FALLS CHURCH, Va., Feb. 13, 2019 /PRNewswire-PRWeb/ -- Early bird pricing for Medical Device Complaint Management: Escape the Labyrinth ends on Feb. 20
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 time 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 one for every complaint management challenge that key regulatory agencies come up with, and help one integrate a complaint management program into a comprehensive QMS.
Plan on coming home with a deep understanding of:
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 — or ought to be — Job #1.
Early bird pricing ends on Wednesday, Feb. 20.
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:
Tuition: Early Bird Pricing: $1,597 (available until Feb. 20, 2019) Regular Pricing: $1,797 (after Feb. 20, 2019) Significant team discounts are available.
Easy Ways to Register: Online: https://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.
SOURCE FDAnews
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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.
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The stakes are high. It's worth two full days of time 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 one for every complaint management challenge that key regulatory agencies come up with, and help one integrate a complaint management program into a comprehensive QMS.
Plan on coming home with a deep understanding of:
- The regulators: The FDA, Canada, the EU current state and the EU future state … how they're similar, how they differ
- The role of QSR, ISO 13485:2016, ISO 14971:2007, and national and regional variants
- The many definitions of complaints: And their implications
- Warning letters: What they teach
- Process flow and decision points for U.S., EU and Canadian regulators
- Adverse event reporting: Decisions and timelines
- Trend reporting to regulators: Understanding the systems
- Field actions and associated regulatory reports: How to spot the triggers
- Design changes that trigger the need for updated submissions
- QSIT and the MDSAP Audit Model: How regulators use them
- And MUCH more!
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 — or ought to be — Job #1.
Early bird pricing ends on Wednesday, Feb. 20.
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:
- Quality management
- Regulatory affairs
- Quality engineering
- Design engineering
- Design/development
- Complaint specialists
- Corrective-action specialists
- Recall coordinators
- Medical staff evaluating risk, safety, or effectiveness
- General/corporate counsel
Tuition: Early Bird Pricing: $1,597 (available until Feb. 20, 2019) Regular Pricing: $1,797 (after Feb. 20, 2019) Significant team discounts are available.
Easy Ways to Register: Online: https://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.
SOURCE FDAnews
