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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.

Root Cause Analysis as a Tool for CAPAs

September 12th, 2014 by

CAPA Root Cause AnalysisCAPAs, or Corrective and Preventive [...] Read More

Harmonization Processes Through ICH  

September 3rd, 2014 by

ICH Harmonization ProcessThe methodologies your firm employs [...] Read More

What Color Pen Can I Use to Sign Documents?

August 14th, 2014 by

Ink Color for Signing Documents[...] Read More

Principles of Quality Risk Management: Implementing ICH Q9

July 17th, 2014 by

ICH Q9 Risk ManagementAs you make efforts to adhere to guidelines and regulations [...] Read More

Getting Compliant With FDA 21 CFR Part 11

July 7th, 2014 by

FDA 21 CFR Part 11The FDA requires medical device manufacturers, pharmaceuticals manufacturers, [...] Read More

Clarifying the Difference in Equipment Qualification and Process Validation

June 10th, 2014 by

Process ValidationHow do you know your life sciences firm is maintaining compliance? While FDA audits and [...] Read More

Improving CAPA in the Regulated Industries

May 29th, 2014 by

CAPA SystemCorrective and preventive actions, or CAPAs, play a vital role in how GxP firms maintain compliance with FDA standards. A corrective action (CA) is an action [...] Read More

Improve Record Keeping With 21 CFR Part 11

May 20th, 2014 by

Electronic SignatureElectronic record [...] Read More

GxP-CC Earns ISO 9001:2008 Certification

May 8th, 2014 by

ISO 9001:2008 Certified IQNetGxP-CC has achieved ISO 9001:2008 certification. Developed by the International Organization [...] Read More

Staying Up-To-Date With FDA Pharmaceutical cGMPs

May 5th, 2014 by

Pharmaceutical cGMPYour firm’s pharmaceutical products aren’t the only things subject to U.S. and international regulations. For decades, agencies like the FDA have also required manufacturers to adhere to a range of best practices that include management of production facilities and supply [...] Read More