Phonize Inc., ComplianceOnline and MetricStream Host FDA Speakers to Help Managers in Life Sciences Companies Know What They Must Do to Leverage the New Quality Guidance
Register here to attend the full two day event designed exclusively for governance, risk and compliance training for companies in the Life Sciences.
San Francisco, Calif. September 15, 2015 – A few weeks ago, the U.S. Food and Drug Administration (FDA) took an important step in advancing the quality of medications with the release of draft guidance for the pharmaceutical and Medical Devices industries called, “Request for Quality Metrics.” In two days, at the Medical Device Summit 2015 hosted by Phonize Inc., ComplianceOnline and MetricStream, eight FDA experts will discuss what managers at pharmaceutical and medical device companies need to know to leverage the new metrics. Register here for more information about the event.
The FDA experts will focus on what managers need to know to leverage the new guidelines. They will discuss how the FDA will evaluate the quality of the facilities and the processes that manufacturers use to make FDA-regulated drugs, biologics and Medical Devices. Manufacturers and suppliers will also get an overview of how to conduct their own robust quality measurements on their own products.
PHONIZE chief compliance officer and co-chair of Medical Device Summit 2015 Angela Bazigos stated it’s critically important for patients, health care professionals, caregivers, payers, and others to have confidence in how medications and Medical Devices are made. “Quality metrics,” she added, “or the measures used to assess the quality of drug biologic and medical device manufacturing, can help the FDA achieve their goal of strengthening their efforts to ensure that FDA-regulated products are not only demonstrated to be safe and effective, but also continually manufactured under strict quality standards. We’re delighted to team with MetricStream, the market leader in governance, risk and compliance solutions and ComplianceOnline, the largest GRC advisory network, to present this extraordinary panel of FDA experts.”
According to Bazigos, the FDA believes a careful analysis of quality metrics can help its agency better identify which facilities are at the highest risk for quality problems. “Quality is also directly connected to a consistent supply of needed medications and medical devices,” added Bazigos. “Over the years, disruptions in supply occurred due to manufacturing production flaws. The FDA believes that a company’s own robust quality measurement system, along with their quality measurements, can help manufacturers better identify factors that may predict manufacturing problems – and move us a step closer toward reducing and controlling these disruptions—which can help improve the quality of life for patients if not save lives.
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MetricStream is the market leader in enterprise-wide Governance, Risk, Compliance (GRC) and Quality Management Solutions. MetricStream solutions are used by leading global corporations in diverse industries such as Financial Services, Healthcare, Life Sciences, Energy and Utilities, Food, Retail, CPG, Government, Hi-Tech and Manufacturing to manage their risk management programs, quality management processes, regulatory and industry-mandated compliance and other corporate governance initiatives. MetricStream’s customers include UBS, Société Générale, Pﬁzer, Philips, Cummins, Kellogg’s, Mondelez International, SanDisk, and NetApp.
MetricStream also owns and operates the www.ComplianceOnline.com portal – the largest GRC advisory network and one of the largest GRC communities. MetricStream is headquartered in Palo Alto, California, USA (www.metricstream.com).
About Phonize, Inc. USA
PHONIZE is morfing the way companies can deliver sales, customers service and compliance training content, anytime, anywhere with Morf Playbook™, a fast, fun and easy training delivery platform. For the first time, Morf Playbook offers the power and the simplicity to author and deliver one-to-one training to millions, anytime, anywhere. With EYEQ gamified three minute mini courses and virtual Coach,™ a validation engine and an analytics dashboard–EYEQ is a complete system for managers and professionals to level up training on a smartphone or tablet and perform at their best while managing governance and compliance on a sustained basis. Founded in 2013, PHONIZE USA and Morf Labs are based in San Francisco. For more information, please visit www.phonize.com.
Vice President Marketing of Phonize, Inc. USA