risk management in medical devices industry seminar brochure

8/2/2019 Risk Management in Medical Devices Industry Seminar Brochure

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USA Seminar 2012 at Boston

Risk Management inMedical Devices Industry

Markus Weberby

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 ITControl & 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.

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Markus WeberPrincipal Consultant, System Safety Inc.


bout Speaker:

arkus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk

anagement for critical medical devices.

e graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding

ystem Safety, Inc., he was a software safety engineer for the German approval agency, TUV.

nce 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory

ompliance issues, specifically for active and software-controlled devices.

conjunction with the FDA, he has published works on risk management issues and software-related risk

itigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms.

April 12th and 13th, 2012 at Boston

Will be announced soon

Date and Venue:

ast Seminars


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eminar Content: Conference timings: 9 AM PDT to 5 PM PDT

ay 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 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

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

hy should you attend:ps, incorrect or incomplete implementation can delay or make the certification/approval of products impossible. Most activities cannot be retroactively

rformed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of

oduct development is therefore imperative.

e course will introduce the main elements of risk management and the application of risk management principles and requirements to the medical device

velopment cycle. Risk management has become the method of choice to ensure an effective and safety oriented device development. International

nsensus,reflected in globally applicable standard requirements, has led to risk management as a mandatory component of almost any activity in the

edical device industry.


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ow to Register:

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

Contact Information:Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884

Email: [email protected]

GlobalCompliancePanel

NetZealous

1000 N West Street,

Suite 1200, Wilmington,DE 19801..

Kindly get in touch with us forany help or information.

Look forward to meeting youat the seminar

Team GlobalCompliancePanel


. Learning Objectives

. Participation certificates

. Interactive sessions with the US expert

. Post event email assistance to your queries.

. Special price on future purchase of web based trainings.

. Special price on future consulting or expertise services.

. Special price on future seminars by GlobalCompliancePanel.

Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog,

notepad and pen.

. Networking with industry's top notch professionals

Companies that will benefit:† Midsize medical device

companies

† Contract development companies

† Start-up and virtual medicaldevice companies

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)

-----------------------------------------

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

£ Regulatory Affairs Professionals

£ Quality Management Specialists

£ Drug Safety and Pharmacovigilance

£ Regulatory Affairs£ Clinical Development

£ Executives (including C-Level) with any

legal responsibility for drug safety

What you get:

risk management in medical devices industry seminar brochure

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