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Designing for Safety to avoid Automobiles Recalls
A Live Webinar by Dev Raheja
Dev Raheja
President
Patient System Safety
Date and Time : Thursday, August 7, 2014
10:00 AM PDT | 01:00 PM EDT
About Dev Raheja:
Dev Raheja, MS,CSP, author of the forthcoming book Preventing Medical Device Recalls, 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 and is Senior Member of IEEE. Currently he is an Adjunct
Professor at the Florida Tech for its BBA degree in Healthcare Management, has authored two more
books Assurance Technologies Principles and Practices, and Safer Hospital Caret. He has received
several industry awards including the Scientific Achievement Award and Educator-of-the Year Award
from System Safety Society. He is a former National Malcolm Baldrige Quality Award Examiner in the
first batch of examiners. He has done seminars on Risk Management, Process Validation, Software
Reliability,Software Safety, Design Control, and Corrective and Preventive Action (CAPA) System.
Phone Number: 510-857-5896 | Fax Number : 510-509-9659 | Address : 38868 Salmon Ter, Fremont California94536 USA | susanpartov@onlinecompliancepanel.com
Copyright © 2014 OnlineCompliancePanel.com
Missed the Live session!!!
We have it in our archives
order a copy today
To register Click Here
Phone Number: 510-857-5896 | Fax Number : 510-509-9659 | Address : 38868 Salmon Ter, Fremont California94536 USA | susanpartov@onlinecompliancepanel.com
Copyright © 2014 OnlineCompliancePanel.com
Program Objectives:
•Safety flaws in the product specifications
•Writing good safety specifications
•Heuristics for designing for safety
•Safety analysis during early design
•Safety analysis tools
•Analyzing active safety
•Safety mitigation methods
•Designing out production flaws during early design
•Avoiding Failure Mode and Effects Analysis mistakes
•Fault Tree Analysis for complex systems and interfaces
•Software safety analysis
•Testing for safety
•Examples of best practices
Introductionto Preparing for Designing for Safety to avoid Automobiles Recalls
Over 30 million automobiles have been recalled in recent years involving the top companies including Toyota, GM, Honda and Ford. The problem is often the
flawed specifications, flawed production requirements, and lack of system integration.
This webinar is presented by the veteran consultant to automobile industry for over 25 years. The goal is to identify safety flaws in specifications by
implementing proactive process of identifying missing, vague and incomplete safety requirements and to understand design principles for avoiding active
safety mishaps throughout the entire design process.
Why Should you Attend:
Since the number of recalls currently is highest in the history of automobiles, senior management staff, all technical managers must lead in this effort so
there is vertical integration of safety knowledge instead of fragmented and uncoordinated responsibilities. If the whole design team attends together, this will
be a great opportunity to look at safety from different lenses.
Designing for Safety to avoid Automobiles Recalls
To register Click Here
Phone Number: 510-857-5896 | Fax Number : 510-509-9659 | Address : 38868 Salmon Ter, Fremont California94536 USA | susanpartov@onlinecompliancepanel.com
Copyright © 2014 OnlineCompliancePanel.com
Other Upcoming Live Webinar by Dev Raheja
System Safety Principles and Practices
Mil-Std-882 is the primary standard for teaching system safety engineering and management. NASA and all DoD contractors are required to
include this standard in the contracts.
Tuesday, July 15, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 minutes
Archived Webinar by Dev Raheja
Design for Safety
Designing a system right depends on how early we perform the hazard analysis, which analysis tools we use, and understanding of the system of systems. Most
aerospace contractors perform the hazard analysis too late and therefore have to depend on fixing one hazard at a time instead of fixing them before they
cause the mishaps.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.
Testing Medical Devices for Efficiency and Efficacy
Testing for safety, reliability, and durability are the most meaningful tests for adequacy of product, efficient performance (no down time, no recalls), and for the
highest value (gaining more loyal customers). Unfortunately such knowledge is very thin in the literature. This webinar is based on consultant’s 30 years hands
on experience with this knowledge.
RecordedSession Access recorded sessions for multiple participants unlimited viewing for 6 months.
Software Process Verification and Validation
The FDA's analysis of 3140 medical device recalls reveals that 7.7% of them are attributable to software failures. Of those software related recalls, 79%) were
caused by software defects that were introduced when changes were made to the software after its initial production and distribution. Software verification
and validation practices discussed in this guidance are a principal means of avoiding such defects and resultant recalls.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.
