GxP Lifeline

 

  • When Is A CRO Not A CRO? (And why does that make enforcement hard?)

    11 February, 2016 amie Colgin, Colgin Consulting

    Investigator site personnel recorded observations about clinical trial subjects in paper medical charts. Lab work was performed and interpreted at a local lab; X-rays and ECGs were taken and interpreted locally; and results were sent back to the investigator.

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  • FDA Issues Draft Cybersecurity Guidance for Device Manufacturers

    9 February, 2016 Jason C. Gavejian, CIPP, Principal, Jackson Lewis P.C.

    Last week (January 22, 2016), the U.S. Food and Drug Administration (FDA) issued draft guidance outlining important steps medical device manufacturers should take to address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance, which details the agency’s recommendations for monitoring, identifying, and addressing cybersecurity vulnerabilities in medical devices after they have entered the market, is part of the FDA’s ongoing efforts to ensure the safety and effectiveness of medical devices in the face of potential cyber threats.

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  • CLIA vs QSR (What You Don’t Know Can Hurt You)

    4 February, 2016 Paula Gray, Navigant & Sharon Kvistad, Navigant

    Many industries including automotive manufacturers, NASA, information technology systems, and countless others suggest or even require implementation of a Quality Management System (QMS) in order to ensure products are manufactured to a high quality standard. For products like medical devices, QM systems ensure that products are not only of a high quality, or deemed “effective” to perform as they are intended, but are also safe for their intended use. For all laboratory testing, Congress passed the Clinical Laboratory Improvement Amendments (CLIA), in 1988, which established quality standards to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. The Centers for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services (CMS) published final CLIA Quality Systems laboratory regulations that became effective April 24, 2003.

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  • One Q & a Lotta A’s about SOPs for Research Sites

    2 February, 2016 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    “What are your thoughts about having SOPs for clinical research sites versus having working guidelines in lieu of SOPs?”

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  • People Don’t Fail, Processes Do

    28 January, 2016 Terry Smith, Lean Enterprise Institute

    Lean isn’t only a mindset. It gives you and your organization tons of tools and techniques you can apply immediately to improve your business processes. One of my favorites is the 5 Whys. It’s the best demonstration I think of how in fact, people don’t fail, processes do.

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  • The FDA Just Called! Are You Ready for an Inspection?

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

    If the U.S. Food and Drug Administration (FDA) called tomorrow to schedule a visit to your facility, would you go into panic mode or would you go on with your day, business as usual? For many, an FDA inspection can be a scary prospect. It can be extremely difficult, and failing it can have significant consequences. With proper preparation, however, the FDA’s call to schedule an inspection doesn’t have to be a nightmare scenario.

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  • How to Respond to FDA Inspection Observations, Including Those You Dispute

    26 January, 2016 Martin Browning, President, EduQuest, Inc.: FDA expert investigator and rule-maker for 22 years

    Although FDA is strapped with limited resources and competing priorities, the Agency continues to hammer regulated companies with FDA 483 inspection observations and Warning Letters.

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  • New Developments in IEC 60601 Amendment 1 & Risk Management: Part 2

    21 January, 2016 Mark Leimbeck, Program Manager UL EduNeering

    When the 3rd Edition of IEC 60601 was published, two significant changes from the 2nd Edition were introduced: first, an expansion in the scope of the Standard from basic safety (only) to include essential performance; and second, introduction of a requirement for assessment of the risk management process applied by manufacturers in developing their medical devices.

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  • New Developments in IEC 60601 Amendment 1 & Risk Management: Part I

    19 January, 2016 Mark Leimbeck, Program Manager, UL EduNeering

    When the 3rd Edition of IEC 60601 was published, two significant changes from the 2nd Edition were introduced: first, an expansion in the scope of the Standard from Basic Safety (only) to include Essential Performance; and second, introduction of a requirement for assessment of the Risk Management process applied by manufacturers in developing their medical devices.

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  • Do You Really Want to Be An Executive In An FDA-Regulated Company?

    14 January, 2016 James R. Phelps, Hyman Phelps & McNamara, P.C

    Last Thursday, at the 16th Pharmaceutical Compliance Congress and Best Practices Forum, Principal Deputy Assistant Attorney General for the Justice Department’s Civil Division, Benjamin Mizer, reviewed enforcement policies that the Department of Justice will follow. Appropriate to the forum, he focused on the industries regulated by FDA. The emphasis he gave to the requirements for settling civil and criminal cases brought against organizations gives sharp focus to the problem of doing business when governed by a law that operates with a malum prohibitum standard of liability, a law that permits findings of criminal guilt without proof of intent or guilty knowledge.

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  • 6 Ways Quality Managers Can Build a Culture of Quality

    12 January, 2016 Beth Pedersen, Marketing Communications Specialist, MasterControl

    If you’re a quality manager, you have a demanding job. In a nutshell, you’re responsible for ensuring satisfactory and consistent quality throughout every successive step of the development of your products and services, a duty which requires you to wield a massive skill set and wear many different hats. Your daily existence revolves around quality; you dissect it and measure it and evaluate it and analyze it; you sleep, eat and breathe quality. And yet, how often do you really contemplate the concept of quality, and what it means to your company beyond the daily rigors of meeting customer requirements and upholding mandatory regulations and standards?

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  • 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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