Own Who You Are: Women in Pharma
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,...
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Five Keys to Manufacturing Success
"...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...
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Training [Usually] Isn’t the Answer
How a knee jerk reaction can waste time, money, and leave the problem unsolved. (more…)
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Facilitation is the Key to Successful FMEAs
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...
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GEP In Projects – To Practice, Or Not To Practice?
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...
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I Stuck my Hand in the Stopper Bowl
A tale of why read and acknowledge is a failed method of operator training. (more…)
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The Data Life Cycle
The ISPE Good Practice Guide on Records and Data Integrity defines a data life cycle consisting of: Creation — Processing — Review, Reporting, and Use — Retention and Retrieval — Destruction A robust...
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What do NASA Missions and Pharmaceutical Manufacturing have in common?
NASA recently ended a 20 year 5-Billion-mile space journey as its Cassini space probe burned up in Saturn’s atmosphere (NASA.gov Cassini Mission Site). This $3.26...
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Are You Ready? Major Changes Coming to Europe MDR and IVDR
Introduction: One of the major focuses this year at the RAPs Convergence in DC was implementation timelines for the EU Medical Device Directive and the...
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