Monthly Member Gift March 2014

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Welcome to Your Free Monthly Gift Package from ISPE

Gift #1:

Pharmaceutical Engineering May/June Issue Preview: "Defining Holistic Asset Criticality to Manage Risk"
by David J. Mierau, PE, CMRP, Sr. Reliability Engineering SME, Life Cycle Engineering
Download the Article ( 1 MB)

The pharmaceutical and biotech industries have a wealth of information related to risk-based practices for validation, qualification and commissioning of processes and equipment. These approaches typically focus on the impact of an asset to product or raw material Strength, Identity, Purity and Quality (SISPQ). However, there is also significant value in understanding the holistic potential impact an asset carries. 

This article illustrates how risks to safety, quality and productivity can be managed through asset control strategies, which are created based on specific asset criticality and failure modes.

Gift #2:

"Statistically Determined Acceptance Criteria and Sampling Plans for PPQ"
by Mark D. Johnson, Principal Research Statistician, AbbVie, Inc.
Download Presentation ( 1 MB)

In the FDA's Process Validation Guidance from January 2011, the concept of "statistics" is mentioned 15 times, showing that more statistical thinking is expected in validation. This presentation, from the 2013 ISPE Process Validation Conference, explores how statistics can result in a higher degree of assurance that a high percentage of the population is within specification and a population parameter is within specification. This topic will also be discussed during the upcoming ISPE Statistician Forum.

If you have feedback regarding your monthly gift from ISPE, including suggestions for future content, please contact Debra Sher at Don't forget to review your Member Benefits on a regular basis to stay current and make the most of your membership!

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