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Featured Articles

July 2010


Karl Vahey

Failure Investigation: Treating the Root Cause, Not Symptoms

Karl Vahey
Director of Compliance, International RA/QA, Covidien

Why should medical device manufacturers perform failure investigations? One reason is that performing failure investigations is a regulatory requirement; the Code of Federal Regulations (21 CFR 820) in areas such as Non-Conforming Product, Corrective and Preventive Action and Complaint Files describes the failure investigation requirements. Conducting failure investigations is also simply good business practice and can lead to reduction in scrap and rework, process improvements and the elimination of recurring issues. However, the most significant reason is that they allow customers (i.e, the patients) to expect safe, reliable and effective products that perform as intended.

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John Lincoln

The Medical Device Design History File, Technical File / Design

John Lincoln
Principal Consultant, J.E. Lincoln and Associates

The United States Food and Drug Administration recognizes that with devices, the majority of serious problems are introduced during the design/change phases of development for either new or changed products. Changes to existing products are addressed under Change Control, Engineering Change Orders, and similarly required cGMP procedures. In the mid 1990s, it was recognized that the design of new product or major changes/line extensions to existing products was not well controlled. Recognizing this issue led to a solution: Design Control.

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Brian Curran

Automating Training Control Processes for Compliance

Brian Curran
SVP, Strategic Marketing & Product Management, MasterControl, Inc.

FDA regulatory requirements and ISO quality standards mandate companies to execute and document employee training. (21 CFR 211.25 and 820.25) These requirements ensure employees understand how to perform their duties within company and industry guidelines. Well-managed training programs minimize the risk of non-compliance and improve product quality. This paper identifies the basis for the requirements and examines the associated challenges for meeting those requirements, and in addition, the shortcomings that lead to general system failures. A new approach for meeting and going beyond the tracking of requirements is presented.

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Did you know that those medical device companies that operate in countries that are members of the GHTF (Global Harmonization Task Force) and that have successfully completed an ISO 13485:2003 based audit may be allowed to submit the ISO audit results in place of the inspection that would otherwise be required by the FDA.
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