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  • 1.  "Authoring Regulatory Documents"

    This message was posted by a user wishing to remain anonymous
    Posted 31-Oct-2022 09:31
    This message was posted by a user wishing to remain anonymous

    Hello All,
    Please provide guidance, suggestions, and information on any available course on 'Authoring regulatory documents.
    I want to enhance my writing skills.
    Recently my organization laid off me due to not being able to write effective regulatory documents.

    Thanks 




  • 2.  RE: "Authoring Regulatory Documents"

    Posted 31-Oct-2022 10:45
    Dear Anon, I am sorry to read that you got laid off. This is a very special interpretation of clause 6.2 b) Of ISO 13485: "provide training or take other action to achieve or maintain the necessary competence"......
    Nancy Singer is well known for, amongst others, her writing courses for regulatory persons. Several short courses are planned and can be found in the RAPS calendar Upcoming events. I am pretty sure that if you check her website other courses can be found.
    Success with your endeavor!

    ------------------------------
    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs | Head of Training
    Arnhem
    Netherlands
    ------------------------------

    Original Message


  • 3.  RE: "Authoring Regulatory Documents"

    Posted 01-Nov-2022 06:18
    In addition to Peter's excellent suggestion, many local community colleges offer technical writing courses that may be of benefit.

    Good luck!

    ------------------------------
    Mark De Rosch FRAPS
    Chief Operating Officer, Aura Biosciences
    Laconia NH
    United States
    ------------------------------

    Original Message


  • 4.  RE: "Authoring Regulatory Documents"

    Posted 01-Nov-2022 06:27
    Edited by Richard Vincins 01-Nov-2022 06:27
    Hello,

    Indeed sorry to hear about your circumstance.  As Peter mentioned there are a few specific writing course for regulatory/quality individuals which are offered independently and even some which are touched through RAPS offerings.  I wanted to comment another area you can look at is your local Community College or University.  I took a couple Technical Writing courses during my studies which helped me tremendously, not just writing regulatory documents, but writing, presenting, and formulating technical documents in general.  This helped me tremendously understanding grammar in technical papers, how to present information, and structuring more technical documents made for the audience.

    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 5.  RE: "Authoring Regulatory Documents"

    Posted 02-Nov-2022 11:45
    I am sorry to read that you have been let go.

    My first suggestion is an entry level course in journalism. It will provide great general writing help and also teach you to write strategically so that you know how to craft a document for your target audience. (In the interest of full disclosure, my first career was in journalism and that experience has been invaluable to me.) Suggestion two is to investigate the many courses for technical writing available on line.  I think UC Berkeley, - San Diego and - Irvine offer such classes.  Good luck.

    ------------------------------
    Stephanie Boyle Mays
    Senior Regulatory Affairs Specialist
    Redmond OR
    United States
    ------------------------------

    Original Message


  • 6.  RE: "Authoring Regulatory Documents"

    Posted 04-Nov-2022 14:37
      |   view attached
    Hi Anon, I'm sorry to hear about your situation. I have a few resources I can point you towards: 

    • General writing: I recommend buying the book "A Writer's Reference" by Diana Hacker (available on Amazon/eBay for as little as $4-5). You don't even need to buy the latest edition (not sure what edition they are up to now). I used the 6th edition in a college writing course and it's been invaluable to me. I keep my old copy in the office to share examples with my team (especially interns) from time to time. The fundamentals of good writing are the same across disciplines.
    • Technical writing: I'm attaching a presentation I found online on the sentence structure of technical writing. It's pretty helpful and has plenty of examples.
    • Regulatory writing: I recommend buying the RAPS book "Regulatory Writing, An Overview". It explains in detail how to write different types of regulatory documents. It was helpful to me earlier in my career and now I keep share it as a team resource. Once again, you do not need to get the latest edition.
    Good luck!

    ------------------------------
    Hiral Dutia
    Manager, Regulatory Affairs
    Third Pole Therapeutics
    Waltham, MA
    USA
    ------------------------------

    Attachment(s)

    pdf
    Sentence Structure of Technical Writing.pdf   281 KB 1 version
    Original Message


  • 7.  RE: "Authoring Regulatory Documents"

    Posted 23-Dec-2022 07:55
    In addition, I will also suggest a book Writing for the Biopharmaceutical Regulatory Writer by Gregory Cuppan and Stephen Bernhardt. There are other books in RAPS on regulatory writing.
    Best,
    Shivam

    ------------------------------
    Shivam Mishra
    Québec QC
    Canada
    ------------------------------

    Original Message


  • 8.  RE: "Authoring Regulatory Documents"

    Posted 24-Dec-2022 12:04
    Sorry to hear, Anon.

    Great posts earlier. To suggest few more, there are great courses on Udemy Top Technical Writing Courses Online - Updated [December 2022] | Udemy and also on Coursera Best Technical Writing Courses & Certifications [2023] | Coursera

    Personally I did this course Writing in the Sciences | Coursera and found it to be very useful.

    After you learn these skills, there are three important things you need to do ... practice, practice, and practice.  

    Best luck, Anon!

    ------------------------------
    Ajit Basrur
    Worcester MA
    United States
    ------------------------------

    Original Message


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