is being presented by Ira G. Asherman, President, of Asherman Associates, Inc. and airs on Wednesday, April 6th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Negotiating is an essential skill for most job functions, one we use almost every day in the workplace. The success or failure of a project can hinge on how well one negotiates, either with co-workers and internal clients or with external parties such as vendors, partners or government bodies. These give-and-take skills have become even more important in this age of out-sourcing, joint ventures and mergers, all of which increase the pressure on employees to effectively represent themselves and their companies in negotiations.
This audio conference presentation explores the critical skills of the successful negotiator, providing insight into what makes some more successful than others at negotiating, and the steps you can take to make yourself a more powerful force at the bargaining table. The speaker also touches on the impact of factors like language and culture on negotiation, and why trust is paramount to successful negotiation.
Monday, February 28, 2011
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.
Wednesday, February 23, 2011
The FDA’s New Emphasis on Supplier Controls – What Device Manufacturers Need to Know
is being presented by Vinny Sastri, President, of Winovia LLC and airs on Tuesday, March 22nd, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
The FDA will be putting a lot more emphasis on purchasing controls and supplier selection and audit requirements for medical device manufacturers. In December of 2008 the Global Harmonization Task Force issued a guidance document on “the Controls of Products and Services Obtained from Suppliers” detailing the requirements and expectations manufacturers must meet to exert more control over their suppliers.
This audio conference presentation reviews those expectations and the details of the new guidance document, and also discusses how these new requirements affect medical device manufacturers. Our speaker also looks at how design and development, risk management and process controls are intricately linked to purchasing controls.
The FDA will be putting a lot more emphasis on purchasing controls and supplier selection and audit requirements for medical device manufacturers. In December of 2008 the Global Harmonization Task Force issued a guidance document on “the Controls of Products and Services Obtained from Suppliers” detailing the requirements and expectations manufacturers must meet to exert more control over their suppliers.
This audio conference presentation reviews those expectations and the details of the new guidance document, and also discusses how these new requirements affect medical device manufacturers. Our speaker also looks at how design and development, risk management and process controls are intricately linked to purchasing controls.
Tuesday, February 22, 2011
Through Challenging Times to Improved Performance
is being presented by Sherry Bright, VP, Clinical & Performance Improvement, with VHA Mountain States and airs on Wednesday, March 23rd, 2011. For more details or to register, please visit our site at www.fxconferences.com
Catalyzed by health care reform, driven by the pressing need to significantly bend the cost curve, the health care delivery system is transforming itself. Suppliers to providers will need to remake themselves, as well, to be chosen as the highest value provider of services, materials and devices.
This presentation describes a systemic approach to organizational improvement that has been proven to result in increased market share, stronger customer relationships and, ultimately, higher profitability. Using examples from leading manufacturing and small business performers, the presenter examines strategies already in place that have assured strong line-of-sight between leadership and customer. The presentation addresses how organizations can assess their own strategies and begin to build more effective models that will support gains in customer share.
Catalyzed by health care reform, driven by the pressing need to significantly bend the cost curve, the health care delivery system is transforming itself. Suppliers to providers will need to remake themselves, as well, to be chosen as the highest value provider of services, materials and devices.
This presentation describes a systemic approach to organizational improvement that has been proven to result in increased market share, stronger customer relationships and, ultimately, higher profitability. Using examples from leading manufacturing and small business performers, the presenter examines strategies already in place that have assured strong line-of-sight between leadership and customer. The presentation addresses how organizations can assess their own strategies and begin to build more effective models that will support gains in customer share.
Monday, February 21, 2011
Best Practices for Preparing Clinical Evaluation Reports
is being presented by Phil Triolo, President, of Phil Triolo and Associates LC and airs on Tuesday, March 22nd, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
Clinical Evaluation Reports (CERs) document the assessment and analysis of clinical data (literature, results of clinical investigations, complaints) and preclinical data to establish conformity of a medical device with the pertinent requirements of the Medical Devices Directive.
Recent publication of ISO 14155:2011 introduces new requirements that supplement the requirements and recommendations for CERs that appear in MEDDEV 2.7.1 Rev 3 and GHTF document SG5/N2R8:2007.
This audio conference presentation outlines these new requirements and provides helpful hints and examples of how to meet, efficiently and effectively, new and existing CER requirements.
Clinical Evaluation Reports (CERs) document the assessment and analysis of clinical data (literature, results of clinical investigations, complaints) and preclinical data to establish conformity of a medical device with the pertinent requirements of the Medical Devices Directive.
Recent publication of ISO 14155:2011 introduces new requirements that supplement the requirements and recommendations for CERs that appear in MEDDEV 2.7.1 Rev 3 and GHTF document SG5/N2R8:2007.
This audio conference presentation outlines these new requirements and provides helpful hints and examples of how to meet, efficiently and effectively, new and existing CER requirements.
