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About this author:

James Francum

For over 15 years Mr. Francum has worked in regulated environments directing and orchestrating the various components involved in assuring compliance of the most stringent regulatory requirements. He is an internationally recognized expert and has extensive experience in over 25 countries including, but not limited to, the regions of North America, Latin America, Europe and the Middle East.

How to Avoid Pharmaceutical Data Integrity Issues

January 22nd, 2016 by

Pharmacists in LabIn 2015, the US Food and Drug Administration (USFDA) issued Warning [...] Read More

Complying with eMDR FDA Regulations

August 14th, 2015 by

Medical Lab TechnicianIn February of [...] Read More

Anticipating FDA Initiatives for Risk Management

May 6th, 2015 by

Guidelines Rules and Compliance[...] Read More

How Cybersecurity Impacts Device Producers

April 9th, 2015 by

Laptop & StethoscopeThe FDA can be [...] Read More

Will 21 CFR 11 Hinder My Compliance Efforts?

March 31st, 2015 by

Electronic Records Management[...] Read More

GxP-CC Completes GMQA’s Electronic Data Integrity Certification Training

March 3rd, 2015 by

Data Integrity Compliance TrainingTeam members of GxP-CC consultants have completed the full session of the Data Integrity [...] Read More

Good Pharmacovigilance Practices: Open the Doors to the EU

February 10th, 2015 by

EU Good Pharmacovigilance Practices[...] Read More

Dr. Simone Peschl Named GxP-CC Operations Manager

December 12th, 2014 by

GxP-CC Hires Dr. Simone Peschl[...] Read More

What Role Will Supplier Audits Play in Your Supply Chain’s Integrity?

December 2nd, 2014 by

Supplier AuditsWhere’s the weakest link in [...] Read More

Validated Cloud Computing in Today’s Regulated Environments

October 10th, 2014 by

FDA Cloud Computing Validation[...] Read More