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...
Read MoreI Stuck my Hand in the Stopper Bowl
A tale of why read and acknowledge is a failed method of operator training. (more…)
Read MoreThe 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...
Read MoreWhat 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...
Read MoreAre 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...
Read MoreSpare Parts: The Hidden Cost of Maintaining Equipment
If you own or manage any equipment, you maintain an inventory of spare parts. How have you determined what to keep in your warehouse?...
Read MoreFrom Dragon to Chameleon
Implementing a Serialization Database Across an Entire Enterprise. (more…)
Read MoreMaximizing the Impact of Factory Acceptance Testing
Your equipment is ordered. The schedule is set. The team travel plans are made. But are you ready to maximize your experience at the...
Read MoreWhere to Draw the Line?
What is an appropriate level of GMPs for a supplier manufacturing site? (more…)
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