Friday, February 18, 2011
Risk Management Throughout the Medical Device Product Lifecycle
is being presented by Bill White, Senior Consultant, with Quality System Strategies LLC and airs on Thursday, March 17th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Management of product risk is not addressed prominently either in the FDA’s Quality System Registration or in ISO 13485:2003. Nevertheless, in order to ensure the well being of customers and the company itself, each medical device company must incorporate product risk management concepts throughout its quality management system. The Global Harmonization Task Force issued a guidance document which provides an excellent starting point in identifying the processes that need to include risk management. However, going beyond the guidance document calls attention to both opportunities and pitfalls in product risk management.
This audio conference reviews senior management responsibilities and benefits related to product risk management. The speaker identifies the risk management principles to be incorporated throughout the quality management system, with particular emphasis on links between processes.
Management of product risk is not addressed prominently either in the FDA’s Quality System Registration or in ISO 13485:2003. Nevertheless, in order to ensure the well being of customers and the company itself, each medical device company must incorporate product risk management concepts throughout its quality management system. The Global Harmonization Task Force issued a guidance document which provides an excellent starting point in identifying the processes that need to include risk management. However, going beyond the guidance document calls attention to both opportunities and pitfalls in product risk management.
This audio conference reviews senior management responsibilities and benefits related to product risk management. The speaker identifies the risk management principles to be incorporated throughout the quality management system, with particular emphasis on links between processes.
Wednesday, February 16, 2011
Drivers and Risks of Off-shoring Clinical Data Management
is being presented by Dr. Johann Proeve, Head of Global Data Management, with Bayer Healthcare and airs on Thursday, March 24th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Off-shoring of certain activities related to the management of clinical trials has become commonplace in the pharmaceutical and biotechnology industry, and one of the functions most affected has been clinical data management (CDM). The main contributors for off-shoring CDM are the fixed costs, lower salaries in low-cost countries and CDM being viewed as a non-core competency in the industry.
But is off-shoring really the easy solution it might appear to be when faced with the rising cost of conducting clinical research? Certainly, off-shoring of CDM is associated with certain risks, including high staff turnover, required overhead for the management of the processes, availability of knowledgeable staff for health authority inspections and the eventual erosion of the cost advantage compared to Western countries.
This audio conference addresses the main drivers and risks associated with the off-shoring of CDM, and looks at the various ways in which CDM can contribute and thereby justify its existence.
Off-shoring of certain activities related to the management of clinical trials has become commonplace in the pharmaceutical and biotechnology industry, and one of the functions most affected has been clinical data management (CDM). The main contributors for off-shoring CDM are the fixed costs, lower salaries in low-cost countries and CDM being viewed as a non-core competency in the industry.
But is off-shoring really the easy solution it might appear to be when faced with the rising cost of conducting clinical research? Certainly, off-shoring of CDM is associated with certain risks, including high staff turnover, required overhead for the management of the processes, availability of knowledgeable staff for health authority inspections and the eventual erosion of the cost advantage compared to Western countries.
This audio conference addresses the main drivers and risks associated with the off-shoring of CDM, and looks at the various ways in which CDM can contribute and thereby justify its existence.
Monday, February 14, 2011
Beyond Using SharePoint to Manage Regulatory Documents
is being presented by John Postle & Kent Fernald, Vice President, Life Sciences & Development Manager/CTO, of Court Square Group and airs on Wednesday, March 16th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
Pharmaceutical and biotech companies have been facing increasing demands to improve their organizational effectiveness through information sharing and collaboration. At the same time, there is an important need for a controlled document management system that is compliant with FDA regulations. In this conference, our speakers not only look at the steps that have been successful for designing, configuring, and implementing Microsoft SharePoint within the confines of a regulated environment, but also review organizational collaboration features (wikis and blogs) and document workflows that organizations are using.
Speakers John Postle and Kent Fernald explain how to achieve ongoing compliance through the use of SharePoint as a validated application in a qualified environment. They also present real-life examples of several regulatory compliant business applications that have been developed using the SharePoint platform.
Pharmaceutical and biotech companies have been facing increasing demands to improve their organizational effectiveness through information sharing and collaboration. At the same time, there is an important need for a controlled document management system that is compliant with FDA regulations. In this conference, our speakers not only look at the steps that have been successful for designing, configuring, and implementing Microsoft SharePoint within the confines of a regulated environment, but also review organizational collaboration features (wikis and blogs) and document workflows that organizations are using.
Speakers John Postle and Kent Fernald explain how to achieve ongoing compliance through the use of SharePoint as a validated application in a qualified environment. They also present real-life examples of several regulatory compliant business applications that have been developed using the SharePoint platform.
