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.
Showing posts with label risk management. Show all posts
Showing posts with label risk management. Show all posts
Thursday, February 24, 2011
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.
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.
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.
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.
Wednesday, September 8, 2010
Statistical Concepts of Medical Device Process Validation
is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Tuesday, October 5th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Process validation is an important element in medical device manufacturing, and this audio conference looks at the underlying statistical concepts to perform an effective process validation, examining elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485.
When you cannot (or do not) fully verify process results by subsequent inspection and test this leads to sampling plans, and in this presentation our speaker discusses the use of attribute sampling plans in this context. When you validate the process with a high degree of assurance, this means your process achieves a certain process capability. The presentation looks at the concepts of process capability, especially the use of common processes capability indices, Cp and Cpk.
Process validation often employs three phases, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). One role of OQ explores the parameter space that defines the process and selects challenge points as part of the qualification protocol. This naturally leads to Designed Experiments as the exploratory tool. Designed experiments determine the limits of the parameter space for the process. The same techniques, especially full and fractional factorial experiments, can establish “worst case” conditions that become challenge points for the OQ phase of process validation.
Lastly, Risk Management (ISO 14971) includes production information. This leads directly to validated processes since these are often the production processes that carry the greatest risk.
Process validation is an important element in medical device manufacturing, and this audio conference looks at the underlying statistical concepts to perform an effective process validation, examining elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485.
When you cannot (or do not) fully verify process results by subsequent inspection and test this leads to sampling plans, and in this presentation our speaker discusses the use of attribute sampling plans in this context. When you validate the process with a high degree of assurance, this means your process achieves a certain process capability. The presentation looks at the concepts of process capability, especially the use of common processes capability indices, Cp and Cpk.
Process validation often employs three phases, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). One role of OQ explores the parameter space that defines the process and selects challenge points as part of the qualification protocol. This naturally leads to Designed Experiments as the exploratory tool. Designed experiments determine the limits of the parameter space for the process. The same techniques, especially full and fractional factorial experiments, can establish “worst case” conditions that become challenge points for the OQ phase of process validation.
Lastly, Risk Management (ISO 14971) includes production information. This leads directly to validated processes since these are often the production processes that carry the greatest risk.
Tuesday, July 6, 2010
Strategic Immunogenicity Planning for Successful Biosimilar Development
is being presented by Ana T. Menendez, Senior Director, Biotechnology, with Catalent Pharma Solutions and airs on Tuesday, August 10th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
The FDA has recently provided a pathway to biosimilar development, which is expected to increase annual biosimilar revenues from $0.06 billion in 2008 to $1.95 billion by 2014 (Visiongain Report Biosimilars and Follow-on Biologics 2009-2024, 2009).
Biopharmaceuticals demonstrate therapeutic success because of their excellent targeting ability. This advantage is tempered with the danger of inducing an unwanted immune response in patients. Immunogenicity programs need to establish immunogenic similarity between innovator and biosimilar. Quick identification, characterization and interpretation of antibody response is crucial to interpret changes in the potency and safety of the drug.
The first part of this audio conference reviews intrinsic and external factors that can significantly impact immunogenicity risk management. The next two sections explain key documents (regulatory & industry), methods and timeline expectations to assure compliance. The last section discusses relevant case studies that highlight the impact of immunogenicity on the success of clinical trials.
The FDA has recently provided a pathway to biosimilar development, which is expected to increase annual biosimilar revenues from $0.06 billion in 2008 to $1.95 billion by 2014 (Visiongain Report Biosimilars and Follow-on Biologics 2009-2024, 2009).
Biopharmaceuticals demonstrate therapeutic success because of their excellent targeting ability. This advantage is tempered with the danger of inducing an unwanted immune response in patients. Immunogenicity programs need to establish immunogenic similarity between innovator and biosimilar. Quick identification, characterization and interpretation of antibody response is crucial to interpret changes in the potency and safety of the drug.
The first part of this audio conference reviews intrinsic and external factors that can significantly impact immunogenicity risk management. The next two sections explain key documents (regulatory & industry), methods and timeline expectations to assure compliance. The last section discusses relevant case studies that highlight the impact of immunogenicity on the success of clinical trials.
