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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
Risk Management Planning Risk Management Life Cycle Hazard Identification Hazard Domains Hazard Latency Issues Risk Rating Methods Initial (unmitigated) Risk Assessment Q&A Session

Lecture 3
Usability as hazard source and mitigation Safety requirements Hazard mitigation traceability Verification planning Architectures, redundancy and diversity Failure mode and effect analysis / FTA Verification strategies System validation / mitigation validation Q&A Session

Lecture 4
Critical software issues Software hazard mitigation strategies Software item, unit and system definition Software failures as hazard sources Software requirements and design specification Software tools and development environment Software unit and integration testing Real-time system challenges Software verification and validation Mitigation traceability and effectiveness Q&A Session
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Lecture 2
Mitigation strategies and priorities Mitigation architectures Alarm systems as mitigations Risk control bundles Post mitigation risk Residual risk Safety Integrity levels Q&A Session

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USA Seminar 2012 at Boston


What you get:
1. Learning Objectives 2. Participation certificates 3. Interactive sessions with the US expert 4. Post event email assistance to your queries. 5. Special price on future purchase of web based trainings. 6. Special price on future consulting or expertise services. 7. Special price on future seminars by GlobalCompliancePanel. 8. Seminar Kit includes presentation handout, ID card, brochure, trainings catalog, notepad and pen. 9. Networking with industry's top notch professionals

Pricing List:
1. Price for One Delegate pass $1895
(Between March 23th to April 25th)

----------------------------------------2. Early bird price for one Delegate pass $1695


(Between February 16th to March 22th)

Companies that will benefit:


Midsize medical device

----------------------------------------3. For discounts on multiple registrations, contact customer care at 1800 447 9407 Professionals who will benefit:
Pharmacoepidemiology Regulatory Affairs Clinical Safety Staff Pharmacovigilance Specialists

companies
Contract development companies Start-up and virtual medical

device companies

How to Register:
v v v v

Regulatory Affairs Professionals Quality Management Specialists Drug Safety and Pharmacovigilance Regulatory Affairs Clinical Development Executives (including C-Level) with any

Register online. Use your American Express, Visa or MasterCard For group discount of more than 5 attendees call 800-447-9407 Call +1 - 800-447-9407 or Fax your PO: 302-288-6884 Mail your check to: NetZealous LLC DBA GLOBALCOMPLAINCEPANEL, 6552 Palisades Dr. Centreville, VA 20121

legal responsibility for drug safety

Contact Information:
Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com GlobalCompliancePanel NetZealous 1000 N West Street, Suite 1200, Wilmington, DE 19801..

Kindly get in touch with us for any help or information. Look forward to meeting you at the seminar Team GlobalCompliancePanel

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