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Featured Articles

October 2010

Nancie Celini

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

by Nancie E. Celini
GxP, Learning Program Lead

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.

FDA has (and will) cite companies for deficiencies in their training programs. U.S. regulations can be broad and subject to loose—and often incorrect—interpretations. The regulations stipulate that personnel must have "training and education and/or experience" to enable them to fulfill their role. In today's dynamic e-clinical environment where many functions are virtual and rely upon third parties, this phrase takes on new meaning.

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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.

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Did you know that compliance issues within industry (in relation to 21 CFR Part 11 standards) are leading the FDA to conduct inspections specific to Part 11? The inspections are due to occur "soon" according to an announcement made by FDANews and the inspections are expected to lead to 1) additional guidance, 2) an amendment(s) to the Part 11 regulatory text, or 3) both.
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