is being presented by Susan Schenk, Clinical Development Services, Director, Operational Strategy & Planning, with Covance Inc. and airs on Thursday, October 14th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Managing and preventing risk is an integral part of clinical trial conduct in order to achieve high-quality data on time and on budget. However, industry data reveals that a large percentage of clinical trial budgets is allocated towards remediation, focused on fixing problems after they occur, rather than towards proactive activities to help predict and prevent costly errors. This audio conference showcases a complementary range of real-life examples of how to leverage sophisticated tools such as Failure Modes & Effects Analysis (FMEA) to proactively manage project-related risk.
However, in the project management arena, there is often a gap between the sophisticated tools and proactive approaches available to manage project-related risk, and the general level of understanding of how to deploy these tools.
Specifically addressing this issue, the audio conference aims to help close the gap by exploring a number of different ways to leverage theory into practice. Acknowledging the need for continuous mitigation of project-related risks, the speaker also demonstrates methods to overcome challenges that may occur mid-study, successfully absorbing and minimizing the impact to timelines and resources.
Showing posts with label failure mode. Show all posts
Showing posts with label failure mode. Show all posts
Wednesday, September 22, 2010
Tuesday, August 10, 2010
Failure Modes & Effects Analysis (FMEA)
is being presented by Angelo Scangas, President, of Quality Support Group, Inc. and airs on Tuesday, August 31st. For more details or to register for this event, please visit our site at www.fxconferences.com
Failure Modes and Effects Analysis (FMEA) is a powerful technique designed to help the engineer improve the quality and reliability of design. When properly used, FMEA provides numerous benefits, including improved product/process reliability and quality, increased customer satisfaction, early identification and elimination of potential product/process failure modes, and prioritization of product/process deficiencies. It also facilitates capturing engineering/organization knowledge, emphasizes problem prevention, documents risk and actions taken to reduce risk, and provides focus for improved testing and development.
Applying this technique serves to identify critical parameters and support the continual improvement of products and services. Doing a comprehensive FMEA up-front, when product /process can be most easily and inexpensively implemented, will alleviate late-change crises. The process is disciplined, interactive and never- ending, and many industries require FMEAs as a preventive tool.
This audio conference introduces the topic of FMEA and provides a general guidance in the application of this powerful prevention technique.
Failure Modes and Effects Analysis (FMEA) is a powerful technique designed to help the engineer improve the quality and reliability of design. When properly used, FMEA provides numerous benefits, including improved product/process reliability and quality, increased customer satisfaction, early identification and elimination of potential product/process failure modes, and prioritization of product/process deficiencies. It also facilitates capturing engineering/organization knowledge, emphasizes problem prevention, documents risk and actions taken to reduce risk, and provides focus for improved testing and development.
Applying this technique serves to identify critical parameters and support the continual improvement of products and services. Doing a comprehensive FMEA up-front, when product /process can be most easily and inexpensively implemented, will alleviate late-change crises. The process is disciplined, interactive and never- ending, and many industries require FMEAs as a preventive tool.
This audio conference introduces the topic of FMEA and provides a general guidance in the application of this powerful prevention technique.
Thursday, July 22, 2010
Adapting Project Risk Mitigation and Prevention Tools in Real-Life Trials
is being presented by Susan Schenk, Clinical Development Services, Director, Operational Strategy & Planning, with Covance Inc. and airs on Tuesday, September 21st, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Managing and preventing risk is an integral part of clinical trial conduct in order to achieve high-quality data on time and on budget. However, industry data reveals that a large percentage of clinical trial budgets is allocated towards remediation, focused on fixing problems after they occur, rather than towards proactive activities to help predict and prevent costly errors. This audio conference showcases a complementary range of real-life examples of how to leverage sophisticated tools such as Failure Modes & Effects Analysis (FMEA) to proactively manage project-related risk.
However, in the project management arena, there is often a gap between the sophisticated tools and proactive approaches available to manage project-related risk, and the general level of understanding of how to deploy these tools.
Specifically addressing this issue, the audio conference aims to help close the gap by exploring a number of different ways to leverage theory into practice. Acknowledging the need for continuous mitigation of project-related risks, the speaker also demonstrates methods to overcome challenges that may occur mid-study, successfully absorbing and minimizing the impact to timelines and resources.
Managing and preventing risk is an integral part of clinical trial conduct in order to achieve high-quality data on time and on budget. However, industry data reveals that a large percentage of clinical trial budgets is allocated towards remediation, focused on fixing problems after they occur, rather than towards proactive activities to help predict and prevent costly errors. This audio conference showcases a complementary range of real-life examples of how to leverage sophisticated tools such as Failure Modes & Effects Analysis (FMEA) to proactively manage project-related risk.
However, in the project management arena, there is often a gap between the sophisticated tools and proactive approaches available to manage project-related risk, and the general level of understanding of how to deploy these tools.
Specifically addressing this issue, the audio conference aims to help close the gap by exploring a number of different ways to leverage theory into practice. Acknowledging the need for continuous mitigation of project-related risks, the speaker also demonstrates methods to overcome challenges that may occur mid-study, successfully absorbing and minimizing the impact to timelines and resources.
