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James Francum

Recent Posts

How to Avoid Pharmaceutical Data Integrity Issues

January 22nd, 2016 by James Francum

In 2015, the US Food and Drug Administration (USFDA) issued Warning Letters to. [...] Read More

Posted in Pharmaceutical Data Integrity

Complying with eMDR FDA Regulations

August 14th, 2015 by James Francum

In February of 2014 the Food and Drug Administration (FDA) published the final. [...] Read More

Posted in HL7ACSR

Anticipating FDA Initiatives for Risk Management

May 6th, 2015 by James Francum

Regulatory bodies like the FDA enact initiatives on a routine basis. While. [...] Read More

Posted in Risk Management

How Cybersecurity Impacts Device Producers

April 9th, 2015 by James Francum

The FDA can be slow to change its ways, but its guidelines aren't immutable. As. [...] Read More

Posted in quality management devices

Will 21 CFR 11 Hinder My Compliance Efforts?

March 31st, 2015 by James Francum

Electronic records are complex by nature. While they ostensibly serve as. [...] Read More

Posted in FDA regulations

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

March 3rd, 2015 by James Francum

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

Posted in Monica Cahilly

Good Pharmacovigilance Practices: Open the Doors to the EU

February 10th, 2015 by James Francum

The pharmaceuticals you manufacture have massive potential. On one hand, they. [...] Read More

Posted in GxP CC

Dr. Simone Peschl Named GxP-CC Operations Manager

December 12th, 2014 by James Francum

GxP-CC is delighted to announce the addition of Dr. Simone Peschl as the. [...] Read More

Posted in Medical Device Compliance

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

December 2nd, 2014 by James Francum

Where's the weakest link in your compliance mechanism? While you may be well. [...] Read More

Posted in Supply Chain

Validated Cloud Computing in Today’s Regulated Environments

October 10th, 2014 by James Francum

Adopting cloud-based technologies is a common step for growing firms, but those. [...] Read More

Posted in GxP CC

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