is being presented by John Avellanet, Managing Director & Principal, with Cerulean Associates LLC and airs on Tuesday, September 27th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The FDA’s Office of Compliance is reorganizing to better address the challenges of globalization, regulatory harmonization and controlling a global supply chain. Part of FDA’s changes include increased citation of ICH guidance in Warning Letters and FDA Form 483s. And FDA inspectors are now being trained on ICH, GHTF and PIC/S guidelines when it comes to auditing firms for supplier control. Are you ready for the globalized FDA inspector?
This audio conference presentation provides attendees with a roadmap to successfully integrate regulatory harmonization and risk management into supplier selection, qualification, and management. The presentation highlights current FDA inspector thinking and questions to prepare for, along with a review of the hidden risks that companies inadvertently stumble into when transitioning to global supplier qualification and management. Our speaker also walks attendees, step-by-step, through the best practices necessary to implement a successful program that meets the challenges of 21st century global supply chain and current FDA inspector expectations.
Showing posts with label ghtf. Show all posts
Showing posts with label ghtf. Show all posts
Monday, August 29, 2011
Friday, June 24, 2011
Using FDA’s Regulatory Harmonization to Better Manage a Global Supply Chain
is being presented by John Avellanet, President, of Cerulean Associates LLC and airs on Wednesday, July 27th, 2011. For more details or to register, please visit our site at www.fxconferences.com
The FDA’s Office of Compliance is reorganizing this year to better address the challenges of globalization, regulatory harmonization and controlling a global supply chain. Part of FDA’s changes include increased citation of ICH guidance in Warning Letters and FDA Form 483s. And FDA inspectors are now being trained on ICH, GHTF and PIC/S guidelines when it comes to auditing firms for supplier control. Are you ready for the globalized FDA inspector?
This audio conference presentation provides attendees with a roadmap to successfully integrate regulatory harmonization and risk management into supplier selection, qualification, and management. Presented by international supplier management and lean compliance expert John Avellanet, author of the acclaimed book, "Get to Market Now! Turn FDA Compliance into a Competitive Edge", the audio conference highlights current FDA inspector thinking and questions to prepare for, along with a review of the hidden risks that companies inadvertently stumble into when transitioning to global supplier qualification and management. Mr. Avellanet also walks attendees, step-by-step, through the best practices necessary to implement a successful program that meets the challenges of 21st century global supply chain and current FDA inspector expectations.
The FDA’s Office of Compliance is reorganizing this year to better address the challenges of globalization, regulatory harmonization and controlling a global supply chain. Part of FDA’s changes include increased citation of ICH guidance in Warning Letters and FDA Form 483s. And FDA inspectors are now being trained on ICH, GHTF and PIC/S guidelines when it comes to auditing firms for supplier control. Are you ready for the globalized FDA inspector?
This audio conference presentation provides attendees with a roadmap to successfully integrate regulatory harmonization and risk management into supplier selection, qualification, and management. Presented by international supplier management and lean compliance expert John Avellanet, author of the acclaimed book, "Get to Market Now! Turn FDA Compliance into a Competitive Edge", the audio conference highlights current FDA inspector thinking and questions to prepare for, along with a review of the hidden risks that companies inadvertently stumble into when transitioning to global supplier qualification and management. Mr. Avellanet also walks attendees, step-by-step, through the best practices necessary to implement a successful program that meets the challenges of 21st century global supply chain and current FDA inspector expectations.
Wednesday, March 16, 2011
Global Clinical Trials & ISO 14155 Compliance – Are You Ready to Update
is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, April 13th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Are your quality systems for clinical trials compliant with ISO 14155? ISO 14155: The Clinical Investigation of Medical Devices for Human Subjects is an international standard designed to guide companies as they fulfill the regulatory requirements for international clinical trials. With over 30 pages of detailed required elements in Part 1: General Requirements and Part 2: The Clinical Investigation Plan, ensuring your systems are compliant with every component of the standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements.
This presentation is especially timely, since the ISO 14155 standard has been undergoing revision to become more consistent with the Global Harmonization Task Force (GHTF) and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) documents, to ensure data generated anywhere in the world meets minimum standards.
This presentation is designed to make sure each member of the clinical team fully understands what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day- to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 along with the clinical trial guidelines of the GHTF and the ICH GCPs, and useful tips on how to prepare for changes to in-house quality systems to ensure compliance with the new standards when they are released.
Are your quality systems for clinical trials compliant with ISO 14155? ISO 14155: The Clinical Investigation of Medical Devices for Human Subjects is an international standard designed to guide companies as they fulfill the regulatory requirements for international clinical trials. With over 30 pages of detailed required elements in Part 1: General Requirements and Part 2: The Clinical Investigation Plan, ensuring your systems are compliant with every component of the standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements.
This presentation is especially timely, since the ISO 14155 standard has been undergoing revision to become more consistent with the Global Harmonization Task Force (GHTF) and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) documents, to ensure data generated anywhere in the world meets minimum standards.
This presentation is designed to make sure each member of the clinical team fully understands what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day- to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 along with the clinical trial guidelines of the GHTF and the ICH GCPs, and useful tips on how to prepare for changes to in-house quality systems to ensure compliance with the new standards when they are released.
