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risk management in medical devices industry US seminar

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					                                                                                                                    Net Zealous




    USA Seminar 2012 at Boston

    Risk Management in
    Medical Devices Industry
    by   Markus Weber
    On 12th and 13th April, 2012 at Boston




About GlobalCompliancePanel:

GlobalCompliancePanel is an online training provider of Regulatory and Quality compliance. We deliver a broad range of high
quality regulatory and compliance-related services.

At GlobalCompliancePanel, we offer extensive and high quality training for Risk Management, Regulatory Compliances,
Corporate Governance and Quality Management. We have been serving our customers for the past three years, during which we
have successfully completed over 350 training courses, from which more than 15,000 professionals have benefited. Many of these
sessions have had over 100 participants. Over 100 well-versed Experts from various industries with several decades of collective
experience are associated with us.

Our services benefit the Medical Devices, Pharmaceutical, Bio Technology, Food Safety, Financial Accounting Standards, and IT
Control & PCI Industries. Our clients can choose from any of these mediums - online seminars that are live, recorded or for group
viewing, workshops, live seminars and conferences, onsite trainings and consulting. Our clientele includes companies such as
J&J, Pfizer, Sanofi Aventis, Pall Corp, Abbott, Merck, Bayer, and Roche, some of which are Fortune 500 companies.


www.globalcompliancepanel.com                                                All rights are reserved © GlobalCompliancePanel.
            USA Seminar 2012 at Boston

              Markus Weber
              Principal Consultant, System Safety Inc.

About 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.




Past Seminars




                                                         Date and Venue:
                                                         April 12th and 13th, 2012 at Boston

                                                         Will be announced soon
                                                                                            USA Seminar 2012 at Boston
Seminar Content:                                                                                           Conference timings: 9 AM PDT to 5 PM PDT

Why should you attend:
Gaps, incorrect or incomplete implementation can delay or make the certification/approval of products impossible. Most activities cannot be retroactively
performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of
product development is therefore imperative.

The course will introduce the main elements of risk management and the application of risk management principles and requirements to the medical device
development cycle. Risk management has become the method of choice to ensure an effective and safety oriented device development. International
consensus,reflected in globally applicable standard requirements, has led to risk management as a mandatory component of almost any activity in the
medical device industry.
Day 1 - 12th April 2012                                                           Day 2 - 13th April 2012


   Lecture 1                                                                         Lecture 3
                                                                                     „ Usability as hazard source and mitigation
   „ Risk Management Planning
                                                                                     „ Safety requirements
   „ Risk Management Life Cycle
                                                                                     „ Hazard mitigation traceability
   „ Hazard Identification                                                           „ Verification planning

   „ Hazard Domains                                                                  „ Architectures, redundancy and diversity
                                                                                     „ Failure mode and effect analysis / FTA
   „ Hazard Latency Issues
                                                                                     „ Verification strategies
   „ Risk Rating Methods                                                             „ System validation / mitigation validation
   „ Initial (unmitigated) Risk Assessment                                           „ Q&A Session

   „ Q&A Session
                                                                                     Lecture 4
   Lecture 2                                                                         „ Critical software issues

   „ Mitigation strategies and priorities                                            „ Software hazard mitigation strategies

                                                                                     „ Software item, unit and system definition
   „ Mitigation architectures
                                                                                     „ Software failures as hazard sources
   „ Alarm systems as mitigations
                                                                                     „ Software requirements and design specification
   „ Risk control bundles
                                                                                     „ Software tools and development environment
   „ Post mitigation risk                                                            „ Software unit and integration testing

   „ Residual risk                                                                   „ Real-time system challenges

                                                                                     „ Software verification and validation
   „ Safety Integrity levels
                                                                                     „ Mitigation traceability and effectiveness
   „ Q&A Session
                                                                                     „ Q&A Session


 www.globalcompliancepanel.com                                                                   All rights are reserved © GlobalCompliancePanel.
                                                                                   USA Seminar 2012 at Boston

What you get:
1. Learning Objectives
                                                                                          Pricing List:
2. Participation certificates                                                             1. Price for One Delegate pass
3. Interactive sessions with the US expert                                                   $1895
4. Post event email assistance to your queries.                                              (Between March 23th to April 25th)
5. Special price on future purchase of web based trainings.                               -----------------------------------------
6. Special price on future consulting or expertise services.                              2. Early bird price for one Delegate
7. Special price on future seminars by GlobalCompliancePanel.                                pass $1695
8. Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog,        (Between February 16th to March 22th)
    notepad and pen.                                                                      -----------------------------------------
9. Networking with industry's top notch professionals                                     3. For discounts on multiple
                                                                                             registrations, contact customer
                                                                                             care at 1800 447 9407
                                                  Companies that will benefit:
                                                  † Midsize medical device
                                                    companies                             Professionals who will benefit:
                                                                                          £ Pharmacoepidemiology
                                                  † Contract development companies
                                                                                          £ Regulatory Affairs
                                                  † Start-up and virtual medical
                                                                                          £ Clinical Safety Staff
                                                    device companies
                                                                                          £ Pharmacovigilance Specialists
                                                                                          £ Regulatory Affairs Professionals
How to Register:                                                                          £ Quality Management Specialists
                                                                                          £ Drug Safety and Pharmacovigilance
v   Register online. Use your American Express, Visa or MasterCard
                                                                                          £ Regulatory Affairs
v   For group discount of more than 5 attendees call 800-447-9407
                                                                                          £ Clinical Development
v   Call +1 - 800-447-9407 or Fax your PO: 302-288-6884                                   £ Executives (including C-Level) with any

v   Mail your check to: NetZealous LLC DBA GLOBALCOMPLAINCEPANEL,                           legal responsibility for drug safety
     6552 Palisades Dr. Centreville, VA 20121




    Contact Information:
    Event Coordinator
    Toll free: 1800 447 9407
                                                                                        Kindly get in touch with us for
    Fax: 302 288 6884
    Email: support@globalcompliancepanel.com
                                                                                           any help or information.
    GlobalCompliancePanel                                                               Look forward to meeting you
    NetZealous                                                                                  at the seminar
    1000 N West Street,                                                                 Team GlobalCompliancePanel
    Suite 1200, Wilmington,
    DE 19801..




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