Monday, July 5, 2010
A Practical Approach to Medical Device Risk Management
is being presented by Harvey Rudolph, Ph.D., HRRM, LLC, Risk Management Consultant and airs on Tuesday, August 3rd, 2010. For more details or to register please visit our site at www.fxconferences.com
Risk management is required by almost all regulatory bodies and is necessary for implementing many standards that medical device manufacturers use in designing and developing their products. Over the past ten years, most manufacturers have tried to model their risk management system on the one described in ISO 14971, because that is the one accepted by most regulatory bodies and referenced in most standards. However, myriad problems have been encountered in trying to implement risk management within existing quality management systems. Why is this? If ISO 14971 is so great, why isn’t it easier to do? What are the factors inhibiting success in making risk management work? In this audio conference, leading risk management expert Dr. Harvey Rudolph discusses some of the major issues facing medical device companies, and practical solutions.
Risk management is required by almost all regulatory bodies and is necessary for implementing many standards that medical device manufacturers use in designing and developing their products. Over the past ten years, most manufacturers have tried to model their risk management system on the one described in ISO 14971, because that is the one accepted by most regulatory bodies and referenced in most standards. However, myriad problems have been encountered in trying to implement risk management within existing quality management systems. Why is this? If ISO 14971 is so great, why isn’t it easier to do? What are the factors inhibiting success in making risk management work? In this audio conference, leading risk management expert Dr. Harvey Rudolph discusses some of the major issues facing medical device companies, and practical solutions.
Monday, June 28, 2010
Strategic Immunogenicity Planning for Successful Biosimilar Development
is being presented by Ana T. Menendez, Senior Director, Biotechnology, Catalent Pharma Solutions and airs on Tuesday, August 10th, 2010. For more details or to register please visit our site at www.fxconferences.com
The FDA has recently provided a pathway to biosimilar development, which is expected to increase annual biosimilar revenues from $0.06 billion in 2008 to $1.95 billion by 2014 (Visiongain Report Biosimilars and Follow-on Biologics 2009-2024, 2009).
Biopharmaceuticals demonstrate therapeutic success because of their excellent targeting ability. This advantage is tempered with the danger of inducing an unwanted immune response in patients. Immunogenicity programs need to establish immunogenic similarity between innovator and biosimilar. Quick identification, characterization and interpretation of antibody response is crucial to interpret changes in the potency and safety of the drug.
The first part of this audio conference reviews intrinsic and external factors that can significantly impact immunogenicity risk management. The next two sections explain key documents (regulatory & industry), methods and timeline expectations to assure compliance. The last section discusses relevant case studies that highlight the impact of immunogenicity on the success of clinical trials.
The FDA has recently provided a pathway to biosimilar development, which is expected to increase annual biosimilar revenues from $0.06 billion in 2008 to $1.95 billion by 2014 (Visiongain Report Biosimilars and Follow-on Biologics 2009-2024, 2009).
Biopharmaceuticals demonstrate therapeutic success because of their excellent targeting ability. This advantage is tempered with the danger of inducing an unwanted immune response in patients. Immunogenicity programs need to establish immunogenic similarity between innovator and biosimilar. Quick identification, characterization and interpretation of antibody response is crucial to interpret changes in the potency and safety of the drug.
The first part of this audio conference reviews intrinsic and external factors that can significantly impact immunogenicity risk management. The next two sections explain key documents (regulatory & industry), methods and timeline expectations to assure compliance. The last section discusses relevant case studies that highlight the impact of immunogenicity on the success of clinical trials.
Monday, June 21, 2010
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 Thursday, July 29th, 2010. For more details or to register, 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, May 11, 2010
Reducing the Impact of Risk Management on Development Budgets and Timelines
is being presented by Dr. Joy Frestedt, President & CEO, with Frestedt Incorporated and airs on Thursday, June 10th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Managing risk is an evolving specialty, and is becoming more critical thanks to increasingly strict global regulatory requirements for risk evaluation and management. No longer is simply recording and reporting adverse events sufficient to demonstrate due diligience for ensuring consumer safety. The need to proactively track, trend and attempt to predict risk-related issues is now critical and is a required part of every drug, device and biological design program.
This audio conference presentation looks at current trends in risk management, and how it can impact development budgets and timelines for drug and device manufacturers. Our speaker also shares valuable insight on practical activities and the training required to effectively reduce costs and speed timelines when conducting risk evaluation and mitigation strategies.
Managing risk is an evolving specialty, and is becoming more critical thanks to increasingly strict global regulatory requirements for risk evaluation and management. No longer is simply recording and reporting adverse events sufficient to demonstrate due diligience for ensuring consumer safety. The need to proactively track, trend and attempt to predict risk-related issues is now critical and is a required part of every drug, device and biological design program.
