• Process Validation for Medical Devices

    17 April, 2017 Dan O'Leary, President, Ombu Enterprises, LLC

    Process validation is an essential part of medical device manufacturing but doesn't always receive the attention it deserves (and requires). The regulations provide the requirements (FDA QSR 820.75 and ISO 13485 7.5.2), but often manufacturers don't completely understand them and don't fully implement them. The consequences can be audit findings from a Notified Body or Inspectional Observations on an FDA 483.

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  • Quality Audit: Most Common Pitfall for Medical Device Firms

    17 April, 2017 MasterControl

    The FDA requires medical device firms to conduct quality audits to help ensure product quality and safety, but many firms apparently don't comply. Lack of audit procedures or audit schedule are among the most common problems for these companies during inspections, according to an FDA medical device specialist.

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  • Quality Audit: Most Common Pitfall for Medical Device Firms

    17 April, 2017 MasterControl

    The FDA requires medical device firms to conduct quality audits to help ensure product quality and safety, but many firms apparently don't comply. Lack of audit procedures or audit schedule are among the most common problems for these companies during inspections, according to an FDA medical device specialist.

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  • Quality By Design, Total Product Life Cycle, and Seven Ways to Improve Design Controls for an FDA Inspection

    17 April, 2017 Lori Carr, Regulatory Consultant

    With the unsteady economy and the ever-changing regulatory world that we find ourselves in, strong design controls within the medical device and biotech industries are a necessity. When faced with a multi-million dollar recall, no medical device company wants to wish it had instituted more robust design controls. Therefore, having a solid design control system is a must in the world in which we live.

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  • The Cost of Quality: a Study on Life Sciences

    14 April, 2017 MasterControl

    The Cost of Quality: a Study on Life SciencesThe Cost of Quality: a Study on Life Sciences webinar presents findings from the published report, The Cost of Quality: a Study on Life Sciences, a benchmark study by the AberdeenGroup. The report compares the quality standards and tactics of life science companies from the pharmaceutical, biotechnology, blood/biologics and medical device industries with those of Best-in-Class manufacturers. According to the report, "Aberdeen surveyed 169 [&helli

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  • Study: High-Performing Manufacturers Enforce Enterprise-Wide Quality Procedures as Top Business Strategy

    14 April, 2017 MasterControl

    A recent survey of 176 manufacturers throughout the world shows that more than half of best-in-class companies enforce enterprise-wide quality procedures as a top business strategy.These high-performing manufacturers take a more disciplined approach toward enforcing quality procedures, and are farther along in closing the quality loop than poorer performing companies, according to a benchmark study by the Aberdeen Group, a leading research group for the technology-driven value chain.The s

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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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  • Essential Elements of Effective CAPA Systems - Death by CAPA

    14 April, 2017 Ken Peterson, PathWise Inc.

    The end result objective of a corrective and preventative action (CAPA) is, quite simply, a solution to the issue from which the CAPA was generated. If it is not driving toward a solution, a CAPA is a waste of time and resources. For organizations in regulatory environments, CAPA is an overarching umbrella—all control points flow through to the CAPA system.

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  • GxP Lifeline - Five Top Deviation Management Challenges

    14 April, 2017 MasterControl

    MasterControl Deviations Management Software helps ensure FDA compliance.

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  • How to Solve Top Five Document Management Challenges - GxP Lifeline

    14 April, 2017 MasterControl

    Document management is such a fundamental need in any FDA compliance effort, and it poses so many challenges, that we could easily discuss the ?top 20? or more problems that plague life science companies. But in the interest of space, here are the top five document control issues that most companies complain about and some tips on solving them.

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  • Establishing and Operating an Effective GMP Auditing Program

    14 April, 2017 Robert L. Dana

    By Robert L. Dana

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