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

Event Details

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

Time: July 2, 2015 at 9am to July 3, 2015 at 6pm
Location: DoubleTree by Hilton Hotel San Francisco Airport
Street: 835 Airport Blvd., Burlingame CA 94010-9949
City/Town: San Francisco
Website or Map: https://www.globalcompliancep…
Phone: 18004479407
Event Type: food, fda, medical, device, defence, and, navy, aerospace, mining
Organized By: GlobalCompliancePanel
Latest Activity: Apr 22, 2015

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Event Description

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.

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
  • All senior managers
  • All Hardware engineers and managers
  • Production staff
  • R&D staff
  • Quality Assurance staff
  • Regulatory staff
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

Instructor Profile: 

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. 

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

support@globalcompliancepanel.com          

http://www.globalcompliancepanel.com

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

 

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