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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What is Proactive Commissioning?
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What is Proactive Commissioning?

In Maintenance and Reliability, there are a complete set of tools dedicated to Proactive Maintenance.   (more…)

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Predictive Maintenance Technologies
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Predictive Maintenance Technologies

Predictive Maintenance (PdM) technologies are not just for use after your equipment has been installed.  Many of these technologies can be applied during the various...

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Human Error and Uncertainty
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Human Error and Uncertainty

Why competent people make costly errors, and how to address it. (more…)

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Commissioning Teamwork
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Commissioning Teamwork

How to best develop good teamwork across the General Contractor, subconsultants, CxA, and Operations during a project. (more…)

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Why Implement Total Productive Maintenance Autonomous Maintenance
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Why Implement Total Productive Maintenance Autonomous Maintenance

  (more…)

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E-Pub: The Importance of Annex 1
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E-Pub: The Importance of Annex 1

Annex 1 - "Manufacture of Sterile Medicinal Products." was first published in 1971. However, the first revision since then is currently in process. And this...

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Why I Chose CAI to Incubate and Accelerate my Career
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Why I Chose CAI to Incubate and Accelerate my Career

I have two guiding principles that I rely on when making career decisions. Compounding experience and future opportunity. (more…)

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Moving the Goalposts?
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Moving the Goalposts?

Can a standard Corporate Scoring Framework be applied across the spectrum of Quality Risk Management? (more…)

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Int’l Women’s Day: An Open Letter to my Most Inspirational Colleague
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Int’l Women’s Day: An Open Letter to my Most Inspirational Colleague

Have I ever told you how much I want to be just like you? I am so thankful for the opportunity to work alongside the...

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In Review: Facilities of the Future Conference
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In Review: Facilities of the Future Conference

ISPE held its second Facilities of the Future conference.  The conference brought together over 160 professionals from pharmaceutical and biotech manufacturing, equipment suppliers, academics, and...

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