When it comes to QMS and complaint management, device and diagnostics firms face a welter of confusing, sometimes conflicting regulations from the FDA, the EU and Canada. And you don’t dare let your guard down, at the risk of a warning letter … or worse.
FDAnews and OMBU Enterprises LLC have teamed up to help you untangle these vexing problems. It’s a roll-up-your-sleeves interactive workshop in the heart of Boston, conducted by top-rated presenter Dan O’Leary.
Over the course of two full days of learning and networking, jam-packed with case studies and exercises developed specially for this workshop, you’ll gain insight into how to keep the regulators happy from here to Brussels and beyond:
- 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 you
- 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
- Recognize when a design change triggers an updated regulatory submission
- QSIT and the MDSAP Audit Model: How regulators use them
- And MUCH more!
Get ready to roll up your sleeves. You’ll be working from course materials that include slides from PowerPoint presentations, copies of relevant guidances and regulations, and worksheets from 10 interactive exercises that Mr. O’Leary has prepared especially for this workshop.
The conference takes place in the heart of Boston, cradle of our democracy. You’ll have crisp fall days to enjoy the sights and world-class restaurants, shopping and historical attraction unique to this great American city. Tack on a day or two to enjoy Boston’s New England charm … and maybe a succulent lobster supper as well.
The rules on QMS and complaint management change 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.
Exercise B1 – Preliminary Analysis of Complaint Implications
Participants review example complaints to determine if subsequent processes, such as adverse event reporting, apply. This exercise applies the processes broadly, deferring the details for subsequent workshop sessions.
Exercise C1 – Service Record Analysis to Detect Complaints
Participants review examples of servicing activities to determine if the information includes a complaint.
Exercise D1 – Complaint Classification
Participants review examples of complaints and classify them using the multiple classification schemes from the regulatory systems.
Exercise E1 – Complaint Process Analysis
Participants analyze complaints to determine the need to update the risk management file and the need to report to the EU.
Exercise F1 – Adverse Event Reportability
Participants review examples of complaints that may be reportable as adverse events, determine reportability in various regulatory regions, and determine the appropriate timelines.
Exercise G1 – Complaints Requiring Corrective Action
Participants examine complaint examples to determine the need for corrective action and identify the required implementation steps and records.
Exercise H1 – Complaints Requiring Design Changes
Participants review complaint examples, determine the need for design changes, and identify required implementation steps and records.
Exercise I1 – Field Action Determination
Participants review potential conditions for field actions arising from complaints and determine the reporting requirements and methods for each of the regulatory regions under consideration.
Exercise J1 – Determining the Need for a Regulatory Submission
Participants review design changes resulting from complaints and determine the need, method, and records for each of the regulatory regions under consideration.
- Slides from PowerPoint presentations
- Interactive exercise worksheets
- Copies of relevant guidances and regulations