SPEAKER
Global
CompliancePanel
2-day In-person Seminar:
www.globalcompliancepanel.com All rights are reserved GlobalCompliancePanel.
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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Price for One Delegate pass Price: $1,295.00
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Pricing List
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