GxP Lifeline Blood & Biologics Publication Click to visit GxP Lifeline Home Click to visit mastercontrol.com

Featured Articles

July - September 2011

David Dills

Writing and Enforcing Your SOPs for GxP Compliance Success

by David R. Dills
Quality & Compliance Advisor

"Say what you do, do what you say and be able to prove it."

This paper addresses the fundamentals of writing and enforcing your SOPs not only for compliance and in accordance with internal company policies and requirements but certainly for ensuring compliance with FDA requirements as well.

Typical definitions include the procedures and processes that you utilize and operate under. These procedures and processes have been standardized to ensure they are done the same way every time. A "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function."

Read more

Jon Nugent

How to Build a Business Case for a Quality Management System

by Jon Nugent
Managing Director of Client Services, Business Intelligence Solutions

It is impossible for FDA-regulated manufacturers to conduct business without paying close attention to regulatory compliance.

FDA regulations can introduce increasing complexity into internal business processes, delaying the pace of innovation and new product introduction. And complying with regulations is expensive, with the cost of compliance now estimated at two percent of revenues. The expense, however, pales in comparison to the potential costs and risks associated with non-compliance.

Read more


Featured Webinar:

Featured White Paper:

Previous Newsletters:

Watch Customer Videos

View Upcoming Events

Did You Know?

Quality Event Management Audit Workshops
August - October 2011, Various Locations

Quality Event Management CAPA Workshops
August - October 2011, Various Locations

AABB Conference
October 22-25, 2011, San Diego, CA

RAPS Annual Conference and Exhibition
October 23-26, 2011, Indianapolis, IN

View More Events

Do you know how to navigate the FDA's website when searching for FDA warning letter information? During the (ACRP) conference it became apparent that many people, including FDA employees, have a difficult time searching for warning letters on FDA's website. In fact, it was apparent that the warning letter section of the website was an absolute mess!
Read More