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.

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.

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

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