Category Archives: Pharma@Risk™

#54 – REPORT HIGHLIGHTS NEED TO ADDRESS ROOT CAUSE OF R&D – CINDY FAZZI

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Cindy FazziPharmaceutical and biotechnology companies need to address the root cause of their drug development inefficiencies.  Most companies focus their efforts on “enhanced clinical trial designs” that use biomarkers and adopt advanced statistical analyses, but they still need to hone their efforts at streamlining their drug development process, according to a recent report by the Tufts Center for the Study of Drug Development. Continue reading →

#52 – FDA DISCOURAGING THIRD PARTY MDSAP – GRANT RAMALEY

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Congress has mandated that every two years the FDA will have inspected nearly every medical device manufacturer on planet Earth that sells to the United States. This isn’t happening. Some have the illusory hope that the Medical Device Single Audit Program (MDSAP) will remedy this. Continue reading →

#50 – INNOVATION AND THE QUALITY PROCESS – KEN PETERSON

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UntitledThinking 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. Continue reading →

#49 – CORRECTING AND DETECTING CAPA HORRORS – PETER KNAUER

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

The long history of Corrective and Preventive Action (CAPA) requirements within the Food and Drug Administration’s (FDA) Quality System Regulations—and specifically 21 CRF 820.100 and ICH Q10—implies that most biomedical companies have evolved a certain level of mature thinking and a good understanding of the fundamental requirements for CAPA systems.  This, unfortunately, is not always the case.  I am currently spending a lot of time working with client companies in remediation mode; that is, after FDA has found enough flaws to issue a 483 or warning letter.  I would like to point out some common CAPA problems that can be proactively rectified to avoid citations in the first place. Continue reading →

#48 – SIX WAYS TO LEVERAGE RISK – BASED MONITORING & CLINICAL CAPA – CINDY FAZZI

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Cindy FazziA 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).

This is in addition to the requirement that sponsors and CROs integrate CAPA (corrective action and preventative action) as a tool for ensuring patient safety and data integrity throughout the clinical trial. Continue reading →