Tuesday, July 20, 2010
Failure Modes & Effects Analysis (FMEA)
is being presented by Angelo Scangas, President of Quality Support Group, Inc. and airs on Tuesday, August 31st, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Failure Modes and Effects Analysis (FMEA) is a powerful technique designed to help the engineer improve the quality and reliability of design. When properly used, FMEA provides numerous benefits, including improved product/process reliability and quality, increased customer satisfaction, early identification and elimination of potential product/process failure modes, and prioritization of product/process deficiencies. It also facilitates capturing engineering/organization knowledge, emphasizes problem prevention, documents risk and actions taken to reduce risk, and provides focus for improved testing and development.
Applying this technique serves to identify critical parameters and support the continual improvement of products and services. Doing a comprehensive FMEA up-front, when product /process can be most easily and inexpensively implemented, will alleviate late-change crises. The process is disciplined, interactive and never- ending, and many industries require FMEAs as a preventive tool.
This audio conference introduces the topic of FMEA and provides a general guidance in the application of this powerful prevention technique.
Failure Modes and Effects Analysis (FMEA) is a powerful technique designed to help the engineer improve the quality and reliability of design. When properly used, FMEA provides numerous benefits, including improved product/process reliability and quality, increased customer satisfaction, early identification and elimination of potential product/process failure modes, and prioritization of product/process deficiencies. It also facilitates capturing engineering/organization knowledge, emphasizes problem prevention, documents risk and actions taken to reduce risk, and provides focus for improved testing and development.
Applying this technique serves to identify critical parameters and support the continual improvement of products and services. Doing a comprehensive FMEA up-front, when product /process can be most easily and inexpensively implemented, will alleviate late-change crises. The process is disciplined, interactive and never- ending, and many industries require FMEAs as a preventive tool.
This audio conference introduces the topic of FMEA and provides a general guidance in the application of this powerful prevention technique.
Tuesday, August 4, 2009
Optimizing Site Performance: Risk Planning vs. Remediation
A large percentage of clinical trial budgets is allocated to fix problems after they occur instead of proactive activities to predict and prevent errors. There are several factors causing the widespread variance in site performance in clinical trials, declining data quality and missed timelines. What can drug development service providers and sponsors do to proactively optimize site performance?
Protocol violations are a consequence of stressed environmental conditions at investigative sites and are extremely pervasive. Conventional measures won’t adequately detect or address them. This audio conference discusses and details how protocol violations are preventable within a risk management paradigm and outlines a process for addressing them using Failure Mode and Effect Analysis (FMEA).
Optimizing Site Performance: Risk Planning vs. Remediation was presented by Pam Atwell, Director, Operational Strategies and Planning, with Covance Clinical Development Services and aired on 2008-12-04. For more details, or to download this audio conference, please visit our site at www.fxconferences.com
Protocol violations are a consequence of stressed environmental conditions at investigative sites and are extremely pervasive. Conventional measures won’t adequately detect or address them. This audio conference discusses and details how protocol violations are preventable within a risk management paradigm and outlines a process for addressing them using Failure Mode and Effect Analysis (FMEA).
Optimizing Site Performance: Risk Planning vs. Remediation was presented by Pam Atwell, Director, Operational Strategies and Planning, with Covance Clinical Development Services and aired on 2008-12-04. For more details, or to download this audio conference, please visit our site at www.fxconferences.com
Monday, April 13, 2009
Predicting and Preventing Protocol Violations
Often, a large percentage of sponsor clinical trial budgets are allocated to remediation, focused towards fixing problems after they occur, rather than towards proactive activities which could help predict and prevent errors.
This presentation discusses clinical trial protocol violations as a consequence of stressed "environmental" conditions at investigative sites, the potential risk for patient safety and the overall impact on the success of clinical trials. The speaker examines why protocol violations are so pervasive, as well as conventional measures to handle them and their inability to adequately detect and address them. The presentation also looks at Failure Mode and Effect Analysis (FMEA) as a proactive approach to predict and prevent protocol deviations/violations. The presentation will also discuss how clinical trial protocol violations are preventable within a risk management paradigm, and will outline a process for addressing protocol violations using the FMEA approach.
Finally, the presentation addresses the implications to the sponsor's clinical trial budget of the proactive, predictive, prevention approach embodied by FMEA and how additional investment up-front can lead to improved clinical trial performance.
Predicting and Preventing Protocol Violations was presented by Dr. Brett Bishop, Executive Director Operational Strategy & Planning, with Covance and aired on 2007-06-14. This conference is available for download at www.fxconferences.com
This presentation discusses clinical trial protocol violations as a consequence of stressed "environmental" conditions at investigative sites, the potential risk for patient safety and the overall impact on the success of clinical trials. The speaker examines why protocol violations are so pervasive, as well as conventional measures to handle them and their inability to adequately detect and address them. The presentation also looks at Failure Mode and Effect Analysis (FMEA) as a proactive approach to predict and prevent protocol deviations/violations. The presentation will also discuss how clinical trial protocol violations are preventable within a risk management paradigm, and will outline a process for addressing protocol violations using the FMEA approach.
Finally, the presentation addresses the implications to the sponsor's clinical trial budget of the proactive, predictive, prevention approach embodied by FMEA and how additional investment up-front can lead to improved clinical trial performance.
Predicting and Preventing Protocol Violations was presented by Dr. Brett Bishop, Executive Director Operational Strategy & Planning, with Covance and aired on 2007-06-14. This conference is available for download at www.fxconferences.com
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