is being presented by Bernard Bosley, Risk Management Consultant, of Koumu Engineering, Inc. and airs on Thursday, February 10th, 2011. For more details or to register please visit our site at www.fxconferences.com
Effective risk management requires analysis before the device is designed. This is essential for risk-based design input, and if it is not done early, then the risk information has little impact on the design. However, although it is required, the international standard for risk management (ISO 14971) gives very little guidance in this area.
This audio conference presentation shows how to accomplish risk-based design input early in the design process. It is intended for people who already have a basic understanding of risk management but are interested in ways to improve effectiveness in some of the more difficult and challenging areas of risk analysis.
Thursday, January 13, 2011
Monday, January 10, 2011
Influencing Internal Clients
is being presented by Herb Cohen, Senior Managing Partner, Performance Connections International, Inc and airs on Thursday, January 27th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Successful technical professionals realize the importance of developing ongoing and productive “win-win” relationships with others inside their companies. Influencing and negotiating with coworkers in different areas of the company to gain their time and commitment to meet your needs is critical to your personal success as well as that of your business. This is especially true when resources are stretched.
Many people find it daunting when faced with a need to influence others, but the uniqueness of technical professional’s training and experience gives them additional layers of challenges and issues. While you and your coworkers all support the greater needs of the company, understanding each other’s individual and departmental issues is important in getting results. This isn’t always simple to do, and, in fact, can become even more complicated when you must make your case to a group, rather than to an individual.
Successful technical professionals realize the importance of developing ongoing and productive “win-win” relationships with others inside their companies. Influencing and negotiating with coworkers in different areas of the company to gain their time and commitment to meet your needs is critical to your personal success as well as that of your business. This is especially true when resources are stretched.
Many people find it daunting when faced with a need to influence others, but the uniqueness of technical professional’s training and experience gives them additional layers of challenges and issues. While you and your coworkers all support the greater needs of the company, understanding each other’s individual and departmental issues is important in getting results. This isn’t always simple to do, and, in fact, can become even more complicated when you must make your case to a group, rather than to an individual.
Friday, January 7, 2011
Keep Pace with Industry: Updating Training Content Dynamically
is being presented by David Glow, Chief Learning Architect and airs on Wednesday, January 26th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
Every organization is responsible for deploying and maintaining training in a timely manner to keep pace with industry Employees require support and information to perform, especially during times of rapid change. This is paramount in businesses operating in highly regulated environments such as healthcare and financial services, where changes are not only rapid, but compliance is mandatory.
Many companies struggle in deploying new training resources or updating existing resources in a timely manner. Most organizations use a development model that is not efficient, and often duplicates efforts. Common development models delay deployment time which leaves the workforce under prepared on required skills.
This audio conference provides several practical approaches for organizations to employ a training system design to dynamically update content to keep pace with necessary business and industry changes.
Every organization is responsible for deploying and maintaining training in a timely manner to keep pace with industry Employees require support and information to perform, especially during times of rapid change. This is paramount in businesses operating in highly regulated environments such as healthcare and financial services, where changes are not only rapid, but compliance is mandatory.
Many companies struggle in deploying new training resources or updating existing resources in a timely manner. Most organizations use a development model that is not efficient, and often duplicates efforts. Common development models delay deployment time which leaves the workforce under prepared on required skills.
This audio conference provides several practical approaches for organizations to employ a training system design to dynamically update content to keep pace with necessary business and industry changes.
Thursday, January 6, 2011
Risk Management for Medical Devices
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Wednesday, January 26th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Risk Management is vital in medical device design, manufacturing, and post-market surveillance. The FDA QSR requires risk analysis in the design phase, but realizes the need for life cycle management through the complaint system. The FDA recognizes ISO 14971:2007 as a consensus standard. In the European Union, EN ISO 14971:2007 is a harmonized standard and notified bodies will expect full compliance. ISO 13485:2003 also calls out the standard as preferred method.
This audio conference introduces the concepts of Risk Management in ISO 14971:2007. It explains the flow of information from the Risk Management Plan to the Risk Management Report. It covers the differences among Hazard, Harm, and Risk and explains how to evaluate each of them. The program describes development of a Risk Evaluation Matrix taking into account the probability of occurrence and the severity of the harm. The standard requires a list of known and foreseeable hazards as well as foreseeable sequences of events that could result in harm. The presentation describes the tools (FMEA, FTA, and HAACP) and their application.
Risk Management is vital in medical device design, manufacturing, and post-market surveillance. The FDA QSR requires risk analysis in the design phase, but realizes the need for life cycle management through the complaint system. The FDA recognizes ISO 14971:2007 as a consensus standard. In the European Union, EN ISO 14971:2007 is a harmonized standard and notified bodies will expect full compliance. ISO 13485:2003 also calls out the standard as preferred method.
This audio conference introduces the concepts of Risk Management in ISO 14971:2007. It explains the flow of information from the Risk Management Plan to the Risk Management Report. It covers the differences among Hazard, Harm, and Risk and explains how to evaluate each of them. The program describes development of a Risk Evaluation Matrix taking into account the probability of occurrence and the severity of the harm. The standard requires a list of known and foreseeable hazards as well as foreseeable sequences of events that could result in harm. The presentation describes the tools (FMEA, FTA, and HAACP) and their application.
Tuesday, January 4, 2011
Industry Update on Centralized Procedure in the EU
is being presented by Dr. Ulrich Granzer, Granzer Regulatory Consulting and airs on Thursday, January 20th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
The revised EU pharma legislation has seen some major changes since coming into force, changes that have now been implemented and, more importantly, interpreted. New and additional guidelines have been issued, a system of scientific advisory groups (SAG) has been established, and the procedure to obtain a marketing authorization is being performed in a more stringent way.
In this audio conference we discuss how centralised procedure works, important points to consider, and how the paediatric regulation has created the necessity for a more extensive planning process – and in particular, how line extensions of existing products are concerned.
The revised EU pharma legislation has seen some major changes since coming into force, changes that have now been implemented and, more importantly, interpreted. New and additional guidelines have been issued, a system of scientific advisory groups (SAG) has been established, and the procedure to obtain a marketing authorization is being performed in a more stringent way.
In this audio conference we discuss how centralised procedure works, important points to consider, and how the paediatric regulation has created the necessity for a more extensive planning process – and in particular, how line extensions of existing products are concerned.
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