GxP Lifeline Medical Device Publication Click to visit GxP Lifeline Home Click to visit mastercontrol.com

Featured Articles

September 2010

Nancie Celini

Transforming Training into Learning: The Importance of a Comprehensive GxP Learning Program - Part 2

by Nancie E. Celini
Learning Program Lead

In the previous article I discussed the use of the acronym "GxP" as well as regulations, a changing industry landscape and some suggestions for becoming a learning organization. In this article we will look at learning and why having a strategy, leadership and a comprehensive program is so important in our work and to our future success.

Sponsor organizations have traditionally relied upon a "Read and Understood" approach for instructing its workforce on procedural documents (e.g. Policies, SOPs, working instructions). While this may be a reasonable approach for certain procedures, this method can be unreliable. Reading procedures alone, without additional context and details may leave an organization vulnerable. Employees need to fully understand their job roles and responsibilities in context; they also need to understand the regulations that keep the organization compliant.

Read more

Mark Kaganov

ISO Standards: Quality Objectives and Quality Dreams

by Mark Kaganov
Director of Quality Operations, Quality Works

Through my consulting and auditing career I have been collecting "the best and the worst" samples of management systems and QMS documentation. Among those collectibles, here are a few examples of the worst-documented quality objectives that I have seen thus far:

  • "...to deliver exceptional values through trust of the people around the world"
  • "...conduct business better, simpler, faster"
  • "...quality is paramount and all our employees are committed to quality."

Regretfully, these "quality objectives" are straight from the documentation of some of the organizations and professionals with whom I have worked. How companies could measure performance against such "objectives" is anybody's guess. I may be overly sensitive to vague and uncertain goals because I've had several bad experiences with such "objectives" in the past.

Read more


Featured Webinar:

Featured White Paper:

Previous Newsletters:

Watch Customer Videos

View Upcoming Events

Did You Know?

MasterControl CAPA Workshop & Regulatory Session
September 15-16, 2010, Newport Beach, CA

AdvaMed Annual Congress
October 18-20, 2010, Washington D.C.

RAPS Annual Conference & Exhibition
October 24-27, 2010, San Jose, CA

MasterControl CAPA Workshop & Regulatory Session
October 27-28, 2010, San Francisco, CA

BARQA Annual Conference
November 2-5, 2010, Leeds, UK

View More Events

Did you know that in 2011 the FDA is going to be targeting Part 11 compliance more closely? Why target adherence to Part 11 requirements? The truth is that over the past few years, Part 11 requirements, which were first established in 1997, haven't taken a tremendous amount of precedence during FDA inspections. This was partially due to the controversial nature of the creation of the Part 11 standards.
Read More