FALLS CHURCH, Va., Jan. 15, 2019 /PRNewswire-PRWeb/ -- Early bird pricing for Medical Device Risk Management: Prepare
Risk management is just plain hard, complicated, conflicted, confusing. And it is getting even more complicated
The international standard is under revision. While the changes in the process are not intended as "major", the new standard adds new definitions, changes the clause numbering, introduces new requirements, changes many of the annexes, and moves them to a new document.
In a sister storm, the EU is in transition to new regulations. There are new concepts, new risk reduction requirements, and new applications. Two areas of impact are side-effects (residual risk) and benefit-risk analysis as a life-cycle requirement.
Risk management procedures will require a major overhaul.
FDAnews and Ombu Enterprises are here to help devicemakers prepare for the winds of change, with a two-day workshop designed to untangle every mystery of risk management and a path to full compliance. During the workshop attendees will:
The risk management guide is Dan O'Leary, a favorite presenter at dozens of FDAnews-sponsored workshops. Dan provides the understanding and practical tools to join the disparate pieces into a coherent whole and create a solid foundation for the coming changes. Dan boasts more than 30 years' experience in quality, operations and program management in regulated industries including aviation, defense, medical devices and clinical labs.
Risk management affects nearly every aspect of medical device manufacture. Yet many devicemakers lag behind the curve, courting warning letters or worse. Get up to speed quickly and easily.
Early bird pricing ends on Tuesday, Jan. 22.
Who Should Attend:
Here are just a few of the many executives who will benefit:
Webinar Details: Medical Device Risk Management Prepare for the Winds of Change **An interactive workshop from FDAnews and Ombu Enterprises** Feb. 19-20, 2019 Atlanta, GA https://www.fdanews.com/mdriskmanagement
Tuition: Early Bird Pricing: $1,597 (available until Jan. 22, 2019) Regular Pricing: $1,797 (after Jan. 22, 2019) Significant team discounts are available.
Easy Ways to Register: Online: https://www.fdanews.com/mdriskmanagement By phone: 888-838-5578 or 703-538-7600
About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
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