is being presented by Maria Shepherd, Principal, with Data Decision Group and airs on Thursday, December 16th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Medical device manufacturers are required by FDA and other global regulatory bodies to demonstrate how human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user, how the device will be used, the environment in which it will be used, and existing use-related hazards.
This audio conference presentation is designed for those new to the integration of human factors research into product design, or those who want a basic overview of FDA requirements in this area. This presentation reviews several guidance documents issued by FDA regarding its human factors initiative, and the speaker also discusses the various types of usability testing routinely used in the medical device industry, including qualitative and quantitative assessments.
Wednesday, November 17, 2010
Tuesday, November 16, 2010
Risk-Based CAPA - New Guidelines and Expectations
is being presented by Vinny Sastri, President, of Winovia LLC and airs on Tuesday, December 14th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Why does a significant percentage of all warning letters for medical devices and pharmaceuticals continue to be CAPA-related even though critical thinking and problem solving methodologies proliferate in the industry? In November 2009, the Global Harmonization Task Force (GHTF) issued a draft, proposed guidance document that provides the latest thinking and approach of the regulatory bodies on CAPA. This includes the use of risk-based processes and decisions.
This audio conference discusses how to use risk-based decisions in implementing, prioritizing and conducting CAPA projects and processes. In addition it provides organizational best practices to enable effective CAPA systems.
Why does a significant percentage of all warning letters for medical devices and pharmaceuticals continue to be CAPA-related even though critical thinking and problem solving methodologies proliferate in the industry? In November 2009, the Global Harmonization Task Force (GHTF) issued a draft, proposed guidance document that provides the latest thinking and approach of the regulatory bodies on CAPA. This includes the use of risk-based processes and decisions.
This audio conference discusses how to use risk-based decisions in implementing, prioritizing and conducting CAPA projects and processes. In addition it provides organizational best practices to enable effective CAPA systems.
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.
Monday, November 8, 2010
Preparing for FDA GCP Inspections – Essentials for Sponsors and Clinical Sites
is being presented by Kimberly Kiner, President, of 2K Clinical Consulting and airs on Thursday, December 9th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
GCP inspections, particularly those involving FDA investigators, are often seen as an intimidating and adversarial experience, as opposed to a useful process for improving quality and ensuring compliance. However, there are steps you can take to make the process less stressful, and to avoid the most common issues arising during these inspections.
In this audio conference, our speaker, a former FDA investigator, shares insight on how FDA prepares for an inspection, and reviews GCP regulations and FDA guidelines used for inspections. The presentation provides attendees from sponsor companies (pharmaceutical, biotech, device/diagnostics) and clinical sites with practical information on how to utilize quality improvement methods to effectively prepare for FDA GCP inspections.
GCP inspections, particularly those involving FDA investigators, are often seen as an intimidating and adversarial experience, as opposed to a useful process for improving quality and ensuring compliance. However, there are steps you can take to make the process less stressful, and to avoid the most common issues arising during these inspections.
In this audio conference, our speaker, a former FDA investigator, shares insight on how FDA prepares for an inspection, and reviews GCP regulations and FDA guidelines used for inspections. The presentation provides attendees from sponsor companies (pharmaceutical, biotech, device/diagnostics) and clinical sites with practical information on how to utilize quality improvement methods to effectively prepare for FDA GCP inspections.
Thursday, November 4, 2010
Complying with Employment Law When Interviewing & Hiring
is being presented by Marna Hayden, Founder and President, of Hayden Resources Inc. and airs on Thursday, December 2nd, 2010. For more details or to register, please visit our site at www.fxconferences.com
Hiring the right people is one of the most important jobs any human resources professional or manager does. From the entrance level recruiter to the seasoned professional in charge of executive hiring, this audio conference provides practical pointers on hiring best practices and pitfalls.
The presentation covers the interviewing and selection process from the perspective of compliance to applicable employment laws, and reviews each step. It covers what is allowed, what may be discriminatory, and what specific questions should not be asked in an employment interview. Our speaker also discusses how best to evaluate a candidate, how to measure what constitutes adverse impact in hiring, and how to legally conduct reference and background checks.
Hiring the right people is one of the most important jobs any human resources professional or manager does. From the entrance level recruiter to the seasoned professional in charge of executive hiring, this audio conference provides practical pointers on hiring best practices and pitfalls.
The presentation covers the interviewing and selection process from the perspective of compliance to applicable employment laws, and reviews each step. It covers what is allowed, what may be discriminatory, and what specific questions should not be asked in an employment interview. Our speaker also discusses how best to evaluate a candidate, how to measure what constitutes adverse impact in hiring, and how to legally conduct reference and background checks.
Tuesday, November 2, 2010
Using Standards for Attribute Sampling
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Wednesday, December 1st, 2010. For more details or to register, please visit our site at www.fxconferences.com
This audio conference presentation helps attendees understand and implement acceptance sampling, explaining the basis for sampling plans, the binomial distribution, and showing how it helps us understand sampling plan performance using the operating characteristic (OC) curve. Participants gain a solid understanding of the risks involved in sampling by understanding the OC. Our speaker shows how the shape of curve describes risk, and identifies some of the most important points on the curve (AQL and RQL points).
The audio conference provides complete descriptions of three other important curves that help you understand a sampling plan: the average sample number (ASN), average outgoing quality (AOQ), and average total inspected (ATI).
The presentation provides a complete description of Z1.4, showing the process from receiving the lot to selecting the sample size to making the accept/reject decision. The speaker also examines c=0 plans using the curves described above. The OC curve, in these plans, has a different shape that can lead to problems. The presentation looks at some issues with converting from Z1.4 to c=0 plans, especially related to inventory levels and supplier evaluation.
This audio conference presentation helps attendees understand and implement acceptance sampling, explaining the basis for sampling plans, the binomial distribution, and showing how it helps us understand sampling plan performance using the operating characteristic (OC) curve. Participants gain a solid understanding of the risks involved in sampling by understanding the OC. Our speaker shows how the shape of curve describes risk, and identifies some of the most important points on the curve (AQL and RQL points).
The audio conference provides complete descriptions of three other important curves that help you understand a sampling plan: the average sample number (ASN), average outgoing quality (AOQ), and average total inspected (ATI).
The presentation provides a complete description of Z1.4, showing the process from receiving the lot to selecting the sample size to making the accept/reject decision. The speaker also examines c=0 plans using the curves described above. The OC curve, in these plans, has a different shape that can lead to problems. The presentation looks at some issues with converting from Z1.4 to c=0 plans, especially related to inventory levels and supplier evaluation.
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