Welcome!

News Feed Item

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
www.fdanews.com/MDComplaintWorkshop   

(Photo: http://photos.prnewswire.com/prnh/20140122/MN50888)

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
www.fdanews.com/MDComplaintWorkshop

Tuition: $1,797

Easy Ways to Register
Online:      www.fdanews.com/MDComplaintWorkshop
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]

News distributed by PR Newswire iReach: https://ireach.prnewswire.com

SOURCE FDAnews

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
As the world moves toward more DevOps and Microservices, application deployment to the cloud ought to become a lot simpler. The Microservices architecture, which is the basis of many new age distributed systems such as OpenStack, NetFlix and so on, is at the heart of Cloud Foundry - a complete developer-oriented Platform as a Service (PaaS) that is IaaS agnostic and supports vCloud, OpenStack and AWS. Serverless computing is revolutionizing computing. In his session at 19th Cloud Expo, Raghav...
SYS-CON Events announced today Telecom Reseller has been named “Media Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
Aspose.Total for .NET is the most complete package of all file format APIs for .NET as offered by Aspose. It empowers developers to create, edit, render, print and convert between a wide range of popular document formats within any .NET, C#, ASP.NET and VB.NET applications. Aspose compiles all .NET APIs on a daily basis to ensure that it contains the most up to date versions of each of Aspose .NET APIs. If a new .NET API or a new version of existing APIs is released during the subscription peri...
SYS-CON Events announced today that StarNet Communications will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. StarNet Communications’ FastX is the industry first cloud-based remote X Windows emulator. Using standard Web browsers (FireFox, Chrome, Safari, etc.) users from around the world gain highly secure access to applications and data hosted on Linux-based servers in a central data center. ...
Smart Cities are here to stay, but for their promise to be delivered, the data they produce must not be put in new siloes. In his session at @ThingsExpo, Mathias Herberts, Co-founder and CTO of Cityzen Data, will deep dive into best practices that will ensure a successful smart city journey.
DevOps at Cloud Expo, taking place Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long dev...
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportuni...
StarNet Communications Corp has announced the addition of three Secure Remote Desktop modules to its flagship X-Win32 PC X server. The new modules enable X-Win32 to safely tunnel the remote desktops from Linux and Unix servers to the user’s PC over encrypted SSH. Traditionally, users of PC X servers deploy the XDMCP protocol to display remote desktop environments such as the Gnome and KDE desktops on Linux servers and the CDE environment on Solaris Unix machines. XDMCP is used primarily on comp...
There is growing need for data-driven applications and the need for digital platforms to build these apps. In his session at 19th Cloud Expo, Muddu Sudhakar, VP and GM of Security & IoT at Splunk, will cover different PaaS solutions and Big Data platforms that are available to build applications. In addition, AI and machine learning are creating new requirements that developers need in the building of next-gen apps. The next-generation digital platforms have some of the past platform needs a...
DevOps at Cloud Expo – being held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real results. Am...
Using new techniques of information modeling, indexing, and processing, new cloud-based systems can support cloud-based workloads previously not possible for high-throughput insurance, banking, and case-based applications. In his session at 18th Cloud Expo, John Newton, CTO, Founder and Chairman of Alfresco, described how to scale cloud-based content management repositories to store, manage, and retrieve billions of documents and related information with fast and linear scalability. He addres...
Fact: storage performance problems have only gotten more complicated, as applications not only have become largely virtualized, but also have moved to cloud-based infrastructures. Storage performance in virtualized environments isn’t just about IOPS anymore. Instead, you need to guarantee performance for individual VMs, helping applications maintain performance as the number of VMs continues to go up in real time. In his session at Cloud Expo, Dhiraj Sehgal, Product and Marketing at Tintri, wil...
Enterprises have forever faced challenges surrounding the sharing of their intellectual property. Emerging cloud adoption has made it more compelling for enterprises to digitize their content, making them available over a wide variety of devices across the Internet. In his session at 19th Cloud Expo, Santosh Ahuja, Director of Architecture at Impiger Technologies, will introduce various mechanisms provided by cloud service providers today to manage and share digital content in a secure manner....
SYS-CON Events announced today that eCube Systems, a leading provider of middleware modernization, integration, and management solutions, will exhibit at @DevOpsSummit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. eCube Systems offers a family of middleware evolution products and services that maximize return on technology investment by leveraging existing technical equity to meet evolving business needs. ...