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What does it take to inspire people to work safely?

By Michael Martin, 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:

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5 Major Factors in Choosing a Partner Firm to Help Accelerate Your Speed to Market

By David Shenberger, 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 manufacturing organizations (CMOs) all offer options for the specific expertise needed to complete the research, product development, and process development necessary to successfully manufacture a new drug entity.

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Whitepaper: Six Mistakes Pharmaceutical Companies Make When Implementing Serialization

By Brian Stephens, 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 date of its later provisions.  The extra time may seem sufficient for companies who have delayed their serialization efforts, but many companies are finding serialization to be more involved than they expected, as they encounter unforeseen issues and delays during several phases of their project.  These problems have several causes, including the immature technology being used, the miscalculation of resources required to implement the system, and the failure to identify the system’s true capabilities until it is too late.  This whitepaper discusses common mistakes made before, during, and after the implementation of a serialization system and offers ideas to minimize or eliminate the problems associated with adding serialization to a supply chain.

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Are you too busy to fix your organization's asset management problems?

By John Hughes, January 8, 2019

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The Top 2 Elements of FAT Planning

By Keith Weseli, 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 overall verification process.

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Are paper batch records slowing you down?

By Michael Morrison, November 13, 2018

How are batches managed?

 

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2018 ISPE Annual Meeting Speakers

By Jennifer Lauria Clark, November 1, 2018

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Cloud Computing in a Regulated Environment

By John Hannon, October 25, 2018

How can cloud computing be used in a highly regulated environment?

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Equipment Reliability and Preserving Functional Requirements

By John Hughes, 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 a set amount of time and for a predictable cost. Yet we struggle to have confidence that our operational and capital expenditures will return the maximum value from our assets from the day they are qualified until their disposal.

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Improving Supply Chain Through Human Performance

By Rich Tree, 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 that the U.S. Government War Production Board responded to quickly with one of the first emergency services to be established: Training Within Industry or TWI. As many skill laborers went off to war, the service was designed to boost industrial production of war material born out of the need to rapidly train new, unskilled workers entering the war production workforce. The impact of TWI was instrumental to the United States’ victory in World War II, but it also had a far-reaching impact on the post-war rebuilding of Japan. Although this program was built on long accepted principles, it was very effective because managers and supervisors were “drilled” in “how to do it."  It began with the recognition that the organizational environment and the organization’s management systems had to establish the framework by which humans are expected to succeed. TWI worked to solve a problem that the nation faced in the 1940’s by focusing on training unskilled workers and minimizing human error, and this remains the objective for the pharma and biotech workforce today.

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How to Understand ASTM E2500