Archives

Planning for a Talented Workforce: Building a Staffing Plan for New or Expanding GMP Facilities
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Planning for a Talented Workforce: Building a Staffing Plan for New or Expanding GMP Facilities

Let’s contrast two very real scenarios: You are responsible for bringing a new GMP facility or line to full-scale production. Your board or shareholders expect...

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Five Keys to Manufacturing Success
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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
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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
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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?
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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
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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
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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?
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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
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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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Spare Parts: The Hidden Cost of Maintaining Equipment
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Spare 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?...

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From Dragon to Chameleon
Blog Post

From Dragon to Chameleon

Implementing a Serialization Database Across an Entire Enterprise. (more…)

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