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Upcoming Speaking Engagements: Operational Excellence through Preventive Human Performance Controls

By Harry Benson, March 8, 2019

Human error is inevitable, but root cause analysis of issues tells us that there are risk control elements which can reduce human error and mitigate the impact when it does occur. Although the need to reduce human error is apparent, and is frequently discussed in our industry, very little has been presented regarding actionable control strategies, or to make the business case for implementing these preventive actions.  While most of us recognize the need for controls like effective procedures and training, we don’t always appreciate how those two elements integrate with the other critical controls to drive predictable human performance.

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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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How to Understand ASTM E2500