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FDAnews Announces: Medical Device Complaint Management: Building a Robust System to Meet Global Requirement Workshop, March 11-12

FALLS CHURCH, Va., Jan. 22, 2014 /PRNewswire-iReach/ -- Medical Device Complaint Management
Building a Robust System to Meet Global Requirement
**Presented by FDAnews and Ombu Enterprises**
March 11-12, 2014Boston, MA   


When a product triggers a customer complaint, the devicemaker responds pronto. The i's are dotted and the t's crossed. The manufactures thinks it's made all the right moves, but chances are … it hasn't.

Worse, the company may inadvertently be exposed to sanctions. Penalty letters … design changes … new UDI-DI … correction/removal … new 510(k) … all are possible.

Regardless of where the operation is based — the U.S., the EU or Canada — the problems are the same. If the company quietly changes even one long-standing practice and presto, it finds itself facing a punishing sanction.

Device manufacturers need a system. They need a plan. They need:

Medical Device Complaint Management
Building a Robust System to Meet Global Requirements

Mark the calendar for Boston in March, when FDAnews and Ombu Enterprises host an all-new two-day workshop that'll transform a device company into a well-oiled complaint management machine.

Attendees start with a hypothetical complaint, then trace it through the regulatory system. First come lectures, then interactive exercises — 11 of them over two days. Attendees will find themselves out of the chair and engaging with devicemakers like them — from the E.U., Canada and all across the U.S. — confronting and solving shared problems.

At the conclusion of each small-group exercise, attendees take a test. But not to worry — they can't fail. Answers will be provided, plus proven solutions to take home and apply. There is no other workshop providing such fine-grained level of interactivity, not to mention solutions device manufacturers can put into effect — at once.

The workshop 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 covered:

  • 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 the chief concern — it's how the communication is handled
  • 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 this 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 the company down — not when help is at hand. Sign up now.

Meet Your Instructor
Dan O'Leary has more than 30 years' experience in quality, operations and program management in regulated industries, including aviation, defense, medical devices and clinical labs. Mr. O'Leary is President of Ombu Enterprises, LLC, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies.

Who Should Attend

  • Quality Managers
  • Regulatory Affairs Managers
  • Engineering Managers
  • Quality Engineers
  • Design Engineers
  • Project Managers involved in design and development
  • Specialists assigned to complaints, corrective actions, or medical device reporting
  • Recall coordinators
  • Medical staff evaluating risk, safety or effectiveness
  • General/corporate counsel

Course Binder Materials

  • Full slides from the PowerPoint presentations
  • Copies of each interactive exercise worksheet as well as an answer key for each exercise
  • A copy of 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.
  • Reference documents:
    • FDA draft guidance on medical device reporting
    • FDA draft guidance on corrections and removals
    • FDA guidance document on 510(k) changes
    • MEDDEV document on the vigilance system
    • Health Canada document on medical device problem reporting

Conference Details
Medical Device Complaint Management
Building a Robust System to Meet Global Requirement
**Presented by FDAnews and Ombu Enterprises**
March 11-12, 2014Boston, MA

Tuition: $1,797

Easy Ways to Register
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.

Media Contact: Michelle Butler, FDAnews, 703-538-7665, [email protected]

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