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  • 1.  RAC US Exam

    Posted 18-May-2018 13:22
    Hello, I was participating in a local RAC US study group session last evening.  A question was asked whether the RAC US exam includes questions related to FDA guidance documents, specifically should one know the most recent guidance documents in order to choose the best answer for the analysis questions on the test?   Any advice would be appreciated.

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    Ronald Warren RAC
    San Diego CA
    United States
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  • 2.  RE: RAC US Exam

    Posted 18-May-2018 15:50
    US RAC exams have certain questions that are based on case studies and regulatory guidance's including knowledge of CFR (Code of Federal Regulations) and FDA guidance`s.

    FDA guidance`s updates routinely based on healthcare industries and patient requirements. They provide the guidance that how industries needs to conduct business in compliance to FDA expectations and statutory requirements set by FDA. 

    I passed the RAC US exam in June 2017 and I strongly recommend that whomever wish to appear in the examination, they have to read all the guidance's published by FDA.

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


  • 3.  RE: RAC US Exam

    Posted 16-Sep-2019 07:22
    As far as reading  guidance ​documents goes, I agree with Christine. I would suggest certain ones are more likely to be useful to the RAC than others, such as on topics that are highly likely to occur frequently in the course of a drug's life cycle or daily regulatory requirements. Examples of that would be the FDA/ ICH guidances on comparability protocols, risk assessment, QMS, GCPs, API GMPs, and Life Cycle Management.

    I hope this is helpful.

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    Arvilla Trag RAC
    Director
    BioProcess Technology Group
    BDO
    Boston MA
    USA
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    Original Message


  • 4.  RE: RAC US Exam

    Posted 19-May-2018 04:30
    Ron,

        I passed the RAC (US) exam in Dec 2017 and, while I think it is a good idea to review FDA guidance documents, the exam questions focused on settled areas and did not include questions about recent changes.   For example, neither the RAPS testing material I used nor the exam itself included significant content or questions regarding the 21st Century Cures Act.    I think you are better off making sure you have core materials under your belt rather than trying to know the absolute latest, since the exam doesn't seem to be updated that often.

    Roger

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    Roger Cepeda, JD, MBA, RAC
    MedTech Law LLC
    roger@medtech.law
    Mobile: 847-421-8361
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    Original Message


  • 5.  RE: RAC US Exam

    Posted 14-Sep-2019 16:15
    Thank You, Roger. This information is very helpful.

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    Srikanth Navuluri
    Regulatory Affairs Associate
    Gaithersburg MD
    United States
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    Original Message


  • 6.  RE: RAC US Exam

    Posted 19-May-2018 09:15
    ​Considering that there are currently FDA currently lists 4,219 guidances at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm, I don't think that it is realistic to read each one.  But it has been useful for me to go into specific guidances (such as those on post-market changes to drugs and devices) to get more detail about FDA expectations. Additionally, the instructions for the current exam specifies that it is testing on regulations through December 31, 2016 (https://www.raps.org/getattachment/RAC-Credential/Prepare-for-the-Exam/2018-RAC-Fact-Sheet.pdf.aspx ) .  So none of the recent changes from the 21st Century Cures Act will be incorporated into exam questions.

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    Christine Campbell
    Senior Scientist-Clinical Science Liaison
    Winston Salem NC
    United States
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    Original Message


  • 7.  RE: RAC US Exam

    Posted 22-Sep-2019 06:52
    I passed the US RAC exam in Spring 2019 and do not feel attempting to review all or even most of the FDA guidance documents would be a good use of your time. I would focus on the regulations and law; use guidance documents where clarity is needed to fully comprehend a subject area. I can't think of a single question that directly related to (only) a guidance document.

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    Alicia Staz
    Sr. Manager, Quality & Regulatory Affairs
    Plano TX
    United States
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    Original Message


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