This audio conference presentation looks at current trends in risk management, and how it can impact development budgets and timelines for drug and device manufacturers. Our speaker also shares valuable insight on practical activities and the training required to effectively reduce costs and speed timelines when conducting risk evaluation and mitigation strategies.
Friday, April 9, 2010
Navigating the EU Regulatory Pathway for Advanced Therapy Medicinal Products
is being presented by Damien Bové, Consultant, Medical Tech Development & Regulations and airs on Thursday, May 6th, 2010. For more details or to register, please visit our site at www.fxconferences.com
For many years the European regulatory situation for advanced technologies such as stem cells and gene therapy was unclear and confusing. This presented a considerable challenge to those developing these technologies and those raising finance, as Europe represented a large portion of the global market. To tackle this, European regulators instituted the Advanced Therapies Medicinal Products (ATMP) regulatory pathway to bring clarity to the situation and make Europe an attractive destination for these technologies.
It has been one year since these new regulations came into force, and they appear to be working as intended. They provide clarity, risk management and an open environment for development and fundraising. In this presentation, our speaker explains the frameworks and how developers can use them to fast forward the development process.
For many years the European regulatory situation for advanced technologies such as stem cells and gene therapy was unclear and confusing. This presented a considerable challenge to those developing these technologies and those raising finance, as Europe represented a large portion of the global market. To tackle this, European regulators instituted the Advanced Therapies Medicinal Products (ATMP) regulatory pathway to bring clarity to the situation and make Europe an attractive destination for these technologies.
It has been one year since these new regulations came into force, and they appear to be working as intended. They provide clarity, risk management and an open environment for development and fundraising. In this presentation, our speaker explains the frameworks and how developers can use them to fast forward the development process.
Tuesday, February 9, 2010
An Integrated Approach to Managing Supply Chain Risk
Supply chain integrity has never been a bigger or more complex challenge for today's global businesses. Increased pressure for improved financial performance, combined with the need to optimize assets and resources, has resulted in a growing reliance on outsourcing and offshoring, often to developing countries. However, with the benefit of reduced costs comes the increased and more complex threat of supply chain interruption. Efficient supply chains are by definition lean, stretched and fragile, resulting in an ever-present threat of breakdown. While most organizations prepare themselves for the more obvious areas of weakness, breakdown can come from unanticipated causes and all too often, traditional insurance products fail to provide any, or sufficient, financial help.
Many companies fail to appraise the full extent of supply chain vulnerabilities, and as a result, are not totally confident that risks are managed within acceptable financial targets. In this session our experts explain how an integrated model for the identification, treatment and acceptance of risk can address these concerns.
An Integrated Approach to Managing Supply Chain Risk is being presented by James Bird & Andrew Tait, Partner, Jardine Lloyd Thompson & Principal, Core Risks Ltd. and airs on Tuesday, March 2, 2010. For more details or to register, please visit our site at www.fxconferences.com
Many companies fail to appraise the full extent of supply chain vulnerabilities, and as a result, are not totally confident that risks are managed within acceptable financial targets. In this session our experts explain how an integrated model for the identification, treatment and acceptance of risk can address these concerns.
An Integrated Approach to Managing Supply Chain Risk is being presented by James Bird & Andrew Tait, Partner, Jardine Lloyd Thompson & Principal, Core Risks Ltd. and airs on Tuesday, March 2, 2010. For more details or to register, please visit our site at www.fxconferences.com
Wednesday, January 13, 2010
Finding and Assessing Global Drug Development Partners
It takes, on average, somewhere around 15 years and a billion dollars to take a drug development project “from bench to bedside.” One factor contributing greatly to that protracted timeline is the significant difficulty in finding and then collaborating with qualified partners. The problem is exacerbated when development is taking place on a global scale. Asking colleagues and consultants might net you a recommendation for the largest CROs, but if you need a good regulatory consultant familiar with Chinese Investigator Document Review, for example, you could be out of luck. And even when a pharma company does identify a service provider, the interaction isn't straightforward: there is no simple way of searching for and comparing services, profiles and reputation.
There are myriad websites designed to help consumers find hotels and local businesses, and they have made these transactions much more transparent. However, the life sciences industry has lagged behind: companies still mainly generate leads on development partners largely by word of mouth and by attending industry trade shows and conferences. In this audio conference, our speaker explores new ways to connect, evaluate and engage drug development partners around the world.
