Location: Webinar
Date: April 13, 2015, Monday: 1:00 PM EST
Duration : 90 Mins

Speaker: Dev Raheja, MS,CSP

Dev Raheja, MS,CSP, author of the  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.

Course Description:

Majority of the recent FDA recalls are software related. Perhaps most striking is the fact that one-third faced multiple recalls. It is a reminder that recalls can happen to any company—especially as more and more companies turn to complex technologies. While most standards are helpful, they can be considered only minimum requirements where self interest prevails. Even in healthcare where compliance to standards is at highest level, many patients die from devices errors in software designs, usually blamed on user errors. Understanding how mishaps can happen before they happen and preventing them by design is the key. Verification and validation helps in achieving the ultra-high software reliability.

Course Objectives:

The legal system, The FDA, and the European standards require the device to be safe as long as it is in use. Therefore high reliability is an obvious requirement. Besides, it is a value proposition for the business: zero warranty costs, safe customers, more loyal customers, and more sales.

The FDA reviews the results of the performance tests during pre-market approvals, and in complaint investigations. Therefore a thorough understanding of designing device for reliable and safe performance is critical for efficient business strategy.

Outline:

·         Regulatory requirements on  software risk management

·         Paradigms for efficiency and cost reduction

·         Identifying unknown risks

·         Design control is the key to good software requirements

·         Developing design control plan

·         Principles of software verification

·         Developing verification plan

·         Principles of software validation

·         Developing  validation plan

MANAGEMT REPORTS

Target Audience:

• Senior management

• Entire software engineering staff

• All hardware engineers

• All technical managers

• Test engineering staff

• Regulatory affairs professionals

• Marketing Managers

• Service managers

• Project Managers and engineers

• Quality Assurance staff

• IT professionals looking to make the design process efficient

Please Click hear for AGENDA

To Enroll for This Program today  please click hear

Thank you & Regards,

Sean Sharpe

Senior Associate – Operations & Customer Services

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