Articles by Mark Durivage
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FDA Proposes Safer Technologies Program For Medical Devices
10/2/2019
This article examines the CDRH draft guidance Safer Technologies Program for Medical Devices (STeP) and what it means for medtech manufacturers.
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What Happens To ISO 13485 When Annex L Is Adopted?
9/16/2019
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.
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Is Your Personnel Hygiene Plan Up To Date?
8/27/2019
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.
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How To Prepare For An FDA Inspection
7/29/2019
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.
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What Should You Do After An FDA Inspection?
3/29/2019
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.
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MDSAP's Effect On The Internal Audit Process
7/5/2018
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.
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A Better Way To Document QMS Procedures & Work Instructions In Life Sciences Manufacturing
5/11/2018
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.
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How To Ensure QMS Continuity During Leadership Transition
4/2/2018
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.
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How To Build A Value-Added GMP Supplier Management Program
2/12/2018
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.
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Using Risk-Based Thinking To Manage Suppliers
6/16/2017
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.