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Compliance and Regulatory

Latest Compliance and Regulatory Resources

The FDA Called…Are You Prepared?

Learn best practices for preparing for FDA audits at your research site, including the use of a clinical trial management system (CTMS) for documentation.

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How Paper and Electronic Source Data Meet ALCOA Elements

According to the FDA, data should meet certain fundamental elements of quality (ALCOA), whether they’re recorded on paper or electronically.

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FDA Guidelines for Drug and Device Determinations Q&A – Part 2

Dr. Molly Klote of the US Army Medical Corps answers questions surrounding FDA guidelines for drug and device determinations. Part 2 of 2.

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FDA Guidelines for Drug and Device Determinations Q&A – Part 1

Dr. Molly Klote of the US Army Medical Corps answers questions surrounding FDA guidelines for drug and device determinations. Part 1 of 2.

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FDA Regulations for Drugs and Devices Made Simple

Dr. Molly Klote, from the US Army Medical Corps, shares how she uncomplicated a complex topic like FDA regulations for IDEs and INDs.

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Examining 21 CFR Part 11 and the Role of Technology – Q&A (Part II)

Tom Beatty of QPharma, Inc. continues to answer questions posed during his recent webinar on 21 CFR Part 11 and the role of technology.

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Examining 21 CFR Part 11 and the Role of Technology – Q&A (Part I)

As a follow up to his recent webinar, Tom Beatty of QPharma, Inc., answers questions surrounding 21 CFR Part 11 compliance.

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Aiding Clinical Research Compliance with SOPs – Part II

In response to her recent webinar, Sherri Bracy of Bracy Consulting, LLC, answers questions surrounding compliance and Standard Operating Procedures. (Part 2 of 2)

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Addressing FDA Audit Deficiencies with a CTMS

The number one deficiency found in FDA audits of clinical research is protocol non-compliance. See how using a CTMS can help address these issues and more.

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Aiding Clinical Research Compliance With SOPs – Part I

(Part 1 of 2) In response to her recent webinar, Sherri Bracy of Bracy Consulting, LLC, answers questions surrounding compliance and Standard Operating Procedures.

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