is being presented by Xavier Marchand, COO, of JBI Studios and airs on Thursday, February 24th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Corporate training departments can choose between a variety of tools to develop internal elearning courses, each with their pros and cons in terms of cost, versatility and learning curve. For those training a global workforce, the "localization-friendliness" of the tool can have serious cost implications and become an important factor in the selection process. Separately, once the tool is chosen, being able to make full use of its features and capabilities can help smooth and speed up the localization process.
In this presentation our speaker, Xavier Marchand of JBI Studios, discusses three of the most popular elearning tools – Articulate, Captivate, and Flash – examining the relative strengths and weaknesses of each from a localization perspective.
Tuesday, January 25, 2011
Monday, January 24, 2011
Understanding ISO Standards for Sustainable Economic Activity
is being presented by Federico Fische, Renewable Energy Consultant and airs on Wednesday, February 23rd, 2011. For more details or to register, please visit our site at www.fxconferences.com
While the debate on energy and climate change is in somewhat of a holding pattern in the U.S., the concept of social responsibility has gained momentum, leading to a number of ISO standards and guidelines that specifically address topics related to energy management, life cycle assessment and renewable energy.
This audio conference looks at these ISO activities, presents an overview the different paths that the electricity restructuring process in the USA has taken, the origins of that development, and the current status and performance. Most important, understanding these offerings and processing will help consumers, corporations and other organization to take a better decision with regard to energy purchasing options.
While the debate on energy and climate change is in somewhat of a holding pattern in the U.S., the concept of social responsibility has gained momentum, leading to a number of ISO standards and guidelines that specifically address topics related to energy management, life cycle assessment and renewable energy.
This audio conference looks at these ISO activities, presents an overview the different paths that the electricity restructuring process in the USA has taken, the origins of that development, and the current status and performance. Most important, understanding these offerings and processing will help consumers, corporations and other organization to take a better decision with regard to energy purchasing options.
Friday, January 21, 2011
Latino Link: Marketing to the U.S. Hispanic Population
is being presented by Isidra Mencos, Editorial Director, Americas and Spain, with BabyCenter & Joe Kutchera, Digital Director, of Acento and airs on Thursday, February 17th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Hispanics are the largest minority in the US today, accounting for nearly $1 trillion in buying power. While they represent a very large and growing audience, Hispanics are far from being a homogenous group. This audio conference focuses on the results of Johnson & Johnson's BabyCenter Acculturation study, which paints rich portraits of the diversity of the different groups and provides practical information and advice on how to effectively communicate with the unique segments that make up the U.S. Hispanic market. BabyCenter's Isidra Mencos provides insight into how Hispanic families shop for baby and children’s products, prepare family meals, and choose family healthcare products. Co-presenter and author Joe Kutchera presents research about the closing of the digital divide, and outlines how leading marketers have developed content sites to reach the Hispanic population.
Hispanics are the largest minority in the US today, accounting for nearly $1 trillion in buying power. While they represent a very large and growing audience, Hispanics are far from being a homogenous group. This audio conference focuses on the results of Johnson & Johnson's BabyCenter Acculturation study, which paints rich portraits of the diversity of the different groups and provides practical information and advice on how to effectively communicate with the unique segments that make up the U.S. Hispanic market. BabyCenter's Isidra Mencos provides insight into how Hispanic families shop for baby and children’s products, prepare family meals, and choose family healthcare products. Co-presenter and author Joe Kutchera presents research about the closing of the digital divide, and outlines how leading marketers have developed content sites to reach the Hispanic population.
Thursday, January 20, 2011
eLabeling Medical Devices for the EU Market: Issues and Advantages
is being presented by Salma Michor, CEO and Principal Consultant, of Michor Consulting EU and airs on Wednesday, February 16th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.
In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. e-labelling provides several advantages in managing regulatory compliance but also poses some challenges. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage.
Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.
In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. e-labelling provides several advantages in managing regulatory compliance but also poses some challenges. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage.