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.
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, December 13, 2010
Global Clinical Trials & ISO 14155 Compliance – Are You Ready to Update?
is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, January 19th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Are your quality systems for clinical trials compliant with ISO 14155? ISO 14155: The Clinical Investigation of Medical Devices for Human Subjects is an international standard designed to guide companies as they fulfill the regulatory requirements for international clinical trials. With over 30 pages of detailed required elements in Part 1: General Requirements and Part 2: The Clinical Investigation Plan, ensuring your systems are compliant with every component of the standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements.
This presentation is especially timely, since the ISO 14155 standard has been undergoing revision to become more consistent with the Global Harmonization Task Force (GHTF) and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) documents, to ensure data generated anywhere in the world meets minimum standards.
This presentation is designed to make sure each member of the clinical team fully understands what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day- to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 along with the clinical trial guidelines of the GHTF and the ICH GCPs, and useful tips on how to prepare for changes to in-house quality systems to ensure compliance with the new standards when they are released.
Are your quality systems for clinical trials compliant with ISO 14155? ISO 14155: The Clinical Investigation of Medical Devices for Human Subjects is an international standard designed to guide companies as they fulfill the regulatory requirements for international clinical trials. With over 30 pages of detailed required elements in Part 1: General Requirements and Part 2: The Clinical Investigation Plan, ensuring your systems are compliant with every component of the standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements.
This presentation is especially timely, since the ISO 14155 standard has been undergoing revision to become more consistent with the Global Harmonization Task Force (GHTF) and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) documents, to ensure data generated anywhere in the world meets minimum standards.
This presentation is designed to make sure each member of the clinical team fully understands what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day- to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 along with the clinical trial guidelines of the GHTF and the ICH GCPs, and useful tips on how to prepare for changes to in-house quality systems to ensure compliance with the new standards when they are released.
Tuesday, November 16, 2010
Risk-Based CAPA - New Guidelines and Expectations
is being presented by Vinny Sastri, President, of Winovia LLC and airs on Tuesday, December 14th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Why does a significant percentage of all warning letters for medical devices and pharmaceuticals continue to be CAPA-related even though critical thinking and problem solving methodologies proliferate in the industry? In November 2009, the Global Harmonization Task Force (GHTF) issued a draft, proposed guidance document that provides the latest thinking and approach of the regulatory bodies on CAPA. This includes the use of risk-based processes and decisions.
This audio conference discusses how to use risk-based decisions in implementing, prioritizing and conducting CAPA projects and processes. In addition it provides organizational best practices to enable effective CAPA systems.
Why does a significant percentage of all warning letters for medical devices and pharmaceuticals continue to be CAPA-related even though critical thinking and problem solving methodologies proliferate in the industry? In November 2009, the Global Harmonization Task Force (GHTF) issued a draft, proposed guidance document that provides the latest thinking and approach of the regulatory bodies on CAPA. This includes the use of risk-based processes and decisions.
This audio conference discusses how to use risk-based decisions in implementing, prioritizing and conducting CAPA projects and processes. In addition it provides organizational best practices to enable effective CAPA systems.
Friday, February 19, 2010
Good Auditing Practices for EU Notified Body Audits
is being presented by Theo Nusselder, Founder & Director, of cePartner4u and airs on Tuesday, March 30, 2010. For more details or to register, please visit our site at www.fxconferences.com
Are you ready for a Notified Body audit? The European Medical Devices Directive requires that manufacturers of medium- and high-risk devices apply for an assessment of the manufacturing process and the technical documentation. The manufacturer is responsible for the design, manufacture, packaging and labeling of a device before it is placed on the market, regardless of whether these operations are carried out by the manufacturer or outsourced to a third party. The quality system must ensure that the products conform to the requirements of the Directive at every stage, from design to final inspection.
The Notified Body must audit the quality system to determine whether it meets the requirements, and the auditors have thorough knowledge of the rules on the inspections. Such rules are given in ISO requirements for audit and certification of management systems (ISO 19011:2002) and GHTF guidelines for Regulatory Auditing of Medical Device Manufacturers (GHTF/SG4/N28R4:2008). In this audio conference presentation attendees learn how to use these rules as a guide to Good Auditing Practice for the Notified Body assessment and CE-certification procedures.
Are you ready for a Notified Body audit? The European Medical Devices Directive requires that manufacturers of medium- and high-risk devices apply for an assessment of the manufacturing process and the technical documentation. The manufacturer is responsible for the design, manufacture, packaging and labeling of a device before it is placed on the market, regardless of whether these operations are carried out by the manufacturer or outsourced to a third party. The quality system must ensure that the products conform to the requirements of the Directive at every stage, from design to final inspection.
The Notified Body must audit the quality system to determine whether it meets the requirements, and the auditors have thorough knowledge of the rules on the inspections. Such rules are given in ISO requirements for audit and certification of management systems (ISO 19011:2002) and GHTF guidelines for Regulatory Auditing of Medical Device Manufacturers (GHTF/SG4/N28R4:2008). In this audio conference presentation attendees learn how to use these rules as a guide to Good Auditing Practice for the Notified Body assessment and CE-certification procedures.
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