Biologic vs. Non-biologic: Current FDA Thinking on IVDs

In the United States, in vitro diagnostic products are classified and reviewed under two separate FDA Centers, depending on whether the product is intended to be used to diagnose a condition, predict if a particular treatment will be effective or monitor the effect of a treatment, or if it is intended to be used in the testing of transfusable blood or cellular products.

In this audio conference we highlight the differences in the two product review processes between the Centers and provide insight into their expectations regarding information required in submissions and following product approval. Recent Guidance Documents issued by FDA are discussed.

Biologic vs. Non-biologic: Current FDA Thinking on IVDs was presented by Ann Quinlan-Smith & Pamela J. Vaughan, President & Senior Principal Consultant, with Alquest, Inc. and aired on 2008-02-28. For more details or to download this event, please visit our site at www.fxconferences.com

Implementing GMP for Combination Products: What Applies When?

Combination product manufacturers are faced with a major challenge to implement a quality system that complies with applicable FDA Good Manufacturing Practices (GMPs) and Quality System Requirements (QSRs). For 10 years, FDA has been progressively developing regulations for this complex area, yet has provided very few formal guidance documents to help manufacturers.

In this audio conference, you learn how to navigate the regulations to develop effective plans for combination products. Linda Alexander gives you specific examples of current FDA expectations and accepted practices, and teaches you how to customize and apply them to comply. Explore the history of combination approvals in the US, case studies, and important trends and issues for the future.

Implementing GMP for Combination Products: What Applies When? was presented by Linda Alexander, CEO and Founder, with Alquest and aired on 2008-09-18. For more details or to download this conference, please visit our site at www.fxconferences.com

How to Successfully Execute an FDA Product Recall

All industries regulated by FDA are expected to have robust product designs, well-controlled manufacturing processes, effective quality control measures, and a comprehensive quality system to identify potential problems, investigate them, and take appropriate actions. Product recalls are an unwelcome, but important, part of the spectrum of corrective and preventive actions that industry uses.

In this audio conference, the speaker reviews recall regulations, initiation and conduct of recalls, and provides tactical recommendations, focusing on medical devices, but with broader applicability. The presentation serves as an introduction for those new to the topic, and also as a refresher for those already familiar with recalls.

How to Successfully Execute an FDA Product Recall is being presented by Dr. Bruce MacFarlane, Principal Project Manager, with Alquest and airs on Tuesday, June 23, 2009. For more details or to register please visit our site at www.fxconferences.com

Biologic vs. Non-biologic: Current FDA Thinking on IVDs

In the United States, in vitro diagnostic products are classified and reviewed under two separate FDA Centers, depending on whether the product is intended to be used to diagnose a condition, predict if a particular treatment will be effective or monitor the effect of a treatment, or if it is intended to be used in the testing of transfusable blood or cellular products.

In this audio conference we highlight the differences in the two product review processes between the Centers and provide insight into their expectations regarding information required in submissions and following product approval. Recent Guidance Documents issued by FDA are discussed.

Biologic vs. Non-biologic: Current FDA Thinking on IVDs was presented by Ann Quinlan-Smith & Pamela J. Vaughan, President & Senior Principal Consultant, with Alquest, Inc. and aired on 2008-02-28. For more details about purchasing a download, please visit our site www.fxconferences.com

Implementing GMP for Combination Products: What Applies When?

For 10 years now FDA has been progressively developing its regulation of the complex product area known as combination products, with very few formal guidance documents for industry. Combination product manufacturers are faced with the challenge of deciding how to implement a quality system that is compliant with applicable Good Manufacturing Practices and Quality System Requirements.

In this audio conference, our speaker discusses the applicable guidance and current thinking on meeting FDA expectations for combination products, sharing specific examples of accepted practices and how FDA regulations and guidance are currently being applied. The presentation also examines the recent history of combination product approvals in the US, as well as important trends and issues for the future.

Implementing GMP for Combination Products: What Applies When? is presented Thursday, Sept. 18, 2008 by Linda Alexander, CEO & Founder, of Alquest. For more information, please visit our site www.fxconferences.com

Implementing GMP for Combination Products: What Applies When?

For 10 years now FDA has been progressively developing its regulation of the complex product area known as combination products, with very few formal guidance documents for industry. Combination product manufacturers are faced with the challenge of deciding how to implement a quality system that is compliant with applicable Good Manufacturing Practices and Quality System Requirements.

In this audio conference, our speaker will discuss the applicable guidance and current thinking on meeting FDA expectations for combination products, sharing specific examples of accepted practices and how FDA regulations and guidance are currently being applied. The presentation will also examine the recent history of combination product approvals in the US, as well as important trends and issues for the future.

Implementing GMP for Combination Products: What Applies When? is presented by Linda Alexander, CEO & Co-Founder, Alquest, Inc. For more details, please visit our site www.fxconferences.com