• What’s in Your Training Toolkit?

    29 January, 2014 David Hofstetter, Manager, Learning and Development at New England Organ Bank

    Do we do a good enough job at identifying the real issue or are we in such a hurry to meet a requested deadline that we simply take the word of the requestor? How do we know we are truly solving the issue and not just meeting a request? 

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  • 6 Ways to Leverage Risk-Based Monitoring & Clinical CAPA

    14 November, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    A big part of the cost of developing a new drug can be attributed to clinical research, which typically lasts at least eight-and-a-half years.  For this reason, regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are emphasizing the need to mitigate clinical-trial risks (1).

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  • Innovation and the Quality Process

    8 October, 2013 Ken Peterson, Director of Quality and Consultation Services, MasterControl Inc.

    Thinking of new ideas and putting those ideas to practical economic use can be more of an art than a science. At times innovation sends a signal that is in opposition to quality. If we are constantly trying to solve problems and find solutions through effective investigation of failures, do we ever consider that the best solution is to ignore the past and invent the future? Those of us who have a wider view of what innovation should deliver seek entirely new approaches verses conventional problem-solving for cause. It’s not that analytical thinking is unnecessary but on occasion, a new solution unrelated to cause removal is warranted.

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  • Three Quality Management Tips to Avoid Death by CAPA - for Medical Devices Industry

    17 April, 2017 Ken Peterson

    It's been 10 years since the FDA introduced a regulation requiring that medical device manufacturers implement a formal corrective and preventive action (CAPA) system to monitor and manage the safety complaints associated with their products. Yet, managing a CAPA system remains a major challenge for many manufacturers.A sound CAPA system organizes and evaluates complaints, nonconformances, and other deviations about products and services to improve patient safety. But the problem is: How do you

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  • Medical Device Firms Experiencing 'Death by CAPA?'

    1 March, 2008 MasterControl

    Eighty-eight percent of all Warning Letters issued by the FDA to medical device firms recently were related to CAPA deficiencies. Managing the CAPA process is a major challenge for most medical device companies. This problem can be so overwhelming that an FDA official called it "death by CAPA."Is your CAPA system helping or "killing" your organization? In the next issue, an article by Ken Peterson, senior partner of PathWise Inc., a leading CAPA training and consulting provider, will examine ris

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  • Essential Elements of Effective CAPA Systems - Death by CAPA

    14 April, 2017 Ken Peterson, PathWise Inc.

    The end result objective of a corrective and preventative action (CAPA) is, quite simply, a solution to the issue from which the CAPA was generated. If it is not driving toward a solution, a CAPA is a waste of time and resources. For organizations in regulatory environments, CAPA is an overarching umbrella—all control points flow through to the CAPA system.

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  • Clinical CAPA: CAPA Isn't Just for Manufacturing Anymore

    22 March, 2012 Patricia Santos-Serrao, Senior Product Manager, Pharmaceutical Industry, MasterControl, Inc.

    Note: The views expressed in this article are those of the author and do not necessarily represent those of her employer, GxP Lifeline, its editor or MasterControl, Inc.

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  • Peeling the Onion to Improve Human Reliability

    11 December, 2012 Stacy Berkshire, Senior Director of Global Quality Programs, Perrigo Company

    Humans will make mistakes. Industries have been focusing on strategies to reduce or even eliminate human error in efforts to keep consumers and employees safe. Pharmaceutical companies are responsible for ensuring that their products are safe, labeled correctly, have the correct strength, are pure, and are produced with good quality. In the pharmaceutical industry when deviations are identified as a result of an error, organizations follow a deviation investigation process to understand the root cause and put in a corrective action to fix the problem.

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