Blog

News

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 Letters to eight pharmaceutical companies for the lack of data integrity. According to the USFDA, data integrity means, “presence of accurate and reliable data in an application submitted to the [...] Read More

Complying with eMDR FDA Regulations

August 14th, 2015 by

Medical Lab TechnicianIn February of 2014 the Food and Drug Administration (FDA) published the final rule that all major importers as well as foreign and domestic manufacturers of medical devices must submit their medical [...] Read More

Anticipating FDA Initiatives for Risk Management

May 6th, 2015 by

Guidelines Rules and ComplianceRegulatory bodies like the FDA enact initiatives on a routine basis. While their timing [...] Read More

How Cybersecurity Impacts Device Producers

April 9th, 2015 by

Laptop & StethoscopeThe FDA can be slow to change its ways, but its guidelines aren’t immutable. As new technological concerns arise, the agency adapts its suggestions on how medical device manufacturers should respond, and [...] Read More

Will 21 CFR 11 Hinder My Compliance Efforts?

March 31st, 2015 by

Electronic Records ManagementElectronic records are complex by nature. While they ostensibly serve as evidence of compliance efforts and regulatory adherence, [...] 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 Training Program in San Diego, CA, including a Train-the-Trainer session. The training entailed all aspects of regulatory requirements and perspectives concerning Data Integrity in the Life [...] Read More

Good Pharmacovigilance Practices: Open the Doors to the EU

February 10th, 2015 by

EU Good Pharmacovigilance PracticesThe pharmaceuticals you manufacture have massive potential. On one hand, they could represent a vital cure for struggling patients, but they [...] Read More

Dr. Simone Peschl Named GxP-CC Operations Manager

December 12th, 2014 by

GxP-CC Hires Dr. Simone PeschlGxP-CC is delighted to announce the addition of Dr. Simone Peschl as the company’s new Operations [...] 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 your compliance mechanism? While you may be well aware of the most problematic areas in the facilities you’re personally responsible for, supply chain compliance deficiencies have a way of sneaking up on [...] Read More

Validated Cloud Computing in Today’s Regulated Environments

October 10th, 2014 by

FDA Cloud Computing ValidationAdopting cloud-based technologies is a common step for [...] Read More