Wednesday, January 19, 2011
Managing the Medical Device Supply Chain
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Wednesday, February 16th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
Supply chains for medical devices are growing in importance as device manufacturers outsource products and services. As some of this outsourcing moves offshore and to low-cost countries, the supply chain becomes longer, more diverse, and more difficult to control. The medical device manufacturer, however, has the ultimate responsibility for the product, so supply chain management becomes a critical function.
FDA regulations for medical devices define the requirements for supplier selection, management, and control. ISO 13485 includes similar requirements. However, in February 2009, the Global Harmonization Task Force (GHTF) released a guidance document on controlling products and services from suppliers, and this guidance document has become the global de facto standard for supplier management.
This audio conference presentation helps attendees understand the regulations and the expectations of the GHTF guidance document, and how to go about implementing its provisions.
Supply chains for medical devices are growing in importance as device manufacturers outsource products and services. As some of this outsourcing moves offshore and to low-cost countries, the supply chain becomes longer, more diverse, and more difficult to control. The medical device manufacturer, however, has the ultimate responsibility for the product, so supply chain management becomes a critical function.
FDA regulations for medical devices define the requirements for supplier selection, management, and control. ISO 13485 includes similar requirements. However, in February 2009, the Global Harmonization Task Force (GHTF) released a guidance document on controlling products and services from suppliers, and this guidance document has become the global de facto standard for supplier management.
This audio conference presentation helps attendees understand the regulations and the expectations of the GHTF guidance document, and how to go about implementing its provisions.
Monday, January 17, 2011
FDA Guidance on Clinical Investigator Roles and Responsibilities
is being presented by Dr. Anita S. Kablinger, Virginia Tech Carilion School of Medicine and airs on February 15th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Clinical researchers face a steep learning curve. The importance of research, as well as the practice of participation in research, remains a relatively minor component of medical school and graduate medical education. Clinical investigators often have limited knowledge of the FDA rules and regulations in drug development other aspects of clinical research.
This presentation reviews the FDA guidance concerning what the clinical investigator – as well as those seeking qualified investigators – needs to know and demonstrate to provide academic rigor, maintain the highest safety standards of participants and promote the development of novel compounds and devices.
Clinical researchers face a steep learning curve. The importance of research, as well as the practice of participation in research, remains a relatively minor component of medical school and graduate medical education. Clinical investigators often have limited knowledge of the FDA rules and regulations in drug development other aspects of clinical research.
This presentation reviews the FDA guidance concerning what the clinical investigator – as well as those seeking qualified investigators – needs to know and demonstrate to provide academic rigor, maintain the highest safety standards of participants and promote the development of novel compounds and devices.
Friday, January 14, 2011
Preventing Harassment in the Workplace
is being presented by Marna Hayden, President, of Hayden Resources Inc. and airs on Tuesday, February 1st, 2011. For more details or to register, please visit our site at www.fxconferences.com
There is no room for any kind of harassment in the workplace today, and employers have both a moral and legal responsibility to shield employees from this intimidating behaviour. This audio conference presentation focuses on what is considered harassment and sexual harassment, reviewing the laws that protect employees from harassment and the recourses they have. The speaker looks at who is covered and discusses the two main kinds of sexual harassment in the workplace. The presentation includes sample policies and programs that work to prevent and address any situation that may be construed as harassment. It also covers the proper way to document events, investigations, and outcomes of incidents, as well as the tangible benefits of a harassment-free environment at work.
There is no room for any kind of harassment in the workplace today, and employers have both a moral and legal responsibility to shield employees from this intimidating behaviour. This audio conference presentation focuses on what is considered harassment and sexual harassment, reviewing the laws that protect employees from harassment and the recourses they have. The speaker looks at who is covered and discusses the two main kinds of sexual harassment in the workplace. The presentation includes sample policies and programs that work to prevent and address any situation that may be construed as harassment. It also covers the proper way to document events, investigations, and outcomes of incidents, as well as the tangible benefits of a harassment-free environment at work.
Thursday, January 13, 2011
Generating Risk-Based Design Input Early in the Design Process
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.
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.
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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