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Compliance Training Panel.

Compliance Training Panel provides Quality trainings through their world class platform which enables the clients to discuss with industry experts and to gain related information.

Compliance Training Panel has been established by professionals in the field of Quality, Compliance Auditing and Health Care, Education & Finance with an objective to create an ecosystem that will deliver quality training's on compliance of various regulatory and legal requirements.

We are a US based organization specializing in online trainings in the form of Webinars and Seminars.

Failure Mode and Effects Analysis: Uses and Misuses
Description :
Failure Mode and Effect Analysis (FMEA), required for risk analysis, is one of the tools in the ISO 14971 risk management standard on medical devices. It can be used to assess the efficacy and efficiency of the device in actual use. Unfortunately is has been overly misused. The aim is to thoroughly review what can go wrong in use and what kind of misuses may be made. The device manufacturer must consider how to protect patients in case of human errors in the devices such as x-ray systems, ventilators and PCA pumps for pain control. Many patients have died from its inadvertent misuse. It is also important to consider supporting processes such as packaging, sterilization, shipping of wrong kits, and labeling. These have many risks associated with them that could adversely affect the performance of the device.

Objective :
This webinar covers how FMEAs are usually misused in medical devices, how to get most value from them. It aims at eliminating design defects, manufacturing defects, maintenance mistakes, and designing the device more human-centered so the device can conform to human needs instead the other way.

Areas Covered in the Session :
  • How FMEAs are usually misused?
  • The correct way to conduct FMEA
  • How to conduct FMEAs quickly, and efficiently,
  • How to develop elegant solutions to mitigate risks
  • How to get users involved in the FMEA
  • How to integrate FMEA in the risk management process
  • Eliminating design defects to reduce risks of recall
  • Eliminating manufacturing defects to reduce risk of recall
  • Eliminating maintenance mistakes
  • FMEA for design verification and validation
  • New paradigms for developing devices cheaper, better, and faster
Who Will Benefit:
  • Senior management
  • Entire engineering staff
  • Test engineering staff
  • Regulatory affairs professionals
  • Marketing Managers
  • Service managers
  • Project Managers and engineers
  • Quality Assurance staff
  • Product safety staff
About Speaker:
Dev Raheja, MS,CSP, is an international Risk Management and Quality Assurance consultant specializing in the field of Healthcare, medical device, and aerospace industry. He has held various positions in GE Healthcare, Cooper Industries and Booz-Allen & Hamilton. He is a trainer, author of the books Safer Hospital Care, Assurance Technologies Principles and Practices, and Design for Reliability. In his 25 years consulting experience he has conducted various training programs across various geographies. Currently he is an Adjunct Professor at the Florida Tech for its degree in Healthcare Management, and serves on the Patients and Families Advisory Council at Johns Hopkins Hospital. He is Associate Editor for Healthcare Safety for the Journal of System Safety, and is a member of the American College of Healthcare Executives.
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