is being presented by Steven Walfish, Statistician, with GE Healthcare and airs on Wednesday, April 4th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process for medical devices to ensure that the completed design that is transferred to production is appropriate for its intended use. The goal of this presentation is to understand the requirements and statistical techniques involved in the design controls process.
This audio conference looks at the types of requirements that lend themselves to statistics in verification and validation. Our speaker also covers the relationship between risk and sample size. Participants gain a fundamental knowledge for determining sample size in statistical testing, while understanding how variance in the population can impact the sample size necessary to establish objective evidence.
Showing posts with label Steven Walfish. Show all posts
Showing posts with label Steven Walfish. Show all posts
Friday, March 30, 2012
Monday, September 19, 2011
Sample Size for Design Verification and Validation
is being presented by Steven Walfish, Statistician, with GE Healthcare and airs on Thursday, October 20th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process for medical devices to ensure that the completed design that is transferred to production is appropriate for its intended use. The goal of this presentation is to understand the requirements and statistical techniques involved in the design controls process.
This audio conference looks at the types of requirements that lend themselves to statistics in verification and validation. Our speaker also covers the relationship between risk and sample size. Participants gain a fundamental knowledge for determining sample size in statistical testing, while understanding how variance in the population can impact the sample size necessary to establish objective evidence.
Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process for medical devices to ensure that the completed design that is transferred to production is appropriate for its intended use. The goal of this presentation is to understand the requirements and statistical techniques involved in the design controls process.
This audio conference looks at the types of requirements that lend themselves to statistics in verification and validation. Our speaker also covers the relationship between risk and sample size. Participants gain a fundamental knowledge for determining sample size in statistical testing, while understanding how variance in the population can impact the sample size necessary to establish objective evidence.
Thursday, February 24, 2011
Using Statistics to Minimize Risk
is being presented by Steven Walfish, Statistician, with GE Healthcare and airs on Wednesday, March 30th, 2011. For more details or to register, please visit our site at www.fxconferences.com
A good risk management process helps to minimize unforeseen issues after product launch. Part of a good risk management process is the use of sound data analysis procedures including data collection.
This audio conference provides attendees with an excellent overview of statistical techniques and risk management. The presentation looks at the difference between statistical risk and product risk, and reviews how to go about calculating a risk index. Our speaker also discusses methods of using statistical data to identify existing and potential causes of nonconforming product, estimating defect rates, and how best to incorporate risk management in your CAPA process.
A good risk management process helps to minimize unforeseen issues after product launch. Part of a good risk management process is the use of sound data analysis procedures including data collection.
This audio conference provides attendees with an excellent overview of statistical techniques and risk management. The presentation looks at the difference between statistical risk and product risk, and reviews how to go about calculating a risk index. Our speaker also discusses methods of using statistical data to identify existing and potential causes of nonconforming product, estimating defect rates, and how best to incorporate risk management in your CAPA process.
Monday, November 15, 2010
Quality Monitoring and Reporting with Statistical Trending Analysis
is being presented by Steven Walfish, Statistician, with GE Healthcare and airs on Wednesday, December 8th, 2010. For more details or to register, please visit our site at www.fxconferences.com
There are several methods to trend data to highlight both the preventative and corrective nature of the system. Plotting data over time is a good visual method to identify trends. Statistical Process Control (SPC) techniques such as control charts give an objective method to identify trends. The intention of trending is two-fold, first it is to identify before the system goes out of control the potential for problems. Secondly, it helps to show improvement after a change to the system. Trending analysis can be applied to complaints, process data, nonconformances, CAPA and other quality system data.
Participants in this audio conference gain an increase in their awareness of how trending analysis can be used to report systematic data to management. Beyond graphical methods, the presentation covers statistical methods such as weighted moving averages and low occurrence trending.
There are several methods to trend data to highlight both the preventative and corrective nature of the system. Plotting data over time is a good visual method to identify trends. Statistical Process Control (SPC) techniques such as control charts give an objective method to identify trends. The intention of trending is two-fold, first it is to identify before the system goes out of control the potential for problems. Secondly, it helps to show improvement after a change to the system. Trending analysis can be applied to complaints, process data, nonconformances, CAPA and other quality system data.
Participants in this audio conference gain an increase in their awareness of how trending analysis can be used to report systematic data to management. Beyond graphical methods, the presentation covers statistical methods such as weighted moving averages and low occurrence trending.
Tuesday, June 15, 2010
Using Practical Statistics to Interpret Stability Results
is being presented by Steven Walfish, President, of Statistical Outsourcing Services and airs on Wednesday, July 21st, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
The ICH Q1 is not prescriptive on which statistics are most appropriate for reporting stability data. More importantly, using the incorrect statistics can lead to incorrect conclusions.
In this audio conference, our speaker reviews the statistical concepts used in stability analysis, using an overview of the ICH Q1 guidance as the framework for discussion. The presentation looks at linear models as the statistical tool used for stability analysis, but also covers methods for dealing with data that does fit the linear model. Typically, regression analysis is used to assess stability, and in this audio conference the speaker highlights the assumptions and risks of regression. Finally, the presentation draws on real-life examples to discuss the covariance model for determining poolability of the lots.
The ICH Q1 is not prescriptive on which statistics are most appropriate for reporting stability data. More importantly, using the incorrect statistics can lead to incorrect conclusions.
In this audio conference, our speaker reviews the statistical concepts used in stability analysis, using an overview of the ICH Q1 guidance as the framework for discussion. The presentation looks at linear models as the statistical tool used for stability analysis, but also covers methods for dealing with data that does fit the linear model. Typically, regression analysis is used to assess stability, and in this audio conference the speaker highlights the assumptions and risks of regression. Finally, the presentation draws on real-life examples to discuss the covariance model for determining poolability of the lots.
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