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FDAnews Announces Medical Device Complaint Management: Follow the Outcomes for Regulatory Compliance, Oct. 9-10, 2018, Waltham, MA
Date:7/30/2018

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

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:

  •     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 manufacturers
  •     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

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.

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

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:
Early Bird Registration (until Sept. 11, 2018): $1,597
Regular Registration (Sept. 11, 2018 on): $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.

Read the full story at https://www.prweb.com/releases/fdanews_announces_medical_device_complaint_management_follow_the_outcomes_for_regulatory_compliance_oct_9_10_2018_waltham_ma/prweb15661351.htm.


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