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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Download the Whitepaper: Power of Design Review
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Download the Whitepaper: Power of Design Review

Design Review (DR) and Quality Risk Management (QRM) are considered current industry practice and are essential as enabling processes for verification of facilities, systems, and...

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C&Q Benchmarking: Process and State of the Industry
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C&Q Benchmarking: Process and State of the Industry

Risk-based approaches to commissioning and qualification (C&Q) is a common standard for site and project plans. What does that mean and why is there so...

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Whitepaper: Strong Project Controls are Critical to Your Success
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Whitepaper: Strong Project Controls are Critical to Your Success

Here's an excerpt from this whitepaper: "The hallmark of a high performing organization is the cultivation, use, and continuous improvement of their processes used to...

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Batteries & Flywheels: What is your best energy storage option?
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Batteries & Flywheels: What is your best energy storage option?

A mission critical facility’s greatest liability to maintaining uptime is power quality. But why is power quality so important to a Data Center’s operation? Because...

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What do LEED® and CAI have in common?
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What do LEED® and CAI have in common?

Have you wondered what LEED® means, and why it has become such a widely used term? (more…)

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The Edge of Modular Data Centers
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The Edge of Modular Data Centers

The expansion of edge computing, powered by the Internet of Thing’s (IoT) uprising tide, brings the unique opportunity to turn a world full of data...

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Whitepaper: Funding Building Commissioning Efforts
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Whitepaper: Funding Building Commissioning Efforts

This whitepaper examines "The Capital Project Model - Limitations, Pitfalls, and Short Comings"  as it related to Building Commissioning efforts as well as "An Alternative...

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What does it take to inspire people to work safely?
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What does it take to inspire people to work safely?

Having led many large capital projects around the world that had very strong safety records, I was asked by an HSE leader about my approach...

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5 Factors in Choosing a Partner Firm to Accelerate Speed to Market
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5 Factors in Choosing a Partner Firm to Accelerate Speed 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 get a...

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Whitepaper: 6 Mistakes Made When Implementing Serialization
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Whitepaper: 6 Mistakes Made When Implementing Serialization

The FDA’s 12 month delay in enforcing the Drug Supply Chain Security Act (DSCSA) requirement for all RX products in cases to be serialized was...

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