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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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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
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From Dragon to Chameleon

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

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Maximizing the Impact of Factory Acceptance Testing
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Maximizing 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...

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Where to Draw the Line?
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Where to Draw the Line?

What is an appropriate level of GMPs for a supplier manufacturing site? (more…)

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Optimizing Time to Market
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Optimizing Time to Market

In the biotech industry today, mergers, acquisitions, and joint ventures are announced daily. Startup companies with viable molecules must decide early how they are going...

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All Hands Topside for Stores Load
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All Hands Topside for Stores Load

  Below are typical pictures of how food and parts are loaded on a submarine prior to deployment.  Yes, it is a very manual and...

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How do you develop your organization’s maintenance program?
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How do you develop your organization’s maintenance program?

  (more…)

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Maintenance & Reliability: Goldilocks and the Three Bears
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Maintenance & Reliability: Goldilocks and the Three Bears

Like Goldilocks, most of us are trying to find that reliability program that is “just right” for all of our equipment and processes. (more…)

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20 Years of Meeting a Higher Standard
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20 Years of Meeting a Higher Standard

Commissioning Agents, Inc. (CAI) was founded with a mission to become the world wide leader of value-added commissioning services for Biopharm facilities and to be...

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Help The OEM Help You. Better Designs From Suppliers With In Depth RFI
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Help The OEM Help You. Better Designs From Suppliers With In Depth RFI

Identifying Original Equipment Manufacturers (OEMs) with the capabilities and experience to design, build and deliver physical assets that perform beyond stakeholders’ expectations is an important...

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