Resources

Compliance and Regulatory

Latest Compliance and Regulatory Resources

The What, Why and How Behind Records Review Protocols

Join us for this informative webinar to learn what records review protocols are, why they’re important, and how to conduct them.

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Preparing for an FDA Audit? Learn How.

While FDA audits are fairly common, many researchers haven’t been through them yet. Learn what it takes to be prepared for your next audit.

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Is Your Site FDA Inspection-Ready?

Madeleine Williams and Roberta Costello will present practical tips for preparing for your next FDA audit, including real-world examples.

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The Global Future of Clinical Trials for the Medical Device Industry

London-based CRO, Richmond Pharmacology, shares what’s next for the medical device industry, including testing, licensing, and monitoring worldwide.

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Do SOPs for Data Collection Equal Compliance with 21 CFR Part 11?

Anders Lindquist clears up common confusion surrounding standard operating procedures and 21 CFR Part 11.

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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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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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