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Anticipating FDA Initiatives for Risk Management

May 6th, 2015 by

Guidelines Rules and Compliance[...] Read More

Good Pharmacovigilance Practices: Open the Doors to the EU

February 10th, 2015 by

EU Good Pharmacovigilance Practices[...] Read More

Choosing the Most Effective IT Infrastructure Qualification Strategies

January 27th, 2015 by

IT Infrastructure Qualification Strategies[...] Read More

What Happens After Your FDA Form 483 Response Submission?

November 26th, 2014 by

FDA Warning Letter Form 483 Response[...] Read More

The Applicable Scope of FDA 21 CFR Compliance

September 9th, 2014 by

Electronic SignaturesRegulatory [...] Read More

Understanding Your Manufacturing with Critical Process Parameters

August 28th, 2014 by

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, biotech [...] Read More

FMEA Methodology As It Relates To The FDA And Medical DevicesĀ 

June 6th, 2014 by

FMEA for Medical DevicesAlthough it was originally developed for high-risk military [...] Read More