FALLS CHURCH, Va., Jan. 15, 2020 /PRNewswire-PRWeb/ -- Postmarket Solutions for Medical Devices An Interactive Workshop Presented by FDAnews and Ombu Enterprises Feb. 19-20, 2020 • Hilton Atlanta • Atlanta, GA
https://www.fdanews.com/postmarketproblemsmd
Early bird pricing for Postmarket Solutions for Medical Devices Workshop ends on Jan. 22.
Device and diagnostics makers face a jumble of postmarket 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 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 as well as help one integrate a complaint management program into device postmarket plans. During the workshop, attendees will:
Your Speaker: Your workshop leader is Dan O'Leary, President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years' experience in quality, operations and program management in regulated industries including aviation, defense, medical devices and clinical labs. He has a master's degree in mathematics; 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.
Conference Details: Postmarket Solutions for Medical Devices An Interactive Workshop Presented by FDAnews and Ombu Enterprises Feb. 19-20, 2020 • Hilton Atlanta • Atlanta, GA https://www.fdanews.com/postmarketproblemsmd
Tuition: Early Bird Pricing: $1,597 (available until Jan. 22, 2020) Regular Pricing: $1,797 (after Jan. 22, 2020) Significant team discounts are available.
Easy Ways to Register: Online: https://www.fdanews.com/postmarketproblemsmd 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
Advertisement
Early bird pricing for Postmarket Solutions for Medical Devices Workshop ends on Jan. 22.
Device and diagnostics makers face a jumble of postmarket 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.
Advertisement
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 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 as well as help one integrate a complaint management program into device postmarket plans. During the workshop, attendees will:
- Master preliminary analysis of complaint implications by reviewing example complaints to determine if subsequent processes, such as adverse event reporting, apply.
- Get a better sense of service record analysis to detect complaints by taking a closer look at examples of servicing activities to determine if the information includes a complaint.
- Identify complaint classification by examining examples of complaints and classify them using the multiple classification schemes from the regulatory systems.
- Analyze complaints to determine the need to update the risk management file in post-production data analysis.
- Become more familiar with adverse event reportability in various regulatory regions and determine the appropriate timelines.
- Interpret complaint examples to determine the need for corrective action and identify the required implementation steps and records.
- Compare and contrast complaint examples, determine the need for design changes, and identify required implementation steps and records.
- Determine field action by reviewing potential conditions for field actions arising from complaints and determine the reporting requirements and methods for each of the regulatory regions under consideration.
- Review design changes resulting from complaints and determine the need, method, and records for each of the regulatory regions under consideration.
Your Speaker: Your workshop leader is Dan O'Leary, President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years' experience in quality, operations and program management in regulated industries including aviation, defense, medical devices and clinical labs. He has a master's degree in mathematics; 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.
Conference Details: Postmarket Solutions for Medical Devices An Interactive Workshop Presented by FDAnews and Ombu Enterprises Feb. 19-20, 2020 • Hilton Atlanta • Atlanta, GA https://www.fdanews.com/postmarketproblemsmd
Tuition: Early Bird Pricing: $1,597 (available until Jan. 22, 2020) Regular Pricing: $1,797 (after Jan. 22, 2020) Significant team discounts are available.
Easy Ways to Register: Online: https://www.fdanews.com/postmarketproblemsmd 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