Finding and Assessing Global Drug Development Partners is being presented by Jae Chung, Founder & CEO, of goBalto and airs on Tuesday, February 9, 2010. For more details or to register, please visit our site at www.fxconferences.com
There are myriad websites designed to help consumers find hotels and local businesses, and they have made these transactions much more transparent. However, the life sciences industry has lagged behind: companies still mainly generate leads on development partners largely by word of mouth and by attending industry trade shows and conferences. In this audio conference, our speaker explores new ways to connect, evaluate and engage drug development partners around the world.
Finding and Assessing Global Drug Development Partners is being presented by Jae Chung, Founder & CEO, of goBalto and airs on Tuesday, February 9, 2010. For more details or to register, please visit our site at www.fxconferences.com
Tuesday, December 29, 2009
Best Practices for Implementing ISO14971:2007
Learn how to put an effective risk management plan in place and fulfill the requirements of ISO14971
In the medical device development process, it has become a regulatory necessity to implement an effective risk management plan to fulfill the requirements of ISO14971. Manufacturers, however, still struggle to comply with ISO14971 and find a meaningful way to introduce risk management to the overall operating framework.
In this audio conference, Mr. Weber discusses the elements of risk management, the current interpretations of regulatory requirements, as well as advice on implementation of a compliant risk management process. ISO 14971:2007 helps companies input risk management strategies, it can help many types of businesses from software-based to broadband provision-related enterprises working with devices. Additionally, the presentation provides practical tips to comply with ISO14971, implement risk management, and minimize the administrative burdens imposed to handle the additional process.
Best Practices for Implementing ISO14971:2007 was presented by Markus Weber, Principal Consultant, with System Safety Inc. and aired on 2008-02-21. For more details or to download this event, please visit our site at www.fxconferences.com
In the medical device development process, it has become a regulatory necessity to implement an effective risk management plan to fulfill the requirements of ISO14971. Manufacturers, however, still struggle to comply with ISO14971 and find a meaningful way to introduce risk management to the overall operating framework.
In this audio conference, Mr. Weber discusses the elements of risk management, the current interpretations of regulatory requirements, as well as advice on implementation of a compliant risk management process. ISO 14971:2007 helps companies input risk management strategies, it can help many types of businesses from software-based to broadband provision-related enterprises working with devices. Additionally, the presentation provides practical tips to comply with ISO14971, implement risk management, and minimize the administrative burdens imposed to handle the additional process.
Best Practices for Implementing ISO14971:2007 was presented by Markus Weber, Principal Consultant, with System Safety Inc. and aired on 2008-02-21. For more details or to download this event, please visit our site at www.fxconferences.com
Thursday, December 10, 2009
An Integrated Approach to Managing Supply Chain Risk
Supply chain integrity has never been a bigger or more complex challenge for today's global businesses. Increased pressure for improved financial performance, combined with the need to optimize assets and resources, has resulted in a growing reliance on outsourcing and offshoring, often to developing countries. However, with the benefit of reduced costs comes the increased and more complex threat of supply chain interruption. Efficient supply chains are by definition lean, stretched and fragile, resulting in an ever-present threat of breakdown. While most organizations prepare themselves for the more obvious areas of weakness, breakdown can come from unanticipated causes and all too often, traditional insurance products fail to provide any, or sufficient, financial help.
Many companies fail to appraise the full extent of supply chain vulnerabilities, and as a result, are not totally confident that risks are managed within acceptable financial targets. In this session our experts explain how an integrated model for the identification, treatment and acceptance of risk can address these concerns.
An Integrated Approach to Managing Supply Chain Risk is being presented by James Bird & Andrew Tait, Partner, Jardine Lloyd Thompson & Principal, Core Risks Ltd. and airs on Wednesday, January 27, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Many companies fail to appraise the full extent of supply chain vulnerabilities, and as a result, are not totally confident that risks are managed within acceptable financial targets. In this session our experts explain how an integrated model for the identification, treatment and acceptance of risk can address these concerns.
An Integrated Approach to Managing Supply Chain Risk is being presented by James Bird & Andrew Tait, Partner, Jardine Lloyd Thompson & Principal, Core Risks Ltd. and airs on Wednesday, January 27, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Friday, October 30, 2009
Friday special - save 75% on "Hazard Analysis for Medical Devices Under IEC60601 and ISO14971"
If you have participated in hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time.
This presentation looks at what is required under IEC60601 and ISO14971, and provides guidance on how to motivate groups to perform hazard analyses, structure meetings effectively and make them meaningful. It discusses documentation formats and hazard evaluation strategies, as well as presenting ideas on how to get the most benefit out of the risk management process.
But hurry! If you purchase Hazard Analysis for Medical Devices Under IEC60601 and ISO14971 by November 5, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.
