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

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