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: firstname.lastname@example.org 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.. www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.