When one of your products triggers a customer complaint, you respond pronto. You dot the i’s and cross the t’s. You think you’ve made all the right moves, but chances are …
… you haven’t.
Worse, you may have inadvertently exposed your company to sanctions. Penalty letters … design changes … new UDI-DI … correction/removal … new 510(k) … all are possible.
Regardless of where you base your operation — the U.S., the EU or Canada — the problems are the same. Your company quietly changes even one long-standing practice and presto, you find yourself facing a punishing sanction.
You need a system. You need a plan. You need:
Medical Device Complaint Management
Building a Robust System to Meet Global Requirements
Mark your calendar for Boston in February, when FDAnews and Ombu Enterprises host an all-new two-day workshop that’ll transform your device company into a well-oiled complaint management machine.
You start with a hypothetical complaint, then trace it through the regulatory system. First come lectures, then interactive exercises — 11 of them over two days. You find yourself out of your chair and engaging with devicemakers like yourself — from the E.U., Canada and all across the U.S. — confronting and solving shared problems.
At the conclusion of each small-group exercise, you take a test. But not to worry — you can’t fail. Answers will be provided, plus proven solutions to take home and apply in your operation. We know of no other workshop providing such fine-grained level of interactivity, not to mention solutions you can put into effect — at once.
Your mentor is Dan O’Leary, a 30-year veteran of device quality compliance and five-star presenter. Mr. O’Leary is a master at working with devicemakers large and small to apply proven methods that build end-to-end complaint management systems.
Here’s just a taste of topics you’ll cover:
- The role of Unique Device Identification (UDI) in complaints and adverse event reporting
- Regulatory reporting requirements in three major markets: U.S., EU, Canada
- Understanding why the complaint source (Facebook, Twitter, email, phone call) is not your chief concern — it’s how you handle the communication
- Proper use of corrective action in complaint management, including statistical analysis
- Developing a complaint classification system that links to the risk management file
- Analysis methods to determine impact of design changes on regulatory requirements
- Planning field actions and making regulatory reports
- And much more
In your fast-changing world, facing multiple regulatory bodies with complex and ever-changing rules, an effective complaint management program is a must. Don’t let an inefficient, outmoded complaint management system bring you down – not when help is at hand. Sign up now.
This workshop helps you understand the regulatory system by starting with a complaint and tracing it through the various regulations, including interactions with regulatory agencies. Complaints are an unrecognized problem in a company’s marketed product. Depending on the nature of the complaint, it could lead to corrective action, design changes, new UDI-DI, correction & removal, or even a new 510(k). Using past experience and interactive exercises, this workshop teaches attendees how to deal with complaints and their implications throughout the entire regulatory structure in the US, EU, and Canada.
When one of your medical devices triggers a complaint, you respond immediately. You dot each i and cross each t. You think you’ve taken every prescribed step.
But complaint management is ever changing. Recently there’s been a big focus on customer complaints through a company’s social medium channels. Should your focus be on the complaint itself or the channel it was submitted through?
And despite all your hard work and focus on managing complaints, you and your colleagues still receive a Warning Letter. What’s going wrong?
What you may not realize is that FDA scrutiny can probe every aspect of your operation — customer service, field servicing, sales, device reporting, CA&PA, design change, corrections and removals, and more.
You need a system wide solution — one that turns your entire operation into a well-oiled complaint-handling machine. If you aren’t sure how to pull it off … FDAnews has created a one-of-a-kind workshop to help.
Using a combination of lectures and interactive exercises that will get you out of your chair and, working in small groups, this workshop will guide you through how to assure you’re focusing on ALL the areas that the FDA looks to hunt and peek within.
Dan O’Leary — a 30-year veteran of device quality compliance — is a master at working with companies large and small to apply proven methods to build end-to-end complaint management systems.
Through a combination of presentations and small group exercises Dan leads attendees through their toughest problems. At the conclusion of each presentation and exercise a “test” will take place, answers will be provided and attendees will have proven solutions they can take back to their operations. No other workshop provides this level of interactivity and take-home solutions.
Course Binder Materials:
- Full slides from the PowerPoint presentations
- A copy of each interactive exercise worksheet as well as answer keys
- An annotated version of MDR sections regulation based on recent Warning Letters
- An Excel worksheet that helps analyze the FDA regulations. It has a series of questions that start with a complaint and follow the reporting and record keeping decisions to help understand the integrated requirements spread across different parts of the regulations.
- FDA guidance on Medical Device Reporting
- FDA draft guidance on Medical Device Reporting
- Comparison of MDR Rule Changes
- FDA guidance on Enhancements and Recalls
- Comparison Part 7 and Part 806 definitions
- FDA guidance document on 510(k) changes
- MEDDEV document on the Vigilance System
- Health Canada document on Medical Device Problem Reporting