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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

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

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 ResponseSo you’ve received an FDA Form 483, but you were prepared. You completed a productive inspection close-out meeting and gained [...] Read More

The Applicable Scope of FDA 21 CFR Compliance

September 9th, 2014 by

Electronic SignaturesRegulatory compliance is important for any life-sciences firm, but the breadth of your responsibilities won’t always be immediately clear. For instance, you may be well aware of the fact that 21 CFR Part 11 [...] Read More

Understanding Your Manufacturing with Critical Process Parameters

August 28th, 2014 by
Critical Process Parameters

Improve Manufacturing with CPPs

One of the biggest stumbling blocks standing [...] Read More

What Color Pen Can I Use to Sign Documents?

August 14th, 2014 by

Ink Color for Signing DocumentsNot sure which pen to use? Although it seems like an amusing topic, your choice of writing utensil actually does make a difference when you’re dealing with FDA [...] 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 created by diverse international bodies, you may find your firm pursuing numerous paths to compliance simultaneously. While there’s nothing wrong with taking specific approaches to each relevant quality [...] 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 companies, biologic developers, and other FDA-regulated industries to comply with their regulations and implement controls.

These controls should also [...] 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 assessments, Failure Mode and Effects Analysis (FMEA) methodology has become essential for medical device manufacturers. Firms that want to market products intended for human use must provide some assurance that these [...] Read More