GxP Lifeline

 

  • How to Ensure You are Following the ISO 9001 Certification Process

    7 January, 2016 Stuart Patch, Content Writer, Compass Assurance Services

    How to Ensure You are Following the ISO 9001 Certification Process

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  • 8 New Year’s Resolutions for Quality Professionals

    5 January, 2016 David R. Butcher, Marketing Communications, MasterControl

    ‘Tis the season to set New Year’s resolutions. With 2015 behind us and a whole new year ahead, now is a great time to reflect on what we’ve accomplished over the past year, as well as on areas in which we might improve. New Year’s resolutions offer a great opportunity for those who have put off making the changes they aspire to make.

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  • Big Changes for ICH GCP & EU Regulations

    31 December, 2015 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

    The most substantial change to international guidelines in 20 years occurred earlier this year when the ICH* issued a draft addendum to its GCP guidelines, ICH E6(R2).

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  • 5 Lessons I Learned from a Successful ISO 9001:2015 Certification Audit

    29 December, 2015 Lillian Erickson, Global Quality Manager, MasterControl Inc.

    The publication of ISO 9001:2015 in September generated much anxiety among companies fearing a bumpy transition to the new and significantly changed international standard. Admittedly, we at MasterControl were not immune to those worries.

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  • A Season for Giving That Lasts All Year

    23 December, 2015 Beth Pedersen, Marketing Communications Specialist, MasterControl

    We all feel it this time of year. As temperatures drop and snowflakes swirl, lights and festive decorations illuminate the long, dark nights, and names are diligently checked off seemingly endless shopping lists, we know that the holiday season is upon us. In spite of the stress that can accompany the holidays – the long lines, the gift wrapping, the social obligations – this time of year marks a widespread urge to give: to family, to friends, even to those we’ve never even met. We all feel it, this intangible, albeit very real, spirit of giving.

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  • Using Quality by Design to Improve Manufacturing

    22 December, 2015 Ronald D. Snee, PhD Snee Associates, LLC

    Much of the literature on quality by design (QbD) has focused on the creation of the “Design Space” (ICH 2009) which is the combination of levels of the critical process parameters that produces in-specification product. Design space creation is critical but a process control strategy is also essential and is an integral part of QbD. Stage 3 of the FDA Process Validation Guidance calls for “Continued Process Verification” (CPV), or continually verifying the process is doing what it is supposed to do throughout the life of the product (FDA 2011, Snee 2015). Also if we are to be effective in using life cycle management to manage the process over time. we must have a process management system in place that integrates both process control and process improvement (Snee and Gardner 2008, Snee 2010b).

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  • Preparing for ISO 13485:2016 Changes

    17 December, 2015 James Jardine, Marketing Communications, MasterControl

    As 2015 comes to a close, medical device manufacturers throughout the world share one collective concern: how will the ISO 13485:2016 revision compare with other versions of the standard? In a new three-part video series, Walt Murray, MasterControl’s director of Quality and Compliance Consulting (QCC) services, walks through what, why, when and how changes are coming to the standard.

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  • 6 Lessons that Quality Managers Can Learn from ‘Star Wars’

    15 December, 2015 David R. Butcher, Marketing Communications, MasterControl

    Beginning with A New Hope nearly 40 years ago, characters in the epic Star Wars saga have offered many lessons that may prove valuable for even the most seasoned quality managers. There are numerous examples of positive behaviors that managers might consider emulating in their daily work and behaviors that should always be avoided.

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  • The Drug Supply Chain Security Act: Current Impact

    9 December, 2015 David Dills, Sr. Consultant, Regulatory & Compliance, Devices NovusLife

    On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 (DQSA) into law, bringing a successful conclusion to efforts by the industry and consumer groups to create a national pharmaceutical serialization and track and trace regulation, one that eliminated the patchwork of state laws in addition to providing new regulations for compounding pharmacies. This is the most complex pharma track and trace law ever passed.

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  • How Performance Excellence Helps Broaden the Horizons of Quality

    7 December, 2015 Mickey Garcia, Segment Manager, Medical Devices, MasterControl

    Since W. Edwards Deming’s pioneering work in the 1950s, we have witnessed remarkable progress in the disciplines of both quality and management. Through the years, the best practices of the day have been given fancy names such as total quality management (TQM), Six Sigma and, most recently, Lean everything—just to name a few. With so many hifalutin terms being bandied about, it would be easy to dismiss an emerging term like performance excellence as just another buzzword. But there’s a case to be made for incorporating it more fully into our quality-related vocabulary: to help us, as Dr. Mikel Harry says, look beyond the mere business of quality and focus increasingly on the quality of business.

