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James Francum

Recent Posts

Harmonization Processes Through ICH  

September 3rd, 2014 by James Francum

Harmonization Processes Through ICH   The methodologies your firm employs in the creation of pharmaceuticals,. [...] Read More

Posted in Quality Risk Management System

What Color Pen Can I Use to Sign Documents?

August 14th, 2014 by James Francum

What Color Pen Can I Use to Sign Documents? Not sure which pen to use? Although it seems like an amusing topic, your choice. [...] Read More

Posted in Pen Colors for Signing Documents

Clarifying the Difference in Equipment Qualification and Process Validation

June 10th, 2014 by James Francum

Clarifying the Difference in Equipment Qualification and Process Validation How do you know your life sciences firm is maintaining compliance? While FDA. [...] Read More

Posted in Quality Management System

FDA Demands Full Compliance With GMP Requirements in the Pharmaceutical Industry – To What Extent Is Compliance Required?

March 12th, 2014 by James Francum

FDA Demands Full Compliance With GMP Requirements in the Pharmaceutical Industry – To What Extent Is Compliance Required? The most succinct answer to the question of what determines FDA compliance with. [...] Read More

Posted in Medical Device and Pharmaceutical Production Facil

The European Medical Device Directive As It Compares To 21 CFR 820

March 10th, 2014 by James Francum

The European Medical Device Directive As It Compares To 21 CFR 820 The European Medical Device Directive or 93/42/EEC regulates which medical. [...] Read More

Posted in QSR