Seminar on "Applying ISO14971:2012 and IEC62304 - A Guide to Practical Risk Management" by Markus Weber
The course will introduce the core elements of risk management with emphasis on the application of risk management principles and requirements to the medical device development cycle.
Berlin, Germany , October 23, 2014 (Newswire.com) - GlobalCompliancePanel Announces Seminar on “Applying ISO14971:2012 and IEC62304 - A Guide to Practical Risk Management”. Markus Weber Principal Consultant with System Safety, Inc. will be the speaker at this two-day session.
GlobalCompliancePanel, a leading provider of regulatory compliance trainings for a wide range of industries, will organize a two-day seminar in Berlin, Germany on October 23 and 24. The topic of this seminar is “Applying ISO14971:2012 and IEC62304 - A Guide to Practical Risk Management”.
The course is mainly based on international consensus requirements such as ISO14971, IEC62366 and IEC62304. It will cover European (MDD), US (FDA) and international risk management requirements from a regulatory and practitioner's perspective.
John Robinson, Event Manager
Course, “Applying ISO14971:2012 and IEC62304 - A Guide to Practical Risk Management” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
What the seminar is about:
The course will introduce the core elements of risk management with emphasis on the application of risk management principles and requirements to the medical device development cycle.
The course will highlight the ways by which to implement risk management into the development and maintenance process. The speaker will make this session interesting and effective by using real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking.
This seminar will address the system level issues of risk management as well as the increasingly important software and usability related issues of critical systems. It will offer participants ways by which to comply with regulatory requirements with minimized overhead and resource burden. The speaker will introduce the concept of an assurance case to make the combined effort to design, implement and verify a safe device transparent effective.
The course is mainly based on international consensus requirements such as ISO14971, IEC62366 and IEC62304. It will cover European (MDD), US (FDA) and international risk management requirements from a regulatory and practitioner's perspective.
This seminar will benefit the following professionals:
o {C}Senior quality managers
o {C}Quality professionals
o {C}Regulatory professionals
o {C}Compliance professionals
o {C}Project managers
o {C}Design engineers
o {C}Software engineers
o {C}Process owners
o {C}Quality engineers
o {C}Quality auditors
o {C}Medical affairs
o {C}Legal Professionals
Location details:
The venue for this seminar will be announced soon.
Date: October 23 and 28, 9:00 AM to 6:00 PM.
Registration Cost: $1,595.00 per delegate
Early bird discounts: Register now and save $200. (Early Bird)
Until September 15, Early Bird Price: $1,595.00; From September 16 to October 25, Regular Price: $1,795.00.
To register by P.O/Check, fax us at 302 288 6884 or mail us at [email protected]
Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
About the Speaker:
Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV.
Since 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms.
About GlobalCompliancePanel:
GlobalCompliancePanel (GCP) is a specialized offering from NetZealous LLC, a Technology and Business Process Solutions and Services Company registered in Fremont, CA. It is a fountainhead for Continuous Professional Education, compliance training and consulting. GCP offers a broad range of high quality regulatory and compliance-related services relating to Medical Devices, Pharmaceutical, FDA, Food, PCI industries, and SOX. Some of the Governing Areas its webinars cover are GxP (Manufacturing/Clinical/Lab), EU and ISO.
With trainings that are focused and relevant, GlobalCompliancePanel seeks to serve as a bridge in the area of continuous professional education for regulatory and compliance-related fields.
Contact Information:
Event Coordinator
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: [email protected]
Website: https://www.globalcompliancepanel.com
LIVE CHAT SUPPORT- http://www.globalcompliancepanel.com/chat/client.php
GlobalCompliancePanel
NetZealous LLC,
161| Mission Falls Lane| Suite 216, Fremont| CA 94539
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