World Conference Calendar

34364 Conferences

Failure Modes and Effects Analysis - An effective Risk Management Tool

Added by OCPcompliance on 2014-12-04

Conference Dates:

Start Date Start Date: 2015-01-22
Last Date Last Day: 2015-01-22
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2015-01-21

Conference Contact Info:

Contact Person Contact Person: David Jonathan Moses
Email Email:
Address Address: 38868 Salmon Ter, Fermont, California, 94536, United States
Phone Tel: 5105099659

Conference Description:

FMEA (Failure Mode Effects Analysis) has long been recognized as a valuable tool in risk assessment and should be considered as an integral part of risk management. FMEA has been used as part of Risk Analysis under the obsolete standard EN 1441 - Risk Analysis for Medical Devices. The term "Risk Analysis" is no longer appropriate for medical device manufacturers and has been replaced by "Risk Management".

EN 1441 is now a withdrawn standard and ISO 14971:2000 Medical Devices -- Application of Risk Management to Medical Devices has been the harmonized standard for risk assessment of medical devices under the medical devices directives and referred to in ISO 13485:2003. This presentation will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.

Why Should you Attend:
Getting through a regulatory audit and how to prepare for it, is vital for companies to know and often helps determine the direction of the audit. Preparation is key as well as knowing what inspectors will focus on and actions to avoid. This webinar will give attendees a template to use to help devise a training program to those responsible for meeting inspectors, the audit team, those who will deal with inspectors as well as upper management. Finally, after getting through an audit, observations made still need to be responded to and this webinar will give suggestions as to how best to address them.

Objectives of the Presentation:
Objectives of the presentation are to cover areas such as:
Risk Management vs.ISO 13485:2003
Risk Management & ISO 14971
FDA's Risk Management Requirements
Design Control Risk Management
Medical Device Directives & Risk Management
Who can Benefit:
Companies interested in understanding and implementing a quality management system that is universally accepted by regulatory authorities. Employees who will benefit include:
Quality & Regulatory Professionals
Quality System Auditors
Manufacturing & Design Engineers
Marketing Product Managers
About Company:

Online Compliance Panel creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holistic and effective. Online Compliance Panel largely emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices and market trends.

We strive to incorporate high standards in developing a culture facilitating exchange of ideas resulting in functional excellence. Online Compliance Panel believes in nurturing ideas and thought processes through innovative e-learning methodologies. Our products and services are designed to offer customized solutions to industry and market. We bridge the gap between experience and knowledge thus delivering original and creative content.

Our objectives of employing interactive mediums ensure effective communication and mutual exchange of ideas. Online Compliance Panel closely follows best practices and regulatory trends in the global compliance scenario. We also observe and communicate trends witnessed in FDA, ISO regulations, process and design validation. All updates and additions to important laws can be accessed by our customers in real time.

Toll free: +1-510-857-5896
OnlineCompliancePanel LLC,
38868 Salmon Ter,
Fremont, CA 94536, USA
Use For Registration:
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