Whitepaper: Funding Building Commissioning Efforts

March 14, 2019 ||
This whitepaper examines “The Capital Project Model – Limitations, Pitfalls, and Short Comings”  as it related to Building Commissioning efforts as well as “An Alternative Method – Combined Funding, Benefits, and Advantages.”   Written by Jay Congdon, CEM, CEA, CBCPM, CBCP, EBCP, CMVP Jay has 12 years of experience providing Building…

What does it take to inspire people to work safely?

January 29, 2019 ||
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 for creating and inspiring a strong safety culture… this was my response:

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

January 24, 2019 ||
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 drug into trials, and eventually to the marketplace, as rapidly as possible. Contract research organizations (CROs), contract development and manufacturing companies (CDMOs), and dedicated contract…

Whitepaper: 6 Mistakes Made When Implementing Serialization

January 22, 2019 ||
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 meant to give industry more time to comply with the new regulation, but this extra time does not modify the Act or change the enforcement…

The Top 2 Elements of FAT Planning

December 13, 2018 ||
  Your equipment is ordered.  The schedule is set.  The team travel plans are made. But are you ready to maximize your experience at the original equipment manufacturer’s factory floor?  This post will review some key points to consider in maximizing the Factory Acceptance Testing (FAT) as part of the…

Equipment Reliability and Preserving Functional Requirements

October 23, 2018 ||
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, and commissioned to a specific set of standards. There is an expectation that the equipment will continue to provide quality service within those parameters for…

Improving Supply Chain Through Human Performance

October 18, 2018 ||
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 II had – a shortage of skilled and qualified operators and technicians. This lack of a skilled workforce in the early 1940’s was a crisis…