• The Effect of Quality Management on Compliance with European Union GMP Standards

    14 April, 2017 James Jardine

    How crucial is Europe to the global pharmaceutical market? First consider that Europe, North America, and Japan comprise 80 percent of the world's pharmaceutical market. Take that statistic in conjunction with the estimation from Report Buyer, a renowned market research firm, that the Western European market alone is expected to grow to $245.3 billion by 2012.

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  • 21 CFR Part 11 and Predicate Rules of FDA, What to Know

    14 April, 2017 David Ade, Product Manager, MasterControl

    Ten years after the FDA issued 21 CFR Part 11, the agency is expected to issue a new guidance for compliance, even as it considers revising the regulation.

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  • GCP Compliance Strategies for 2009 - Medical Device Industry

    18 April, 2017 Carl Anderson, Regulatory Affairs and Quality Assurance Consultant, Field of FDA Health Product Approvals including Medical Devices, Drugs and Biologics

    The FDA press release dated April 30, 2008 should have caught the eye of every regulatory affairs and quality assurance professional responsible for compliance to the FDA. "FDA Embarks on Major Hiring Initiative for its Public Health Mission" the press release blared. "Agency will fill more than 1,300 positions within the next several months," it continued. That is more than triple the number of positions the agency filled in fiscal years 2005-20071.

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  • Assessing the Proposed Changes to the US FDA's 510(k) Programme

    6 November, 2010 Karen M. Becker, PhD, Founder and Chief Executive Officer of Becker & Associates Consulting, Inc.

    Note: This article originally appeared in the September-October issue of Regulatory Affairs Medtech, and was published online at www.regulatoryaffairsmedtech.com on September 8, 2010.

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  • Beyond the Basics - Building Business Value through an Effective Compliance Program

    18 April, 2017 Peter Claude, Pharmaceuticals and Life Sciences Partner, and Jean Sands, Pharmaceuticals and Life Sciences Manager, PricewaterhouseCoopers LLP

    Through the recent overhaul of the AdvaMed Code of Ethics, medical device companies gained the opportunity to use the renewed emphasis on ethics to revamp their approach to compliance. Most companies quickly integrated the updated Code provisions into their compliance policies and trained their employees to follow explicit guidelines about appropriate and inappropriate interactions and arrangements with healthcare professionals. Now they stand ready to take the next steps to build global complia

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  • CAPA: Key Stumbling Block for Device Firms

    17 April, 2017 MasterControl

    GE OEC Medical Systems recently signed a consent decree with the FDA because of CGMP deficiencies, including failure to establish and maintain adequate corrective and preventive action procedures. The news that a company this size has a broken CAPA system is shocking. But at the same time, it is not altogether unexpected if you consider inspection trends for this industry.

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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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  • FDA Chooses MasterControl's QMS Article

    MasterControl

    MasterControl, a global provider of quality management systems (QMS), is pleased to announce that it has been selected as the QMS software provider for the U.S. Food and Drug Administration (FDA). More specifically, the Office of Regulatory Affairs (ORA) within the FDA has contracted with MasterControl through its partner, i4DM.

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  • 21 CFR Part 11: What's New? GxP Lifeline

    14 April, 2017 MasterControl

    The anticipation over a new 21 CFR Part 11 and a new companion guidance for compliance is waning because of persistent speculation within the industry that the FDA is not ready to release the documents until later this year or perhaps next year.Ever since the agency issued a nonbinding guidance on Part 11's scope and application in 2003, the industry was rife with talk about the need for a better guidance, and perhaps a new and better regulation altogether. Four years later, there is neither a n

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  • Adopting Technology In The Life Science Industry Article

    14 April, 2017 Curt Porritt

    By Curt Porritt

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  • How to Solve the Top Five Complaint-Handling Challenges

    14 April, 2017 MasterControl

    Consumer complaints are at the heart of every product recall. Whether it's Merck's voluntary recall of the pain medication, Vioxx, or the Class I recall of counterfeit LifeScan blood glucose test strips, chances are both actions stemmed from complaints.The reporting of side effects or adverse events is incorporated in FDA regulations. The agency operates MedWatch, a safety information and adverse-event reporting program that allows health-care professionals and the public to report serious probl

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  • Shook Up Without QA: A Brief Look At The 24th Annual SQA Meeting

    14 April, 2017 MasterControl

    Another well-attended and enlightening annual meeting of the Society of Quality Assurance (SQA) was held on April 20-25, 2008 in Memphis, Tennessee. In keeping up with the theme of "All Shook Up Without QA," the meeting offered the state-of-the-art experience in promoting and advancing the principles and knowledge of quality assurance essential to regulated research in the human, animal and environmental health sciences. For those that have never attended an SQA annual meeting, this year's meeti

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  • How to Solve the Top Five Batch Record Challenges

    14 April, 2017 Oliver Wolf

    By Oliver Wolf

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  • Solutions for Most Common Change Control Issues Face by Life Science Companies

    14 April, 2017 MasterControl

    1. Inefficient System of Communication. You need effective communication to be able to implement change properly. For a company that relies on a paper-based or partially electronic system, this is the typical scenario: Once or twice a week, up to 15 people who constitute the Change Control Board meet for two hours each time to discuss engineering and other document changes. Before and after each meeting, documents are routed using the inter-office mail system or via e-mail. The problem wi

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  • Five Things to Expect from a Compliance Software Vendor - GxP Lifeline

    14 April, 2017 Jim Murrin

    The advent of JetBlue's Customer Bill of Rights has increased public awareness about the consumer's fundamental right to get his or her money's worth. Whether you're buying an airline ticket or a car, you should know what you can expect from the seller.Let's apply this concept to life science companies purchasing software for managing the content derived from their GxP processes. In the February issue of this newsletter, we discussed the things that a life science end user should consider, namel

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  • Introduction to the eCTD - GxP Lifeline

    14 April, 2017 MasterControl

    The CTD (Common Technical Document) was proposed by the ICH working committee (the International Conference on Harmonisation) back in the early 1990s and finally agreed upon in November 2000. Its purpose was to provide life sciences companies with a common structure for registering drugs for human use to the regulatory agencies. The FDA was the first agency to adopt the CTD as a common structure for receiving product registrations from companies. Although the CTD submissions were initially deliv

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  • Quality Basics Simplify Complex Engineering Document Management Challenge

    6 October, 2010 Ted Shaar, Freelance Writer on Quality Topics

    This article was originally published in ASQ.

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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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