Friday, February 11, 2011
Essential Elements of a Food Safety Liability Program
is being presented by Thomas Packer, Partner, with Gordon & Rees LLP and airs on Tuesday, March 15th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
One need look no further than the headlines to see the consequences of a lapse in food safety measures. Even minor incidents can lead to litigation, a tarnished corporate image, and diminished consumer confidence. More serious incidents that result in illness or death can destroy a brand altogether. So how does a company go about maximizing safety while minimizing the potential damage in the event of a mishap?
In this audio conference, attorney Thomas Packer discuss the essential elements that must be present in a food safety liability program, and provides insight and guidance on how to implementing a successful program in your company. The presentation focuses on how to prepare for food liability issues, and how best to respond and then resolve them effectively and efficiently.
One need look no further than the headlines to see the consequences of a lapse in food safety measures. Even minor incidents can lead to litigation, a tarnished corporate image, and diminished consumer confidence. More serious incidents that result in illness or death can destroy a brand altogether. So how does a company go about maximizing safety while minimizing the potential damage in the event of a mishap?
In this audio conference, attorney Thomas Packer discuss the essential elements that must be present in a food safety liability program, and provides insight and guidance on how to implementing a successful program in your company. The presentation focuses on how to prepare for food liability issues, and how best to respond and then resolve them effectively and efficiently.
Wednesday, February 9, 2011
Correction and CAPA: What's the Difference?
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Thursday, March 10th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
Do you know the difference between corrective action and preventive action? The difference between them is confusing because many practitioners don’t realize these terms have specific meaning in the quality profession. These two terms probably create more misunderstanding for quality professionals than any other pair of words.
There are two reasons for this problem. First, people tend to apply colloquial language without realizing they are defined technical terms. Second, corrective action prevents the recurrence of a problem, so the language leads us, incorrectly, to call it preventive action. With the term “correction”, the confusion can become a morass.
These two terms have clear meaning in a Quality Management System, and the formal definitions highlight the difference. This presentation uses the definitions found in ISO 9000:2005 to help attendees understand the terms, and illustrates the differences with examples that clarify each term.
Do you know the difference between corrective action and preventive action? The difference between them is confusing because many practitioners don’t realize these terms have specific meaning in the quality profession. These two terms probably create more misunderstanding for quality professionals than any other pair of words.
There are two reasons for this problem. First, people tend to apply colloquial language without realizing they are defined technical terms. Second, corrective action prevents the recurrence of a problem, so the language leads us, incorrectly, to call it preventive action. With the term “correction”, the confusion can become a morass.
These two terms have clear meaning in a Quality Management System, and the formal definitions highlight the difference. This presentation uses the definitions found in ISO 9000:2005 to help attendees understand the terms, and illustrates the differences with examples that clarify each term.
Tuesday, February 8, 2011
Safety Reporting for Clinical Trials
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Wednesday, March 9th, 2011. For more details or to register, please visit our site at www.fxconferences.com
This audio conference provides an overview of the rules for expedited and periodic safety reporting for clinical trials of drugs and medical devices in the EU and USA. It is relatively easy to be compliant in the harmonized world of pharmaceutical clinical trials. However, this contrasts with the disparate requirements for medical device studies.
In this presentation, our speaker reviews the regulations and guidance and explains what needs to be reported to the regulatory authority and ethics committee or IRB, and when. The presentation also explains the procedures that need to be in place to ensure compliance for safety reporting in complex situations such as trials that span different regions, or trials of products that are regulated differently in different territories. Other "hot button" topics are addressed as well. Attendees learn what needs to be reported when, and how to set up procedures that ensure compliance with safety reporting requirements, whether the clinical trial is a simple one or more complicated.
This audio conference provides an overview of the rules for expedited and periodic safety reporting for clinical trials of drugs and medical devices in the EU and USA. It is relatively easy to be compliant in the harmonized world of pharmaceutical clinical trials. However, this contrasts with the disparate requirements for medical device studies.
In this presentation, our speaker reviews the regulations and guidance and explains what needs to be reported to the regulatory authority and ethics committee or IRB, and when. The presentation also explains the procedures that need to be in place to ensure compliance for safety reporting in complex situations such as trials that span different regions, or trials of products that are regulated differently in different territories. Other "hot button" topics are addressed as well. Attendees learn what needs to be reported when, and how to set up procedures that ensure compliance with safety reporting requirements, whether the clinical trial is a simple one or more complicated.
Monday, February 7, 2011
Hydrophilic Coating Options for Medical Devices
is being presented by Josh Simon, Senior Product Manager, Coating Technologies, with Biocoat, Inc. and airs on Wednesday, March 2nd, 2011. For more details or to register, please visit our site at www.fxconferences.com
Hydrophilic materials attract water, and when used in medical device coatings, improve lubrication. This can be beneficial with products like catheters and wound dressings. However, not all coatings are created equal, nor are they appropriate in all cases. This audio conference provides an overview of hydrophilic coatings for medical devices, how they work, and when they should and should not be used. Our speaker provides attendees with valuable insight regarding the questions that should be asked when evaluating prospective vendors and coating options related to specific devices and applications.
