ARTICLES BY MARK DURIVAGE

  • FDA's Accreditation Scheme For Conformity Assessment (ASCA) Pilot Program Explained
    FDA's Accreditation Scheme For Conformity Assessment (ASCA) Pilot Program Explained

    The ASCA Pilot is intended to provide increased confidence in testing results from ASCA-accredited testing laboratories, as well as decrease the burden of individual premarket submissions when manufacturers rely on testing completed by ASCA-accredited testing laboratories.

  • FDA Updates Several 510(k) Guidance Documents
    FDA Updates Several 510(k) Guidance Documents

    The FDA recently issued four final guidance documents governing 510(k) regulatory submissions, covering the Special, Abbreviated and Traditional 510(k) pathways, as well as the Refuse to Accept Policy for 510(k)s.

  • FDA Proposes Safer Technologies Program For Medical Devices
    FDA Proposes Safer Technologies Program For Medical Devices

    This article examines the CDRH draft guidance Safer Technologies Program for Medical Devices (STeP) and what it means for medtech manufacturers.

  • What Happens To ISO 13485 When Annex L Is Adopted?
    What Happens To ISO 13485 When Annex L Is Adopted?

    Although the structure of ISO 13485 will expand from the current eight main clauses to ten, most of the QMS requirements should essentially remain the same.

  • Is Your Personnel Hygiene Plan Up To Date?
    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
    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.

  • What Should You Do After An FDA Inspection?
    What Should You Do After An FDA Inspection?

    The FDA inspected your firm, and one or more FDA Form 483 inspectional observations were noted by its team. This article provides guidance on how to minimize or avoid additional enforcement actions.

  • MDSAP's Effect On The Internal Audit Process
    MDSAP's Effect On The Internal Audit Process

    The Medical Device Single Audit Program (MDSAP) is recognized by officially approved Auditing Organizations (ISO Registrars) to conduct a single regulatory audit, of a medical device manufacturer, that satisfies relevant requirements of the regulatory authorities participating in the program.

  • A Better Way To Document QMS Procedures & Work Instructions In Life Sciences Manufacturing
    A Better Way To Document QMS Procedures & Work Instructions In Life Sciences Manufacturing

    This article presents the requirements regarding documentation of QMS procedures and work instructions and then introduces methods that can be used to effectively document compliant procedures.

  • How To Ensure QMS Continuity During Leadership Transition
    How To Ensure QMS Continuity During Leadership Transition

    Many organizations with very robust QMSs routinely find themselves in a state of disarray and facing compliance issues when key members of the quality leadership team leave the organization.

  • How To Build A Value-Added GMP Supplier Management Program
    How To Build A Value-Added GMP Supplier Management Program

    For a supplier management program to provide added value to an organization, the supplier evaluation should look beyond the requirements of a standard or regulation.

  • Using Risk-Based Thinking To Manage Suppliers
    Using Risk-Based Thinking To Manage Suppliers

    This article will first present the definitions and requirements regarding risk pertaining to the control of suppliers and then introduce some tools to incorporate and integrate risk management techniques within the QMS specifically applied to supplier management/purchasing controls.

  • An Introduction To qFMEA – A Tool For QMS Risk Management
    An Introduction To qFMEA – A Tool For QMS Risk Management

    The real issue in developing a QMS failure mode effects analysis (qFMEA) for the quality management system is how to develop the scales traditionally used to calculate the risk priority number.

  • Integrating Risk Management In The Quality Management System — A Primer
    Integrating Risk Management In The Quality Management System — A Primer

    This article will first present the definitions and requirements regarding risk and then introduce some tools that can be utilized to incorporate and integrate risk management techniques in and throughout the QMS.

  • How To Establish The Number Of Runs Required For Process Validation
    How To Establish The Number Of Runs Required For Process Validation

    FDA regulations, ISO standards, and GHTF guidance documents do not prescribe the number of runs required for process validation activities. Industry has typically used three batches during the process performance qualification phase to demonstrate that a process is capable of consistently delivering quality product, but the so-called "rule of three" is no longer appropriate for process validation activities.

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.