Compliance Perspectives

We've created this blog to share our perspective on happenings and trends in the pharmaceutical, device, and supplement industry. We welcome your feedback.

Monday, August 19, 2019

Clinical Trial Tips: Practical and Actionable

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Over the years, attendees of MAGI Clinical Research Conferences have collected a set of practical, actionable suggestions for improving clin...

Monday, June 10, 2019

Getting The Most From Your GMP Supplier Audit

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Guest Blogger: Greg Weilersbacher Founder & President, Eastlake Quality Consulting All companies outsource. It’s a humbling fact th...

Monday, March 11, 2019

When Sites, eSystems, and Inspections Meet

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Q: Do study site personnel need to be able to answer questions about sponsor-provided computer systems during an inspection? A: Yes, and t...

Sunday, December 9, 2018

FDA Puts Santa on the Naughty List!

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WARNING LETTER VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED December 1, 2018 Mr. Kris Kringle, Owner Santa’s...

Monday, October 15, 2018

The One-Hour Study Site Audit

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In an effort to tease out the priorities of a clinical study site audit, I asked six of our most experienced GCP auditors the following qu...

Monday, August 13, 2018

What Suprises GCP Auditors?

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Last month, I scheduled one-on-one discussions with our most experienced GCP auditors to ask each of them the same question: What surprise...

Tuesday, July 10, 2018

Hackin' the GDPR

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Trying to comply with the GDPR got you down? Maybe our parody will cheer you up. (Sung to the tune of Lennon-McCartney's "Back i...

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