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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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?

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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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Serialization: Are You Ready For Changing Regulations?
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Serialization: Are You Ready For Changing Regulations?

If the pharmaceutical distribution network is at risk, so is patient safety. With counterfeit drugs on the rise, serialization programs are being implemented to safeguard the...

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Do You Have Rouging Problems?
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Do You Have Rouging Problems?

Recently rouging of two process vessels at a blood fractionation facility shut down production.  The tanks of concern were derouged and passivated just 10 days...

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