SPEAKER

Global

CompliancePanel

2-day In-person Seminar:

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Knowledge, a Way Forward

How to Conduct Medical Device Risk Analysis Effectively

Dev Raheja Author - Safer Hospital Care (Taylor & Francis), Patient System Safety

Dev Raheja, MS,CSP, author of the books Preventing Medical Device Recalls and Safer Hospital Care, is an international risk management,

patient safety and quality assurance consultant for medical device, healthcare and aerospace industry for over 25 years. Prior to becoming

a consultant in 1982 he worked at GE Healthcare as Supervisor of Quality Assurance/Manager of Manufacturing Engineering, at Cooper

Industries as Chief Engineer, and at Booz-Allen & Hamilton as Risk Management consultant for variety of industries. His clients include

Johnson & Johnson, Siemens Medical Systems, Medtronic, Carl Zeiss, Warner-Lambert, Zimmer Holdings, and DuPont.

OVERVIEW

Course "How to Conduct Medical Device Risk Analysis

Effectively" has been pre-approved by as eligible for up to RAPS 12

credits towards a participant's RAC recertication upon full

completion.

Dev Raheja

July 2nd & 3rd, 2015

SFO, CA

9 AM to 6 PM

Why companies are prone to having past problems in new devices? One of the main reasons seems to be the weak cognition.It is usually

the result of short term memory, inattention to details, insufcient vigilance, or multitasking. This unsafe work propagates unknowingly

because of not engaged or disengaged employees, insufcient understanding of customer needs, splitting design among several design-

ers, and ineffective risk analysis.

Global

CompliancePanel

www.globalcompliancepanel.com All rights are reserved GlobalCompliancePanel.

Knowledge, a Way Forward

AGENDA

DAY ONE

Lecture 1: FDA requirements for risk analysis

Lecture 2: Principles of robust risk analysis

Lecture 3: Principles of efcient risk analysis

Lecture 4: Overview of ISO 14971

Lecture 5: Developing Risk Acceptance Criteria

Lecture 6: Guidance for conducting risk assessment

Lecture 7: Efcient team management

Lecture 8: Risk Analysis Using the PHA

Lecture 9: Identifying the potential hazards in the device, its use,

and foreseeable misuse

Lecture 10: Assigning the criticality based on the probability of the

harm and severity for each hazard

Lecture 11: Performing risk assessment

Lecture 12: Mitigating risks using world class practices

Lecture 13: Workshop on PHA

Lecture 14: Risk Analysis using system FMEA

Lecture 15: Workshop on system FMEA

Lecture 16: Component FMEA

Lecture 17: Process FMEA

Lecture 18: Maintenance FMEA

DAY TWO

WHY SHOULD YOU ATTEND:

You have to do risk analysis using the tools in ISO 14971. It is one of the rst things FDA will ask for! It is required by law (21 CFR Section

820) and appears on regulatory submission checklists. In addition, it will help dene testing that should be done to prove the safety of your

device. You can also eliminate costs associated with recalls lawsuits.

Risk assessment has to be done throughout the products lifecycle. According to ISO 14971, the manufacturer is required to establish,

document, and maintain the process for identifying hazards, estimating and evaluating associated risks, controlling these risks, and

monitoring the effectiveness of controls as long as the product is in use.

Lecture 1: Workshop on Component FMEA

Lecture 2: Risk Analysis Using the FTA

Lecture 3: Workshop on FTA

Lecture 4: Design improvements through FTA

Lecture 5: Device alarms requirements

Lecture 6: Hazard Analysis and Critical Control Point (HACCP)

analysis

Lecture 7: Workshop on HACCP

Lecture 8: HAZOP (Hazard Operability studies)

Lecture 9: Controlling device software risks

Lecture 10: Production and post-production risk controls

Lecture 11: Paradigms for efcient risk analysis

Lecture 12: Managing Residual Risks

Lecture 13: Maintaining effectiveness of controls during risk

analysis, risk evaluation and risk Control

Lecture 14: Maintaining effectiveness of controls in production

and post production information

Lecture 15: Management responsibility

Lecture 16: FDA documentation requirements

Lecture 17: Summary

Global

CompliancePanel

www.globalcompliancepanel.com All rights are reserved GlobalCompliancePanel.

Knowledge, a Way Forward

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

What you get

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Get fabulous discounts by participating in groups of two or more.

Price for One Delegate pass Price: $1,295.00

Register now and save(Early Bird) (Early Bird) Price $200.

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