• Writing and Enforcing Your SOPs for GxP Compliance Success - for Quality Professionals

    14 July, 2011 David R. Dills, Quality & Compliance Advisor

    This paper addresses the fundamentals of writing and enforcing your SOPs not only for compliance and in accordance with internal company policies and requirements but certainly for ensuring compliance with FDA requirements as well.

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  • Preparing for a Safety Inspection

    12 July, 2011 Steve Jolley, Subject Matter Expert, Global Safety Compliance and Signal Detection

    This article will be published in the September 2011 issue of the Drug Information Journal. Copyright © 2011, Drug Information Association.

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  • Implementation of the Food Safety Modernization Act

    12 July, 2011 Cathy Crawford, HACCP and Food Safety Expert

    As of July 3rd, the Food and Drug Administration (FDA) will have increased authority to use administrative detention as an enforcement tool. For this reason, companies that manufacture, prepare, pack or hold food should ensure strong record keeping practices.

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  • Do you know how to navigate the FDA's website

    12 July, 2011 MasterControl

    by Carl Anderson, Regulatory Affairs and Quality Assurance Consultant

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  • Certification and Advanced Degrees: Are They Worth It?

    12 July, 2011 John A. Challenger, CEO, Challenger, Gray & Christmas, Inc.

    Note: A long-running discussion in the LinkedIn ASQ Group about the significance of certification led us to ask this employment expert about the value readers receive from advanced degrees and certifications, particularly in a highly-competitive job market like life sciences.

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  • FREE training from FDA CDRH Learn

    10 July, 2011 MasterControl

    For the medical device industry, it's not always easy to understand and correctly implement FDA regulations. CDRH (Center for Devices and Radiological Health) is providing a free online educational tool with training modules that describe "many aspects of medical device and radiological health regulation [that cover] both premarket and postmarket issues."1

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  • How to Build a Business Case for a Quality Management System

    14 June, 2011 Jon Nugent, Managing Director of Client Services, Business Intelligence Solutions

    It is impossible for FDA-regulated manufacturers to conduct business without paying close attention to regulatory compliance.

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  • Hamburg Speaks about Innovation at FDLI Annual Conference

    14 June, 2011 Abby Foster, Managing Editor, FDLI

    "For FDA, innovation is not just about new ideas, but it is about making sure that those new ideas truly translate into the products and opportunities that people need and count on," Commissioner of Food and Drugs, Margaret Hamburg, explained in her opening address at FDLI's 54th Annual Conference.

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  • Product Risk Management Under ISO 14971:2007 and ICH Q9

    14 June, 2011 John E. Lincoln, J.E. Lincoln and Associates LLC

    Risk management has many connotations depending upon the audience. Its definition depends upon whether the context is company disaster recovery, company/product liability, protection of intellectual property, protection of the data processing system and data, and similar. This article covers medical device and pharmaceutical hazard analysis and risk management.

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  • The Use of "Poka Yoke" with Medical Device Design and Manufacturing

    17 May, 2011 by Jim Shore, Product and Process Improvement Leader, Dynisco

    The Poka Yoke method is something that improves your daily life; why not use it to make your product better, as well? The best solutions are simple, quick to implement and 100 times more effective than a 100-percent final inspection.

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  • FDA Considering 'Super Office' of Drug Safety

    17 May, 2011 MasterControl

    This article has been reprinted with permission from RPM Report.

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  • FDA Taking Comments Regarding PGx Guidance Document

    12 April, 2011 MasterControl

    This article was originally published by EduQuest in the March 2011 issue of EduQuest-ions & Answers.

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  • Quality Inspiration: Six Quality Quotes for You to Consider

    5 April, 2011 Jennifer Stepniowski, Special Project Manager, Pro QC International

    I enjoy insightful prose...I enjoy reading it, thinking about it and sharing it with others. I think memorialized words of wisdom from others not only define the originator, but they also contribute to our individualism.

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  • FDA Finalizes Regulation Regarding Software for Medical Devices

    22 March, 2011 MasterControl

    The path to market for software that is to be used with medical devices can be rigorous. The FDA recently announced (Feb. 14, 2011) a "less burdensome path to market" according to FDA News.1 These systems (i.e, software and hardware combined) are known as Medical Device Data Systems (MDDS) and have been recently defined as low-risk devices or "Class I" devices, which definition relieves medical device professionals of the immense effort required during premarket review. However the MDDS systems

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  • FDA Announces 510(k) Changes

    22 March, 2011 MassDevice staff

    MassDevice.com is the online busines journal of the medical device industry. Visit www.massdevice.com for the latest FDA and medical device business news.

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  • Why Baldrige Works

    15 February, 2011 Rose Almon-Martin, V.P. Performance Excellence, MEDRAD, Warrendale, Pa.

    There's no doubt that the Baldrige Criteria drive excellent performance. Of course, the perennial question for any improvement approach is "What's the return on my investment?" Cargill, a $107 billion company that produces and markets food, agricultural, financial and industrial products and services, says Baldrige is a huge return on investment. Their divisions that use the Criteria achieve 130 percent of their earnings targets versus divisions not using the Criteria, who achieve about 82 perce

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  • End-to-End Supply Chain Visibility: It's no VUCA-tion for Supply Chain Professionals

    31 January, 2011 Stephen F. DeAngelis, Technology and Supply Chain Sector Entrepreneur, Enterra Solutions, LLC

    This article was originally published in the Enterra Insights Blog, which is sponsored by Enterra Solutions, LLC.

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  • For Life Science Professionals - Is Your Executive Management Involved with Quality?

    31 January, 2011 Christine Park, Christine Park & Associates

    Note: Though this article references 21 CFR Part 820, it is applicable to any company that is striving for more quality-system input and involvement from management.

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  • Minimizing the Risk of Donor Disease Transmission

    4 January, 2011 Emily Blumberg, Professor of Medicine and Program Director for the Infectious Diseases Fellowship Training Program, University of Pennsylvania

    Each year in the United States, nearly 30,000 people receive the opportunity to save, extend or enhance their lives through the human gift of organ donation. Of those, roughly three-fourths of the organs transplanted come from deceased donors.

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  • Supply Chain Oversight is the FDA's Next Area of Concern

    4 January, 2011 Alan Schwartz, Consultant, mdi Consultants, Inc., and Former Supervisor of Field Operations, USA FDA

    The FDA recently stated its intent to stretch its enforcement reach over foreign device suppliers through consent decrees. The FDA also asked manufacturers and importers to take bigger steps toward managing suppliers and tightening up the supply chain. Carmelo Rosa, an FDA compliance officer, explains that "Currently, the agency only has authority to establish import alerts for foreign companies with good manufacturing practice violations but it is looking at other options."

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