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Regulatory guidances

  • 1.  Regulatory guidances

    Posted 11 days ago

    Hi ,

    What is right way to read the regulatory guidance (since they are long documents) , note the information?  to be able to retain the information and so that it can be used appropriately to develop stratetagy

    Thank you

    Priya



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    Priya Bhatia
    Sunstar Americas Inc
    Schaumburg IL
    United States
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  • 2.  RE: Regulatory guidances

    Posted 11 days ago

    Hi Priya

    I like that question!

    One of the things that helps is practice. The first time I tried to read one, it was hard work. Now that I'm familiar with the style, I find them much easier to read.

    Another thing that works for me is putting them in context. For example, if I'm reading a guidance about recalls, I think of a product I know well and imagine that I need to recall it according to the guidance, working through all the steps to understand how it would work.

    Gap assessments can also be useful. For example, take a new recall guidance and drop it into a spreadsheet. Then for each paragraph in the first column, fill in the second column with the section number of the SOP that covers that step. If there's anything you can't find in your QMS, it may be a new requirement you'll need to add.

    Besides the main content of the document, get in the habit of reading the forewords, preambles, and informative annexes. For FDA documents, get the Federal Register notices, too. They'll give you useful context to help understand the reasons for the document and how it fits with other documents.

    Webinars, blog posts, and forum discussions may help to give you an overview of what's in a document, before you dig into the details, so you'll know what to expect and recognize it when you see it.

    You can be curious and hop from section to section to see what's in a document. You can be diligent and read it from cover to cover. Better yet, do both.



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    Anne LeBlanc
    United States
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  • 3.  RE: Regulatory guidances

    Posted 11 days ago

    Schedule a meeting with colleagues, to explain it to them. Figuring out how to tell the story (and being prepared to answer questions) may help you understand it more deeply 



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    Anne LeBlanc
    United States
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  • 4.  RE: Regulatory guidances

    Posted 10 days ago

    Thank you Anne for your input. Appreciate that.



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    Priya Bhatia
    Sunstar Americas Inc
    Schaumburg IL
    United States
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  • 5.  RE: Regulatory guidances

    Posted 10 days ago

    These are very good points. Finally, I would add a quick reference guide that should be created with a link to the guidance because as humans we tend to forget and if you are asked in future, a quick reference will help in getting the document.



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    Winston Costa Pereira
    Regulatory Submissions Specialists
    York ON
    Canada
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  • 6.  RE: Regulatory guidances

    Posted 5 days ago

    Well said @Anne LeBlanc, well said! Thank you for your perspective and suggestions! 



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    Beth Lentz
    RIMSYS
    Pittsburgh PA
    United States
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  • 7.  RE: Regulatory guidances

    Posted 11 days ago

    Hi Priya,

    There is no one size fits all approach. Something that I do is to google about the guidance document before I read it page by page. There will be many articles which capture the highlights from the guidance document and then read the actual document. Some of them are very dense in nature and could take multiple reads. I usually dont try to retain everything that is in the guidance document. I merely try to remember the existence of guidance document on a particular topic and if I am in a situation where I need to use it, I go back and read it again.

    Hope it helps! 



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    SamhithaMohan
    Sr. Staff Regulatory Affairs Specialist
    United States
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  • 8.  RE: Regulatory guidances

    Posted 10 days ago

    Anne's Excel suggestion is excellent in order to really assess the impact on a your company's processes. What I have found helpful is to summarize the guidance in a ppt slide deck, including both a summary and an impact assessment for my company. That helps really digest the content and remember it in the future! Good luck.



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    Anna Sedello, PhD, RAC-Drugs
    Executive Director of Regulatory Affairs
    Alpine Immune Sciences
    Redwood City CA
    United States
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  • 9.  RE: Regulatory guidances

    Posted 10 days ago

    Thank you Anna



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    Priya Bhatia
    Sunstar Americas Inc
    Schaumburg IL
    United States
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  • 10.  RE: Regulatory guidances

    Posted 10 days ago

    Thank you Samhitha for sharing your way. Appreciate that.



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    Priya Bhatia
    Sunstar Americas Inc
    Schaumburg IL
    United States
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  • 11.  RE: Regulatory guidances

    Posted 10 days ago

    Hi Priya,

    I like to highlight the impactful content using the PDF highlight tool.  Also, as you review a guidance, draft a corresponding procedure and form revision to incorporate the content.  I often create forms that include important guidance content verbatim (to be deleted when the form is completed or used to create a record).



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    Tim White
    RA Manager
    Frisco TX
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  • 12.  RE: Regulatory guidances

    Posted 10 days ago

    Hi Tim, 

    Thank you for your feed back.  Do you mean for example FDA meetings guidance , do you create SOP and form associate with it? 



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    Priya Bhatia
    Sunstar Americas Inc
    Schaumburg IL
    United States
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  • 13.  RE: Regulatory guidances

    Posted 9 days ago

    Hello,

    for major guidances we perform a full documented gap analysis with scoring on every requirement (2 = compliant, 0 = not compliant, 1 = compliant, but improvements possible). In the gap analysis, we also document where the requirement is embedded in our QMS ...

    The creation of those gap analysis is a quite big investment (initially) but afterwards it is even a cost (and time) saver



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    Franky Dubois
    QA/RA Manager
    FEops
    Gent
    Belgium
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