Avoiding FDA 483s, Warning Letters and Recalls with Harmonized Supplier Qualification

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.

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.

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.

QA Oversight of Contractors

is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc and airs on Tuesday, August 24th, 2010. For more details or to register for this event, please visit our website at www.fxconferences.com

Managing contractors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.

This audio conference discusses what a quality agreement is and how to use it as a tool in managing your contractors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.

Using Practical Statistics to Interpret Stability Results

is being presented by Steven Walfish, President, of Statistical Outsourcing Services and airs on Wednesday, July 21st, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

The ICH Q1 is not prescriptive on which statistics are most appropriate for reporting stability data. More importantly, using the incorrect statistics can lead to incorrect conclusions.

In this audio conference, our speaker reviews the statistical concepts used in stability analysis, using an overview of the ICH Q1 guidance as the framework for discussion. The presentation looks at linear models as the statistical tool used for stability analysis, but also covers methods for dealing with data that does fit the linear model. Typically, regression analysis is used to assess stability, and in this audio conference the speaker highlights the assumptions and risks of regression. Finally, the presentation draws on real-life examples to discuss the covariance model for determining poolability of the lots.

QA Oversight of Vendor Management

is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc. and airs on Wednesday, March 17, 2010. For more details or to register, please visit our site at www.fxconferences.com

Managing vendors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.

This conference discusses what a quality agreement is and how to use it as a tool in managing your vendors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.

QA Oversight of Vendor Management

Managing vendors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.

This conference discusses what a quality agreement is and how to use it as a tool in managing your vendors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.

QA Oversight of Vendor Management is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc. and airs on Tuesday, October 13, 2009. For more details or to register, please visit our site at www.fxconferences.com