Regulatory Open Forum

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  • 1.  Templates for Standard Operating Procedures

    Posted 22-Aug-2013 14:43
    I am interested in purchasing a set of templates for SOPs pertaining to GCP and GMP functions. I have located several on-line; however, wondered if anyone had experience with those templates available for purchase and what they would recommend.

    Thank you.


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    Suenell Broyer RAC
    Sr. Director Regulatory and Clinical Affairs
    Bigfork MT
    United States
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  • 2.  RE:Templates for Standard Operating Procedures

    Posted 22-Aug-2013 15:18
    ACRP has a free "starter set" for a site in their online library. It does not cover GCP for sponsors or GMP though  If you are not a member of ACRP, its probably cheaper for you to join ACRP than to buy an equivilent set.

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    David Vulcano RAC
    Assistant Vice President, Clinical Research
    Hospital Corporation of America (HCA)
    Nashville TN
    United States
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    Original Message


  • 3.  RE:Templates for Standard Operating Procedures

    Posted 22-Aug-2013 16:00
    Suenell:

    FDAnews has a set of GCP templates that you should consider. Here's a link to more info on that set:

    http://www.fdanews.com/store/product/detail?productId=42334


    Best,
    Michael


    ______________________________________________
    Michael A. Swit, Esq.
    Special Counsel, FDA Law Practice
    Duane Morris LLP
    750 B Street, Suite 2900
    San Diego, CA 92101-4681
    P: +1 619 744 2215
    F: +1 619 923 2648
    C +1 760 815 4762
    maswit@duanemorris.com

    Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

    Please follow me on LinkedIN and Twitter:
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    Original Message


  • 4.  RE:Templates for Standard Operating Procedures

    Posted 22-Aug-2013 16:17
    For your consideration, we, Regulatory Doctor, provide customized sets of SOPs for GLPs, GCPs, and GMPs for your business and product types.  

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    President and Principal
    http://www.regulatorydoctor.com
    Riner VA
    United States
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    Original Message