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  • The Mysterious "No Fault Found"

    3 December, 2015 Harish Jose Senior Quality Assurance Engineer

    As a quality engineer working in the medical device field, I find there is nothing more frustrating than a “no-fault-found” condition on a product complaint. The product is returned by the customer due to a problem while in use, and the manufacturer cannot replicate the problem. This is commonly referred to as no-fault-found (NFF). I could not find a definite rate on NFF for medical devices. However, I did find that for the avionics industry it is 40 percent to 60 percent of all the complaints.

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  • Inspection Readiness: Leveraging Inspection Focus Areas and Increasing the Transparency of Investigator Oversight

    1 December, 2015 Jessica Masarek, Quality Assurance Consultant | Independent Auditor Director, Muse Clinical

    Audits and inspections seem to be wrapped in a shroud of mystery, making folks stressed and unsure of exactly what is going to happen. What if I say the wrong thing? What if I don’t know the answer? What if I can’t provide what they are asking for? Realistically, all of these things will probably happen! That said, as long as you are honest, all will be well. Mistakes happen and no auditor or inspector is expecting perfection. We are expecting transparency. As an auditor, my goal is to confirm that the trial is run in a way that ensures the safety of subjects, protects their rights, and generates reliable data. Sponsors want to continue working with sites in which so much effort has been invested and will work to identify areas for improvement if deficiencies are noted. An inspector has a similar goal with respect to the assessment of trial conduct. So, how do we ensure that trials are run at the level of quality that regulators are looking for and that are truly inspection ready?

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  • How ISO 9001: 2015 May Preview Upcoming ISO 13485 Changes

    25 November, 2015 David R. Butcher, Marketing Communications, MasterControl

    This fall, the International Organization for Standardization (ISO) published ISO 9001:2015, the updated quality management system (QMS) standard that now follows a new, higher-level structure and includes a number of other key changes that regulated companies have three years to meet.

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  • Holistic CQMS: The Modern Model of Clinical Trial Management

    23 November, 2015 James Jardine, Marketing Communications, MasterControl Inc.

    The life science industry is experiencing a transformation in the clinical trial management paradigm. The timeworn clinical trial management system (CTMS) archetype is being increasingly supplanted by a more comprehensive and efficient clinical quality management system (CQMS) model.

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  • 9 Crazy Cousins You Probably Shouldn’t Invite to This Year’s Thanksgiving Dinner and 9 Reasons You Could Invite SCORM (Compliance) Instead

    19 November, 2015 Marci Crane, Localization Manager, MasterControl

    Thanksgiving in the USA is a wonderful time of year when we are reminded of everything that we have and how lucky we are to have it. We express our gratitude for what we have, where we live and those we love.

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  • The Future of Medical Device Registries

    17 November, 2015 David R. Dills, Sr. Consultant, Regulatory & Compliance, Devices: NovusLife

    A registry is broadly defined as a collection of information about individuals, usually focused around a specific diagnosis, condition, or intervention. Individuals may provide information about themselves to a registry on a voluntary basis, either directly or through their physicians. A registry can be sponsored by a government agency, nonprofit organization, health care facility, or private company, and over time can provide researchers and other health care delivery stakeholders with first-hand information about patients, both individually and as a group, which can increase our understanding of that condition. This post places key emphasis on medical device registries and why this topic is becoming increasingly important with FDA and our device manufacturers.

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  • eTMF Management: Don’t Settle for a One-Trick Pony!

    12 November, 2015 Patricia Santos-Serrao, MasterControl's Market Segment Manager, Global Pharmaceutical, Blood & Biologics

    Organizations searching for an electronic trial master file (eTMF) solution are likely to stumble upon various vendors claiming to be the “industry leader in eTMF” or some variation of this statement. With so many vendors claiming to be leaders, what does that mean to be a leader in eTMF? Should it factor into my decision as I evaluate and choose a solution for my organization? The answers to that question may not be a clear cut as one may think.

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  • 6 Military Skills Highly Valuable to Manufacturers

    11 November, 2015 David R. Butcher, Marketing Communications, MasterControl

    Following years of high unemployment, the hiring outlook for service members transitioning into the civilian labor force is improving. The unemployment rate for veterans from all branches of the military is now just 3.9 percent, compared with 4.5 percent a year ago and a current national unemployment rate for all Americans of 5 percent, according to the U.S. Bureau of Labor Statistics last week.

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  • Why Every Business Needs to Make ISO Certification a Priority in 2015/2016

    10 November, 2015 Stuart Patch, Content Writer, Compass Assurance Services; info@compassassurance.com.au

    There are many benefits for organisations gaining certification and for those organisations that are currently certified, ensuring those benefits continue to be realised is very important. Below I look at the benefits of certification and also what are the benefits of keeping abreast of upcoming changes in standards.

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  • Training Effectiveness – A Quality by Design Approach

    5 November, 2015 Holly DeIaco-Smith, MS, HDS Consulting

    In the role of a consultant, you have the benefit of seeing what works well across your client base and their shared common pain points. Because of this perspective, I’m often invited onto a project to provide guidance on best practices and practical advice on how to avoid the common pain points.

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