FALLS CHURCH, Va., Oct. 2, 2018 /PRNewswire-PRWeb/ -- Medical Device Complaint Management: Follow the Outcomes for Regulatory
Medical Device Complaint Management starts in one week.
Device and diagnostics makers face a jumble of QMS regulations in the U.S., Canada and the EU. They're maddeningly complex and can even conflict with each other and violations often trigger warning letters and other sanctions.
The stakes are high. It's worth two full days of to get things straight.
FDAnews has called on a top-rated presenter, Dan O'Leary of OMBU Enterprises LLC. Using actual warning letters, case studies, hands-on exercises and real-world examples, this interactive two-day workshop will arm attendees for every complaint management challenge that key regulatory agencies come up with, and helps integrate a complaint management program into QMS.
Plan on coming home with a deep understanding of:
Attendees will be working from course materials that include slides from PowerPoint presentations, copies of relevant guidances and regulations, and worksheets from 9 interactive exercises that Mr. O'Leary has prepared especially for this workshop.
QMS changes constantly. Take new requirements from the EU-MDR, with particular emphasis on post-market surveillance. It's one of the most complicated parts of a regulation rife with interlocking systems of plans and reports and just one example of the headaches involved in getting QMS right. But getting QMS right is job #1.
Reminder: Medical Device Complaint Management starts in one week.
Meet the Presenter: Dan O'Leary is President of Ombu Enterprises LLC, offering training and execution in Operational Excellence that focuses on analytic skills and a systems approach to operations management. Mr. O'Leary boasts 30+ years' experience in quality, operations, and program management in regulated industries including medical devices, clinical labs, aviation and defense. He is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
Who Will Benefit:
Conference Details Medical Device Complaint Management: Follow the Outcomes for Regulatory Compliance **Presented by FDAnews and Ombu Enterprises ** Oct. 9-10, 2018 – Waltham, MA http://www.fdanews.com/meddevicecomplaints
Tuition: Regular Registration: $1,797 Additional pricing options are available online.
Easy Ways to Register: Online: http://www.fdanews.com/meddevicecomplaints 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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