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Featured Articles

November 2010

Dr. George L. Harris

19 Key Elements to Review for Effective Audits

  by Dr. George L. Harris
  DBA, CPM, CPCM, President, Calyptus Group

Manufacturing organizations on a global scale have instituted ways of qualifying suppliers to ensure that their capabilities have been verified. The types of qualification methods used are multifold. Some include quality and business system components that are essential for effective production or service rendering. Others may simply focus on quality characteristics, and still others may only consider production and equipment capabilities. More effective methods, however, include a combination of business, production, service, and quality factors to provide a holistic impression of the supplier's organization. These factors play a critical role in providing excellent customer service.

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Nancie Celini

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

  by Nancie E. Celini
  GxP, 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.

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ISPE Annual Meeting
November 7-10, 2010, Orlando, FL

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Do you know what 'readily available' means in the context of 21 CFR Part 11 documentation? If you're familiar with 21 CFR Part 11 documentation you may have wondered what "ready available" means. Or perhaps you've also wondered what "instantly" refers to in the same context. According to Labcompliance News, it's these phrases that keep regulated companies guessing.
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