Archives

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

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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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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Data Centers are Constantly Evolving
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Data Centers are Constantly Evolving

Growing up, we did not have a home computer in my family until I was 11 years old. We were fortunate enough that my momma...

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The Low Down on a New Packaging Serialization Standard
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The Low Down on a New Packaging Serialization Standard

Nine vendors and one end user recently conducted pilot tests to develop, evaluate, and validate a new serialization standard, PSS 1.0, officially released in November...

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Applying Six Sigma Principles to Operations: The Voice of the Customer
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Applying Six Sigma Principles to Operations: The Voice of the Customer

What is the “Voice of The Customer”? Is it only external customers? The end users? What about internal customers? Do they have a “voice” as...

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Applying Six Sigma Principles to Client Operations: Waste
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Applying Six Sigma Principles to Client Operations: Waste

Waste shows up in many forms and in all projects. This happens regardless of industry, product, or service being provided. Nothing is perfect, no matter...

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Applying Six Sigma Principles to Operations: The Cost of Poor Quality
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Applying Six Sigma Principles to Operations: The Cost of Poor Quality

The principles and methodology of Six Sigma are applicable to multiple industries and processes. In all cases, the primary reason these principles are implemented is...

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Implementing USP Visual Inspection Requirements
Blog Post

Implementing USP Visual Inspection Requirements

The word “visible” in the expression, Visual Inspection of Parenteral Products, has no meaning unless the viewing conditions are specified.  (more…)

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