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Blog

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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Does your project team have a common vision and goal?

By Michael Martin, October 16, 2018

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 each trying to finish their portion of the work and get on to their next project. These “separate” efforts have goals to accomplish, and sometimes they regard each other as the obstacle to accomplishing those goals. The downstream team often feels that the upstream team doesn’t understand the difficulties they are experiencing and that they are just trying to throw the work product over the wall and claim success. The upstream team feels that the downstream team is too demanding and will not accept something less than perfection. Conflict ensues, and the overall program suffers. 

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AAV Vector Production

By Robert Ossig, September 4, 2018

Overview

Until about 2016, the majority of vectors used in gene therapy were Adenovirus and Retrovirus vectors.  In recent years, a change toward Lentivirus and Adeno-associated virus (AAV) vectors has occurred.  This is reflected when looking at the numbers in current clinical trials underway in the gene therapy field.

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Empowering Your Operators to Lead Can Reduce Losses

By Rick Jones, July 5, 2018

 

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Visit us at Table 9 at PDA EU Annual Meeting

By John Henchion, June 22, 2018

 

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What is Proactive Commissioning?

By Glenn Wallace, June 7, 2018

In Maintenance and Reliability, there are a complete set of tools dedicated to Proactive Maintenance.

 

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How to Understand ASTM E2500