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Blog » Archive by category "compliance consultants"

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

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

Choosing the Most Effective IT Infrastructure Qualification Strategies

January 27th, 2015 by Henry Macartney

Are you sure your IT infrastructures are fully qualified, or is it possible. [...] Read More

Posted in Software Validation

What Happens After Your FDA Form 483 Response Submission?

November 26th, 2014 by Henry Macartney

So you've received an FDA Form 483, but you were prepared. You completed a. [...] Read More

Posted in Quality Management Systems

The Applicable Scope of FDA 21 CFR Compliance

September 9th, 2014 by Zuhdi Hussein

Regulatory compliance is important for any life-sciences firm, but the breadth. [...] Read More

Posted in GxP CC

Understanding Your Manufacturing with Critical Process Parameters

August 28th, 2014 by Zuhdi Hussein

Improve Manufacturing with CPPs [...] Read More

Posted in process validation

What Color Pen Can I Use to Sign Documents?

August 14th, 2014 by James Francum

Not sure which pen to use? Although it seems like an amusing topic, your choice. [...] Read More

Posted in Pen Colors for Signing Documents

Principles of Quality Risk Management: Implementing ICH Q9

July 17th, 2014 by James Francum

As you make efforts to adhere to guidelines and regulations created by diverse. [...] Read More

Posted in Quality Risk Management

Getting Compliant With FDA 21 CFR Part 11

July 7th, 2014 by James Francum

The FDA requires medical device manufacturers, pharmaceuticals manufacturers,. [...] Read More

Posted in Software and IT Systems Validation

FMEA Methodology As It Relates To The FDA And Medical Devices 

June 6th, 2014 by Zuhdi Hussein

Although it was originally developed for high-risk military assessments,. [...] Read More

Posted in Risk Management System

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