GxP Lifeline Newsletter
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December | 2017
MasterControl GxP Lifeline
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How Santa’s Kitchen Prepares for an FDA Inspection
by Marci Crane, MasterControl Staff Writer

 

In addition to the billions of toys produced annually by Mr. Santa Claus and his merry elves, there are a great deal of candy, cookies, chocolates, cakes and additional delicate treats produced in Santa’s kitchen facilities at the North Pole.

 

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Holiday Party Hosting Tip: Get an eQMS
by Cindy Fazzi

 

It’s that time of year when we get together with family and friends and enjoy holiday festivities. Sure, all the mingling and merriment of a holiday party can be fun, but organizing an event — not so much. If you happen to be the designated planner/host of your holiday soiree, you may want to consider using an electronic quality management system (eQMS).

 

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Cures Act Implementation: Gottlieb Says Faster Cancer Drug Approvals Coming for Secondary Indications
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3-D printed microfibers could provide structure for artificially grown body parts
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FDA Draft Guidance on Electronic Records and Signatures: The Next Chapter
by Betsy Fallen, BAFallen Consulting LLC

 

Just about everyone in the drug development industry has cited 21 CFR Part 11 at one time or another. Fondly referred to as “Part 11,” the August 1997 regulation was last referenced by the FDA in 2003 with the release of a Guidance for Industry - Part 11, Electronic Records; Electronic Signatures — Scope and Application.

 

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20 Years Later, 21 CFR Part 11 is More Relevant than Ever
by Cindy Fazzi, MasterControl Staff Writer

 

If 21 CFR Part 11 and the life science industry were a married couple, they would be celebrating their platinum wedding anniversary this year. For better or for worse, in sickness and in health, it has been 20 years of compliance. It’s an important milestone to celebrate and think about.

 

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