This presentation looks at what is required under IEC60601 and ISO14971, and provides guidance on how to motivate groups to perform hazard analyses, structure meetings effectively and make them meaningful. It discusses documentation formats and hazard evaluation strategies, as well as presenting ideas on how to get the most benefit out of the risk management process.
But hurry! If you purchase Hazard Analysis for Medical Devices Under IEC60601 and ISO14971 by November 5, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.
Thursday, October 29, 2009
Developing a Post-Approval Labeling Risk Management Strategy
Patient injured because of event described in black box warning: Company still liable, long established FDA approved warnings not sufficient...
Patient injured on generic drug: innovator company could be liable for inadequate warnings...
FDA-approved labeling is no longer a regulatory and liability safe zone. Companies face rapidly escalating FDA, product, reimbursement and patent liabilities tied to labeling management. Penalties, damages and fines are hitting billion-dollar-plus levels, with consideration of direct liability for executives being openly discussed. Traditional labeling development and management approaches that center on FDA approval and adverse event reporting are not up to the task of protecting companies and their executives. This audio conference explains what has happened over the last year and likely changes for the coming years and what to do now to position products for success and avoid liability or regulatory disaster.
Developing a Post-Approval Labeling Risk Management Strategy is being presented by Gary Gamerman, President, of Seraphim Life Sciences Consulting LLC and airs on Tuesday, December 1, 2009. For more details or to register, please visit our site at www.fxconferences.com
Patient injured on generic drug: innovator company could be liable for inadequate warnings...
FDA-approved labeling is no longer a regulatory and liability safe zone. Companies face rapidly escalating FDA, product, reimbursement and patent liabilities tied to labeling management. Penalties, damages and fines are hitting billion-dollar-plus levels, with consideration of direct liability for executives being openly discussed. Traditional labeling development and management approaches that center on FDA approval and adverse event reporting are not up to the task of protecting companies and their executives. This audio conference explains what has happened over the last year and likely changes for the coming years and what to do now to position products for success and avoid liability or regulatory disaster.
Developing a Post-Approval Labeling Risk Management Strategy is being presented by Gary Gamerman, President, of Seraphim Life Sciences Consulting LLC and airs on Tuesday, December 1, 2009. For more details or to register, please visit our site at www.fxconferences.com
Sunday, October 25, 2009
The EU Perspective on Risk Management
Does your company market its products in Europe, or are you planning to enter the EU market? Have you taken the requisite steps to address risk management? Risk management must be an integral part of global product development and commercialization.
In this audio conference Dr. Blesse will provide a detailed overview of EMEA's Guideline on Risk Management Systems for Medicinal Products for Human Use and its legislative background. He will also provide examples of why this new regulation should not be perceived as another threat to industry, and how it offers strategic options.
The EU Perspective on Risk Management was presented by Dr. Stefan Blesse, with Granzer Regulatory Consulting and aired on 2007-07-19. To download this event, or for more details please visit our site at www.fxconferences.com
In this audio conference Dr. Blesse will provide a detailed overview of EMEA's Guideline on Risk Management Systems for Medicinal Products for Human Use and its legislative background. He will also provide examples of why this new regulation should not be perceived as another threat to industry, and how it offers strategic options.
The EU Perspective on Risk Management was presented by Dr. Stefan Blesse, with Granzer Regulatory Consulting and aired on 2007-07-19. To download this event, or for more details please visit our site at www.fxconferences.com
Saturday, October 24, 2009
An Introduction to Analyzing Risk in Medical Devices
Medical device technology has become so advanced and diverse, it is extremely challenging to identify and anticipate all risks. Risk analysis is a regulatory requirement in which a medical device manufacturer is to identify a complete, unbiased picture of all possible hazards that could potentially be created by a device and design plans to avoid, mitigate, or control these hazards. The science of risk analysis and documentation of a risk management plan must incorporate the objective identification of defects or failures along with the subjective determinations of likelihood, severity, and acceptable risk limits during the entire life cycle of the medical device. This audio conference will provide an overview of risk analysis for medical devices, including information on the various international regulations with which manufacturers must comply.
An Introduction to Analyzing Risk in Medical Devices was presented by Amy Wise, Manager, Clinical Research, with PharmaNet and aired on 2008-07-31. For more details, or to download this conference please visit our site at www.fxconferences.com
An Introduction to Analyzing Risk in Medical Devices was presented by Amy Wise, Manager, Clinical Research, with PharmaNet and aired on 2008-07-31. For more details, or to download this conference please visit our site at www.fxconferences.com
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