An Easy to Implement Integrated Risk Management Approach Compliant with ISO 14971

Website http://www.onlinecompliancepanel.com/webinar/RiskManagementApproach-501072/OCT-2015-ES | Edit Freely

Category Risk Management, ISO 14971, FDA, ISO 14971 guidelines, Hazard Analysis

Deadline: October 28, 2015 | Date: October 29, 2015

Venue/Country: online Webinar, U.S.A

Updated: 2015-10-07 13:56:44 (GMT+9)

Call For Papers - CFP

Instructor: Mercedes Massana

Product ID: 501072

Level: Intermediate

Objectives of the Presentation

How are risk management activities integrated throughout the development process

The roles that Hazard Analysis, FTA, FMEA, HAZOP and PFMEA play in an Integrated Risk Management Process

How to control and verify risk mitigations

How to perform a Risk Benefit Analysis

The importance of maintaining Risk Management documents in the Post Production era

What information to include in the Risk Management Plan and Report for better auditability

How to integrate Risk Management with CAPA, Complaints and Non-Conformance processes

Why Should you Attend

ISO 14971 Medical devices - Application of risk management to medical devices is a voluntary standard that medical device manufacturers should incorporate into their design and development process in order to ensure medical devices designed are safe and effective. The FDA now also recognizes ISO14971, and can audit to it if manufacturer's claim they conform to it. Although ISO 14971 has been in place since 1998, many companies still find it difficult to properly interpret the requirements of the standards and having a risk management process which is not helpful in designing robust, safe medical devices.

Who can Benefit

This webinar will provide a methodology that medical device companies can use in establishing a risk management process that is integrated with their product development process. The employees who will benefit include:

Risk Managers

Systems engineers responsible for developing requirements

Software Developers

Test Engineers

Quality System auditors

Engineering Managers and Personnel

Regulatory Affairs

For Registration -

http://www.onlinecompliancepanel.com/webinar/RiskManagementApproach-501072/OCT-2015-ES

Note : Use coupon code 1371 and get 10% off on Registration