ARTICLES BY MARK DURIVAGE

  • Remote Auditing Best Practices For GMP Compliance

    Every organization that is regulated by the FDA has been adversely affected by the coronavirus (COVID-19) pandemic. This article will focus on remote auditing for good manufacturing practice (GMP) compliance, with a focus on the challenges, opportunities, and best practices for performing remote internal and external audits.

  • A SMART Approach To CAPA Effectiveness Checks

    Many times, corrective and preventive action (CAPAs) fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. This article will look at using the SMART (specific, measurable, achievable, relevant, and time-bound) methodology for use in developing a CAPA verification of effectiveness plan.

  • The 10 Phases Of An Effective CAPA

    Corrective and preventive action (CAPA) issues continue to be one of the top Form 483 observational findings by the FDA. Many times, CAPAs fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. A poor paper-based CAPA process will not improve with an electronic-based CAPA system.

  • Packaging Good Manufacturing Practices (GMPs) For Medicinal Products

    Has your primary packaging materials supplier established, implemented, and maintained an adequate quality management system? The requirements of ISO 9001 may not provide the necessary levels of GMPs and rigor to ensure the packaging materials are adequate for their intended use.

  • Design Of Experiments 101: Understanding DOE’s Foundational Elements

    DOE is a very powerful tool that can be used to characterize a process. This article discusses several types of experiments, as well as the basic statistical tools and techniques, that can be used when performing a DOE.

  • Process Characterization: The Foundation For Validation

    Process validation should never be performed until the process is fully characterized. A failed process validation should be a rare event; otherwise, a Warning Letter will probably be in your future.

  • An Introduction To Sampling Plans

    Sampling plans are used extensively throughout organizations regulated by the FDA. Most have a statistical procedure that specifies a certain acceptable quality level based on risk. (If not, they should!) However, most  follow the requirements of the procedure without fully comprehending how sampling plans actually work. This is why you should.

  • Is Your Personnel Hygiene Plan Up To Date?

    Every organization that is regulated by the FDA must consider sources of contamination and cross-contamination in their manufacturing operations. A robust personnel hygiene program is an important element for good manufacturing practices (GMPs) necessary to prevent contamination and cross-contamination, in order to ensure the safety of medicinal products.

  • How To Prepare For An FDA Inspection

    An FDA inspection is very different than an ISO certification or surveillance audit — too often, organizations “prepare” for scheduled ISO audits by playing catch-up on activities that have been neglected or otherwise overlooked. The catch-up strategy will be problematic for FDA inspections.

  • Military Tool For Vulnerability Assessment: The CARVER + Shock Technique

    CARVER + Shock is a vulnerability assessment tool that can help manufacturers of medicinal products protect their products from deliberate contamination. Originally developed by the U.S. military, the technique can also be applied to raw/starting materials, production, distribution, and commercial and retail sales.

mark durivage

Mark Durivage

Mark Allen Durivage is the managing principal consultant at Quality Systems Compliance LLC and an author of several quality-related books. He earned a BAS in computer aided machining from Siena Heights University and an MS in quality management from Eastern Michigan University. Durivage is an ASQ Fellow and holds several ASQ certifications, including CQM/OE, CRE, CQE, CQA, CHA, CBA, CPGP, CSQP, and CSSBB. He also is a Certified Tissue Bank Specialist (CTBS) and holds a Global Regulatory Affairs Certification (RAC). Durivage resides in Lambertville, Michigan. Please feel free to email him at mark.durivage@qscompliance.com with any questions or comments, and connect with him on LinkedIn.