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
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
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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The Top 2 Elements of FAT Planning
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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Cloud Computing in a Regulated Environment
How can cloud computing be used in a highly regulated environment? (more…)
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Equipment Reliability and Preserving Functional Requirements
Pharmaceutical companies make huge investments in equipment, materials, and personnel to develop and manufacture life-saving products. The equipment that makes those products is designed, manufactured,...
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Improving Supply Chain Through Human Performance
In many ways, today's pharma and biotech facilities share the same problem that many of the factories that supported the war effort during World War...
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Does your project team have a common vision and goal?
Sometimes projects are conducted as a series of disconnected efforts where each team from planning, design, construction, and testing views themselves as separate entities. With...
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