FDAnews Announces - 1 Week Left to Register for Medical Device Risk Management: Prepare for the Winds of Change Feb. 19-20, 2019 Atlanta, GA

Gale force flags are flying - risk management international standards are under revision. Here's how to get prepared for the winds of change.

News provided by

FDANEWS

Feb 12, 2019, 13:00 ET

FALLS CHURCH, Va., Feb. 12, 2019 /PRNewswire-PRWeb/ -- Medical Device Risk Management
Prepare for the Winds of Change
**An interactive workshop from FDAnews and Ombu Enterprises**
Feb. 19-20, 2019
Atlanta, GA

https://www.fdanews.com/mdriskmanagement

One week left to register for Medical Device Risk Management: Prepare for the Winds of Change on Jan. 22

Risk management is just plain hard, complicated, conflicted, confusing. And it is getting even more complicated

The international standard is under revision. While the changes in the process are not intended as "major", the new standard adds new definitions, changes the clause numbering, introduces new requirements, changes many of the annexes, and moves them to a new document.

In a sister storm, the EU is in transition to new regulations. There are new concepts, new risk reduction requirements, and new applications. Two areas of impact are side-effects (residual risk) and benefit-risk analysis as a life-cycle requirement.

Risk management procedures will require a major overhaul.

FDAnews and Ombu Enterprises are here to help devicemakers prepare for the winds of change, with a two-day workshop designed to untangle every mystery of risk management and a path to full compliance. During the workshop attendees will:

  •     Learn the fundamental concepts of risk management
  •     Understand the regulatory structure including the US, Canada, the EU current state, and the EU future state
  •     Review recent FDA Warning Letters and understand how to avoid problems
  •     Learn the process flow in the new standard, ISO 14971:xxxx
  •     Understand the details of the EU variant, EN ISO 14971:xxxx including the five Z annexes
  •     Understand the risk management changes arising from the EU-MDR and EU-IVDR
  •     Review the potential relationship between the ISO 14971:xxxx Risk Management System (RMS) and an ISO 13485:2016 Quality Management System (QMS)
  •     Review the risk management audit tasks from the MDSAP Audit Model
  •     Understand the role of risk management in post-market surveillance

The risk management guide is Dan O'Leary, a favorite presenter at dozens of FDAnews-sponsored workshops. Dan provides the understanding and practical tools to join the disparate pieces into a coherent whole and create a solid foundation for the coming changes. Dan boasts more than 30 years' experience in quality, operations and program management in regulated industries including aviation, defense, medical devices and clinical labs.

Risk management affects nearly every aspect of medical device manufacture. Yet many devicemakers lag behind the curve, courting warning letters or worse. Get up to speed quickly and easily.

Reminder: Medical Device Risk Management: Prepare for the Winds of Change starts in one week.

Who Should Attend:
Here are just a few of the many executives who will benefit:

  •     Project managers involved in design and development
  •     Design engineers
  •     Quality engineers
  •     Manufacturing engineers
  •     Quality auditors
  •     Production managers
  •     Scientists involved in device research and development
  •     Medical staff evaluating risk, safety or effectiveness
  •     Quality or regulatory staff assigned to complaint, CAPA or MDR management
  •     Training personnel
  •     General/corporate counsel

Webinar Details:
Medical Device Risk Management
Prepare for the Winds of Change
**An interactive workshop from FDAnews and Ombu Enterprises**
Feb. 19-20, 2019
Atlanta, GA
https://www.fdanews.com/mdriskmanagement

Tuition:
Pricing: $1,797
Significant team discounts are available.

Easy Ways to Register:
Online: https://www.fdanews.com/mdriskmanagement
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.

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