Hydrophilic materials attract water, and when used in medical device coatings, improve lubrication. This can be beneficial with products like catheters and wound dressings. However, not all coatings are created equal, nor are they appropriate in all cases. This audio conference provides an overview of hydrophilic coatings for medical devices, how they work, and when they should and should not be used. Our speaker provides attendees with valuable insight regarding the questions that should be asked when evaluating prospective vendors and coating options related to specific devices and applications.
Friday, February 4, 2011
Understanding Clinical Data Management Standards
is being presented by Jonathan Andrus & Jennifer Price, Vice President, Data Management and Quality & Director, Clinical Solutions, of BioClinica and airs on Tuesday, March 8th, 2011. For more details or to register, please visit our site at www.fxconferences.com
In 2010 the FDA released its draft standards plan ‘CDER Data Standards Plan Version 1.0’ which outlines key objectives for a data standards program at CDER. The use of standards in clinical research is evolving and gaining widespread acceptance. This presentation reviews the standards listed in the FDA’s draft plan, along with others relevant to clinical research.
Standards can be used from the beginning of the clinical research process starting with protocol design, moving to data collection, data analysis, and data submission. Standards are also used by disparate systems for the exchange of data. By using standards, your company can design standard data collection and reporting structures and libraries. When using standard libraries, functions such as training and programming can be streamlined to increase efficiencies and reduce rework.
This presentation provides attendees with a general understanding of the current and emerging standards being used today in our industry – including PRM, CDASH, SDTM, ODM, AdAM, LAB, CDISC Terminology, eCTD, HL7, RFD and BRIDG – and how each standard relates to specific job functions.
In 2010 the FDA released its draft standards plan ‘CDER Data Standards Plan Version 1.0’ which outlines key objectives for a data standards program at CDER. The use of standards in clinical research is evolving and gaining widespread acceptance. This presentation reviews the standards listed in the FDA’s draft plan, along with others relevant to clinical research.
Standards can be used from the beginning of the clinical research process starting with protocol design, moving to data collection, data analysis, and data submission. Standards are also used by disparate systems for the exchange of data. By using standards, your company can design standard data collection and reporting structures and libraries. When using standard libraries, functions such as training and programming can be streamlined to increase efficiencies and reduce rework.
This presentation provides attendees with a general understanding of the current and emerging standards being used today in our industry – including PRM, CDASH, SDTM, ODM, AdAM, LAB, CDISC Terminology, eCTD, HL7, RFD and BRIDG – and how each standard relates to specific job functions.
Thursday, February 3, 2011
Implications of the Electro-medical Standards IEC 60601-1-11:2010 & Proposed IEC 60601-1-12
is being presented by Leo Eisner, Product Safety & Regulatory Consultant, of Eisner Safety Consultants and airs on Thursday, March 3rd, 2011. For more details or to register, please visit our site at www.fxconferences.com
Get up to speed on the latest and developing requirements for the electro-medical collateral standards for the home healthcare environment (HHE) IEC 60601-1-11:2010 and the proposed IEC 60601-1-12 standard for the emergency medical environment (EMS). These two collateral standards are an extension of IEC 60601-1:2005, the general standard. Is your company ready for the implications of these standards as you will have regulatory requirements for the HHE standard come up soon (depending on the country of concern) and it will be similar once the EMS standard is published.
In this audio conference, Leo Eisner guides you through IEC 60601-1-11:2010 with new definitions, additions and changes to the general standard. The presentation reviews the significant issues including earthing requirements and additional mechanical and environmental tests. It also compares the requirements of each standard to provide a perspective on what the EMS may look like vs. the HHE standard.
Ease your development stress for HHE and EMS devices with detailed guidance from a leading expert!
Get up to speed on the latest and developing requirements for the electro-medical collateral standards for the home healthcare environment (HHE) IEC 60601-1-11:2010 and the proposed IEC 60601-1-12 standard for the emergency medical environment (EMS). These two collateral standards are an extension of IEC 60601-1:2005, the general standard. Is your company ready for the implications of these standards as you will have regulatory requirements for the HHE standard come up soon (depending on the country of concern) and it will be similar once the EMS standard is published.
In this audio conference, Leo Eisner guides you through IEC 60601-1-11:2010 with new definitions, additions and changes to the general standard. The presentation reviews the significant issues including earthing requirements and additional mechanical and environmental tests. It also compares the requirements of each standard to provide a perspective on what the EMS may look like vs. the HHE standard.
Ease your development stress for HHE and EMS devices with detailed guidance from a leading expert!
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