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Subscribe NewsletterRisk Analysis: When does it start and When does it End
Product Id
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600046
Overview: As a result of attending this presentation, the attendee will receive an overview of Risk Analysis which can be applied to all varieties of Medical Devices in the marketplace today.
With the current atmosphere of the importance of product safety at the FDA, along with the worldwide emphasis of Post-Market Surveillance, the importance of a well established and maintained Risk Management Process is imperative for today’s medical device marketplace. There are many guidelines and standards associated with Risk management but none which are more recognized by the medical device industry as ISO 14971.
This presentation is entitled: "Risk Analysis: When Does it Start and When does it End". During participation in this webinar, the attendee will receive a brief overview of ISO 14971:2007 which is the recognized consensus standard for Risk Management. However, the most difficult and tedious part of a Risk management System is performance of Risk Analysis. By using real world examples, this presentation will provide a systematic approach to the Risk Analysis process providing a standardized set of categories to be used when risk analysis is performed. The main intention of Risk Analysis is to identify risks within a device design before the device has been prototyped so that the associated risks may be "Designed Out" of the device. Many audit deviations as well as adverse events can be linked to poor performance of risk analysis during the design process.
Another source of deviations is related to risk analysis on "Design Changes". Many times the introduction of design changes are not analyzed properly to identify the introduction of new risks associated with the change. This presentation will provide insight as to when the Risk Analysis process starts and when it is over. The majority of the presentation will focus on section 4.0 of the ISO14971 standard which is "Risk Analysis". The basis for performance of a Risk Analysis will be the use of Failure Modes Effect Analysis (FMEA). During the presentation the risk analysis focus will provide the attendee with a defined list of Hazard Categories, a recommended list of Potential Effects of Failure Modes, A list of Risk Controls (mitigations and remediation), and who is responsible for the risk control action. The importance of Risk Analysis of design changes will also be reviewed. In addition to these subjects, a review of Risk Benefit Analysis will also be provided. This will include when Risk Benefit Analysis is performed and some insight at to the judgment used. Segments of the Global Harmonization Task Force (GHTF) Study Group 3 document: Implementation of Risk Management Principles and Activities within a Quality Management System, which was published in May of 2005 will also be discussed.
With the current atmosphere of the importance of product safety at the FDA, along with the worldwide emphasis of Post-Market Surveillance, the importance of a well established and maintained Risk Management Process is imperative for today’s medical device marketplace. There are many guidelines and standards associated with Risk management but none which are more recognized by the medical device industry as ISO 14971.
This presentation is entitled: "Risk Analysis: When Does it Start and When does it End". During participation in this webinar, the attendee will receive a brief overview of ISO 14971:2007 which is the recognized consensus standard for Risk Management. However, the most difficult and tedious part of a Risk management System is performance of Risk Analysis. By using real world examples, this presentation will provide a systematic approach to the Risk Analysis process providing a standardized set of categories to be used when risk analysis is performed. The main intention of Risk Analysis is to identify risks within a device design before the device has been prototyped so that the associated risks may be "Designed Out" of the device. Many audit deviations as well as adverse events can be linked to poor performance of risk analysis during the design process.
Another source of deviations is related to risk analysis on "Design Changes". Many times the introduction of design changes are not analyzed properly to identify the introduction of new risks associated with the change. This presentation will provide insight as to when the Risk Analysis process starts and when it is over. The majority of the presentation will focus on section 4.0 of the ISO14971 standard which is "Risk Analysis". The basis for performance of a Risk Analysis will be the use of Failure Modes Effect Analysis (FMEA). During the presentation the risk analysis focus will provide the attendee with a defined list of Hazard Categories, a recommended list of Potential Effects of Failure Modes, A list of Risk Controls (mitigations and remediation), and who is responsible for the risk control action. The importance of Risk Analysis of design changes will also be reviewed. In addition to these subjects, a review of Risk Benefit Analysis will also be provided. This will include when Risk Benefit Analysis is performed and some insight at to the judgment used. Segments of the Global Harmonization Task Force (GHTF) Study Group 3 document: Implementation of Risk Management Principles and Activities within a Quality Management System, which was published in May of 2005 will also be discussed.
Areas Covered in the Session:
- Basic overview of ISO 14971:2003
- Concentration of Section 4.0: Risk Analysis Including:
- Potential Effects of Failure Modes
- Risk Controls (Mitigation and Remediation)
- Preferences for Mitigation
- Risk Control Responsibilities
- When is Risk Benefit Analysis Applicable
- Conclusions
Who Will Benefit:
- Design Engineers
- Quality Assurance Personnel
- Program Managers
- Manufacturing Engineers
- Regulatory Personnel
- Engineering Managers