Articles by Mark Durivage
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An Introduction To Sampling Plans
10/21/2019
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.
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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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Military Tool For Vulnerability Assessment: The CARVER + Shock Technique
5/13/2019
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.
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Inside FDA's Proposed Program To Establish Voluntary Quality Standards
4/17/2019
The FDA’s CDER recently released draft guidance aimed at the development and recognition of voluntary consensus standards for pharmaceutical quality.
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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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Integrating Risk Management Into Your QMS — An Essential Toolkit
6/11/2018
Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. Risk-based thinking can and should be applied to the organization’s strategic and tactical planning processes.
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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.