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Blog

The Most Important Thing That You Don’t Think Affects You!

By Lou Traglia, November 10, 2017

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Is Rework Killing Your Packaging Line Efficiencies?

By Tammy Little, November 7, 2017

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Let Others Make the Mistakes – It is More Efficient

By Glenn Wallace, November 2, 2017

Lessons Learned in Construction

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First 100 Days of a Capital Project

By Bill Deckert, October 31, 2017

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Own Who You Are: Women in Pharma

By Jennifer Lauria Clark, October 27, 2017

On Sunday I will have the pleasure of facilitating a spotlight session on “The Women in Pharma” at the ISPE Annual Meeting in San Diego, California.  We will be meeting from 1415 – 1515 to participate in round table discussions focusing on ourselves.  We will cover topics on leadership, higher education, technical aptitudes, and others that will help you evaluate your current position through your journey of professional and personal growth.  Each of our round tables will answer different questions, but this one will be asked at every table – “What guides your approach to leadership, and how do you encourage your team to be motivated and inspired?”

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Five Keys to Manufacturing Success

By R. J. Filannino, October 26, 2017

"...there are five dominant management systems required to achieve manufacturing performance.... Each element drives an important priority within the organization. An imbalance in any direction will create a gap and introduce unnecessary organization variation, impacting product quality."

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Training [Usually] Isn't the Answer

By Daisy Chew, October 24, 2017

How a knee jerk reaction can waste time, money, and leave the problem unsolved.

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Facilitation is the Key to Successful FMEAs

By Robert Smith, October 19, 2017

The Failure Modes and Effects Analysis (FMEA) is a versatile risk management tool that has been around for several decades, first used by the US Armed Forces in 1949. It started gaining popularity in the 1960’s with its use in the aerospace industry during the Apollo missions. FMEA has been called the “swiss army knife” of risk management. FMEA is focused on problem prevention, rather than problem solving. It is used to identify the factors that can lead to failure and recommend mitigation strategies to prevent failures or detect the early onset of failures.

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GEP In Projects – To Practice, Or Not To Practice?

By Bob Perry, October 17, 2017

As responsible Project Managers, we need to deliver maximum benefits realization to our project stakeholders on each project.  The key to maximum benefits realization is clearly delineating stakeholder requirements and assuring these requirements are satisfied throughout the project lifecycle.  A critical component for assuring stakeholder requirements are satisfied is following good engineering practice (GEP).  While GEP is an expectation in the life sciences industries, the basic GEP elements required as a basis for GxP (good “anything” practice) quality guidelines and regulations compliance can, and should be, applied to all projects.

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I Stuck my Hand in the Stopper Bowl

By Daisy Chew, October 12, 2017

A tale of why read and acknowledge is a failed method of operator training.

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How to Understand ASTM E2500