Seminar on How to Conduct Medical Device Risk Analysis Effectively at SFO, CA

Overview:

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, insufficient vigilance, or multitasking. This unsafe work propagates unknowingly because of not engaged or disengaged employees, insufficient understanding of customer needs, splitting design among several designers, and ineffective risk analysis. Another big reason is that ineffective device management procedures often touted as 'best practices', are like a bad virus with long incubation period and no early warning, resulting into sudden catastrophic malfunction of the device. Most companies still hold individuals responsible for mistakes instead of fixing the management process.

Marketing has the advantage of helping prevent past mistakes and improve efficiency of the device design. They have records of customer complaints for years. They even have knowledge of what problems exist on similar devices because they hear them from customers during marketing efforts. They need to be involved throughout the life cycle starting with the concept design.

The goal is to develop and implement risk balance throughout the design, manufacturing, installation and device use process. It includes FDA guidance on Incorporating human factors into risk and FDA guidance on premarketing risk assessment. The important areas include assessing resources requires, a good policy, good methods for assessing the effectiveness including the effectiveness of the management policy, qualifications of personnel.

Why should you attend?

You have to do risk analysis using the tools in ISO 14971. It is one of the first 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 define 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 product's 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.

Areas Covered in the Session:

·         FDA requirements

·         Risk analysis process

·         Assessing criticality of risks

·         Qualifications of personnel

·         Failure Mode and Effects Analysis

·         Preliminary Hazard Analysis

·         Fault Tree Analysis

·         Hazard Analysis for Critical Control Points

·         Paradigms for efficiency and effectiveness

·         Documentation requirements

·         Risk assessment

·         Risk evaluation

·         World class best practices

·         Case histories

Who Will Benefit:

·         All senior managers

·         All Hardware engineers and managers

·         Production staff

·         R&D; staff

·         Quality Assurance staff

·         Regulatory staff

·         Marketing staff

·         Servicing staff

·         Product Safety staff

·         Manufacturing Engineering staff

Agenda:

Day One:

·         FDA requirements for risk analysis

·         Principles of robust risk analysis

·         Principles of efficient risk analysis

·         Overview of ISO 14971

·         Developing Risk Acceptance Criteria

·         Guidance for conducting risk assessment

·         Efficient team management

·         Risk Analysis Using the PHA

·         Identifying the potential haz-ards in the device, its use, and foreseeable misuse

·         Assigning the criticality based on the probability of the harm and severity for each hazard

·         Performing risk assessment

·         Mitigating risks using world class practices

·         Workshop on PHA

·         Risk Analysis using system FMEA

·         Workshop on system FMEA

·         Component FMEA

·         Process FMEA

·         Maintenance FMEA

Day Two

·         Workshop on Component FMEA

·         Risk Analysis Using the FTA

·         Workshop on FTA

·         Design improvements through FTA

·         Device alarms requirements

·         Hazard Analysis and Critical Control Point (HACCP) analysis

·         Workshop on HACCP

·         HAZOP (Hazard Operability studies)

·         Controlling device software risks

·         Controlling off-the-shelf software risks

·         Production and post-production risk controls

·         Paradigms for efficient risk analysis

·         Managing Residual Risks

·         Maintaining effectiveness of controls during risk analysis, risk evaluation and risk Control

·         Maintaining effectiveness of controls in production and post-production information

·         Management responsibility

·         FDA documentation requirements

·         Summary

Instructor Profile:

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. He has served as Adjunct Professor at the University of Maryland for five years for its PhD program in Reliability Engineering. He is a Fellow of American Society for Quality and recipient of its Austin Bonis Award for Reliability Education Advancement, former chair of the Reliability Division, and member of the Biomedical Division. 

 

Location: SFO, CA        Date: July 2nd & 3rd, 2015        Time: 8:00 AM to 4:00 PM 

Venue: DoubleTree by Hilton Hotel San Francisco Airport

Venue Address: 835 Airport Blvd., Burlingame CA 94010-9949

Price: $1,295.00

(Seminar for One Delegate)

Register now and save $200. (Early Bird)

Until May 15, Early Bird Price: $1,295.00

From May 16 to June 30, Regular Price: $1,495.00

Registration Details:

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA         

USA Phone: 1-800-447-9407

Fax: 302-288-6884

webinars@globalcompliancepanel.com

support@globalcompliancepanel.com          

http://www.globalcompliancepanel.com

Event Link - http://bit.ly/Medical-Device-Risk-Analysis-Effectively