To register Click Here
Phone Number: 510-857-5896 | Fax Number : 510-509-9659 | Address : 38868 Salmon Ter, Fremont California94536 USA | susanpartov@onlinecompliancepanel.com
Copyright © 2014 OnlineCompliancePanel.com
For more details on our upcoming webinars , please visit:
Http://www.onlinecompliancepanel.com
To register Click Here

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Designing for safety to avoid automobiles recalls

  • 1. Designing for Safety to avoid Automobiles Recalls A Live Webinar by Dev Raheja Dev Raheja President Patient System Safety Date and Time : Thursday, August 7, 2014 10:00 AM PDT | 01:00 PM EDT About Dev Raheja: Dev Raheja, MS,CSP, author of the forthcoming book Preventing Medical Device Recalls, 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 and is Senior Member of IEEE. Currently he is an Adjunct Professor at the Florida Tech for its BBA degree in Healthcare Management, has authored two more books Assurance Technologies Principles and Practices, and Safer Hospital Caret. He has received several industry awards including the Scientific Achievement Award and Educator-of-the Year Award from System Safety Society. He is a former National Malcolm Baldrige Quality Award Examiner in the first batch of examiners. He has done seminars on Risk Management, Process Validation, Software Reliability,Software Safety, Design Control, and Corrective and Preventive Action (CAPA) System. Phone Number: 510-857-5896 | Fax Number : 510-509-9659 | Address : 38868 Salmon Ter, Fremont California94536 USA | susanpartov@onlinecompliancepanel.com Copyright © 2014 OnlineCompliancePanel.com Missed the Live session!!! We have it in our archives order a copy today To register Click Here
  • 2. Phone Number: 510-857-5896 | Fax Number : 510-509-9659 | Address : 38868 Salmon Ter, Fremont California94536 USA | susanpartov@onlinecompliancepanel.com Copyright © 2014 OnlineCompliancePanel.com Program Objectives: •Safety flaws in the product specifications •Writing good safety specifications •Heuristics for designing for safety •Safety analysis during early design •Safety analysis tools •Analyzing active safety •Safety mitigation methods •Designing out production flaws during early design •Avoiding Failure Mode and Effects Analysis mistakes •Fault Tree Analysis for complex systems and interfaces •Software safety analysis •Testing for safety •Examples of best practices Introductionto Preparing for Designing for Safety to avoid Automobiles Recalls Over 30 million automobiles have been recalled in recent years involving the top companies including Toyota, GM, Honda and Ford. The problem is often the flawed specifications, flawed production requirements, and lack of system integration. This webinar is presented by the veteran consultant to automobile industry for over 25 years. The goal is to identify safety flaws in specifications by implementing proactive process of identifying missing, vague and incomplete safety requirements and to understand design principles for avoiding active safety mishaps throughout the entire design process. Why Should you Attend: Since the number of recalls currently is highest in the history of automobiles, senior management staff, all technical managers must lead in this effort so there is vertical integration of safety knowledge instead of fragmented and uncoordinated responsibilities. If the whole design team attends together, this will be a great opportunity to look at safety from different lenses. Designing for Safety to avoid Automobiles Recalls To register Click Here
  • 3. Phone Number: 510-857-5896 | Fax Number : 510-509-9659 | Address : 38868 Salmon Ter, Fremont California94536 USA | susanpartov@onlinecompliancepanel.com Copyright © 2014 OnlineCompliancePanel.com Other Upcoming Live Webinar by Dev Raheja System Safety Principles and Practices Mil-Std-882 is the primary standard for teaching system safety engineering and management. NASA and all DoD contractors are required to include this standard in the contracts. Tuesday, July 15, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 minutes Archived Webinar by Dev Raheja Design for Safety Designing a system right depends on how early we perform the hazard analysis, which analysis tools we use, and understanding of the system of systems. Most aerospace contractors perform the hazard analysis too late and therefore have to depend on fixing one hazard at a time instead of fixing them before they cause the mishaps. Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months. Testing Medical Devices for Efficiency and Efficacy Testing for safety, reliability, and durability are the most meaningful tests for adequacy of product, efficient performance (no down time, no recalls), and for the highest value (gaining more loyal customers). Unfortunately such knowledge is very thin in the literature. This webinar is based on consultant’s 30 years hands on experience with this knowledge. RecordedSession Access recorded sessions for multiple participants unlimited viewing for 6 months. Software Process Verification and Validation The FDA's analysis of 3140 medical device recalls reveals that 7.7% of them are attributable to software failures. Of those software related recalls, 79%) were caused by software defects that were introduced when changes were made to the software after its initial production and distribution. Software verification and validation practices discussed in this guidance are a principal means of avoiding such defects and resultant recalls. Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months. To register Click Here
  • 4. Phone Number: 510-857-5896 | Fax Number : 510-509-9659 | Address : 38868 Salmon Ter, Fremont California94536 USA | susanpartov@onlinecompliancepanel.com Copyright © 2014 OnlineCompliancePanel.com For more details on our upcoming webinars , please visit: Http://www.onlinecompliancepanel.com To register Click Here