards as there can be so many to remember.  It certainly helps to have experience in those applications, but like most exams during the actual test it was reasoning through which of the answers was the best answer.  Study groups help too if can get a group together to talk through example situations or maybe discuss areas where you are not more comfortable.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: What's the best piece of RAC exam study advice you have?

    Posted 19-Oct-2021 10:12
    Like Richard said, IMO also, the Fundamentals of Regulatory Affairs by RAPS is a must-have and study.

    Then, ALL the regs that are listed at the end of each chapter in the book.

    This is a marathon, not a sprint!

    The above worked for me, without any study group, but if you can put one together, by all means, do it.




    ------------------------------
    Sorin Alb RAC
    Project Manager, Regulatory Affairs
    Scarborough ON
    Canada
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    Original Message


  • 4.  RE: What's the best piece of RAC exam study advice you have?

    Posted 19-Oct-2021 18:14
    Helpful 
    1. Completing practice test questions
    2. Reading the Fundamentals book focusing on areas where I may not have experience.  

    Advice

    1. Study with a friend and test each other.  
    2. I highly recommend getting a copy of a practice exam and just re-take that exam a few times to see where you can improve on.  
    3. Take the exam only when you are ready.
    4. Don't beat yourself up. You are not supposed to be an expert in every jurisdiction, but during your studies, try to find common themes. For smaller jurisdictions, get a bird's eye view and don't get mired in details.


    A question for the community:  Is Canada no longer tested on the RAC Devices exam?

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    Karen Zhou
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    Original Message


  • 5.  RE: What's the best piece of RAC exam study advice you have?

    Posted 20-Oct-2021 14:20
    Hi Ryan,
    What helped me most was having a study group. Not so very much because of the discussions during our weekly meeting (though those where helpful, too), but because it forced me to work through the Fundamentals Chapters more thoroughly. Our study group split up the chapters and each of use had to present 2-5 chapters of each of the relevant Fundamentals books. Our presentations were in the form of Word files that we then shared with the group. While those chapters I worked through were the ones I ended up being most familiar with, I did use other group members' word file summaries during while studying. 
    The most important part of the study groups was keeping me on the ball and forcing me to not get behind. After about 3 months of study group I still had 1.5 months to work through others' chapters and more importantly, solidify my understanding of the contents be reading the underlying guidances and regulations. In many cases those were actually easier to understand that the sometimes way too condensed subheadings of the Fundamentals book chapters. And running through various practice exams with the study group was also helpful. But the actual RAC exam still surprised. Some of the questions make you want to answer "all of the above" or "it depends" but you had to make your best guess based on what you learned and the gut instinct from your actual regulatory experience.
    In the end I passed. It was the 1st time I sat for the exam, but the 2nd time I'd signed up to take it. The 1st time I didn't manage to get even close to keeping up with my study plan so I skipped the exam.
    In any case I wish you good luck!

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    Anna Sedello, PhD, RAC
    Director of Regulatory Affairs
    Palo Alto CA
    United States
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    Original Message


  • 6.  RE: What's the best piece of RAC exam study advice you have?

    Posted 20-Oct-2021 02:11
    Hi Ryan

    I found it very useful to have a study group - there are usually quite a few people posting on RegEx about upcoming ones. Then structuring the study group right helps too, eg everyone does a reading then prepares dummy questions. This allows you to build up a good question bank which I find is a very good way to prepare. 

    Best
    Hamish

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    Hamish King
    Hong Kong
    hamish.king@cisema.com
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    Original Message


  • 7.  RE: What's the best piece of RAC exam study advice you have?

    Posted 20-Oct-2021 08:44
    Take the practice exams, focus on your weaknesses, learn how the questions are asked, familiarize yourself with the applicable regulations and corresponding guidance for the exam you are taking. Retake the practice exam after you have studied. Modify your studies based on what you learn. Remember you don't need a 100% but you need to be sufficiently confident that you can answer similar questions. Fundamentals is a good start as well as study groups. But ultimately, only you can determine what you know or don't know and then remediate that knowledge. As others have said, it is a lifelong journey, every day you learn something new or relearn something you have forgotten.

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    David W. Husman, Ph.D., RAC
    Senior Consultant
    PAREXEL Consulting
    Greenville, SC
    USA
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    Original Message


  • 8.  RE: What's the best piece of RAC exam study advice you have?

    Posted 21-Oct-2021 09:50
    Thank you for such detailed responses, everyone!

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    Ryan Connors
    Community Engagement Coordinator
    RAPS
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    Original Message


  • 9.  RE: What's the best piece of RAC exam study advice you have?

    This message was posted by a user wishing to remain anonymous
    Posted 25-Oct-2021 11:12
    This message was posted by a user wishing to remain anonymous

    Thanks for posting this question.  I am sailing in the same boat and feels like trying to swim in the ocean of knowledge to cover.

    Following the post.

    Already have found many helpful suggestions and pointers. 

    Original Message


  • 10.  RE: What's the best piece of RAC exam study advice you have?

    Posted 26-Oct-2021 15:10
    I would echo advice on the Fundamentals book, study group and practice tests.  I would also add that reviewing some of the published guidance documents (FDA, MDCG, etc.) proved to be helpful for me.  One observation of our study group (all employed at the same company) was that we tended to answer the practice exam questions based on how we had been taught/trained on-the-job.  Once we took a conscious step back and looked at the question(s) more holistically, our practice scores improved.  I believe that I was able to apply that approach on test day.  Just don't rely on practice exam content to clue you in on the actual exam questions.

    On test day, relax and read each question and ALL of the answers before responding.  Then try to think in terms of what a mainstream RA Specialist should do in the stated situation vs. what you would likely do in your current situation.  Depending on your company's culture, they may (a) differ slightly or (b) be situations where you might handle a portion and someone else (manager, int'l counterpart) might handle another.  If I wasn't sure, I'd skip that question and go on to the next.  You can go back and revisit any skipped questions (assuming the format is the same and you have time remaining).

    Good luck to the Autumn RAC Exam takers!

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    Robin Haden RAC
    Sr. Regulatory Affairs Specialist
    New Hill NC
    United States
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    Original Message


  • 11.  RE: What's the best piece of RAC exam study advice you have?

    Posted 26-Oct-2021 16:49
    I would agree with Robin, read the questions completely and all answers. Stop and think, what are they really asking? Pay attention to all parts of the question. The practice exams are to teach you how to approach a question, not necessarily the specific question. Only one answer is completely correct, but several may be correct in part but not in the whole, so don't jump too quickly. I had a question 25 years ago related to a contamination and the question was phrased you receive a complaint from a pharmacist about a purple pill found in a previously unopened container, who do you notify first? You were supposed to pick up on this is a medical professional, not a consumer, it was unopened, not potential mix up at consumer end, treat it as real contamination/ mix up - recall is in play and potential counterfeiting too and act accordingly. If you jumped to quickly or skipped over the key points, you might treat it as only a simple product complaint and execute investigation normally, not expeditiously.

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    David W. Husman, Ph.D., ASQ CPGP, RAC
    President and Principal Consultant
    David Husman Consulting, LLC
    Greenville, SC
    USA
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    Original Message


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