This Recorded On-line Seminar, hosted by two senior staff members from the FDA's Center for Drug Evaluation and Research, explores the Agency's new draft guidance, "Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations." Issued in September 2004, the guidance describes a comprehensive quality systems (QS) model and highlights the model's consistency with the cGMP regulatory requirements for manufacturing human and veterinary drugs, including biological drug products. The guidance also explains how manufacturers implementing such quality systems can be in full compliance with parts 210 and 211. The QS guidance was developed by a working group formed to address the quality systems component of the FDA's Pharmaceutical cGMPs for the 21st Century Initiative. Part of that initiative included integrating quality systems and risk management approaches into existing programs to encourage the adoption of modern and innovative manufacturing technologies. The QS working group's objective was to determine how the cGMP regulations and the elements of a modern, comprehensive quality system fit together in today's manufacturing world. An in-depth understanding of the Quality Systems Approach will not only help assure compliance with cGMPs, but will also aid in improving customer satisfaction and achieving continuous improvement. Quality systems implementation has also been shown to improve efficiency and reduce costs in other industries.

In this Recorded On-line Seminar, FDA presenters address the QS guidance and its themes of quality management, quality assurance and risk management tools in addition to the quality control principles stressed by the cGMPs. The Recorded On-line Seminar also addresses the harmonization of the cGMPs and other non-U.S. pharmaceutical regulatory systems as well as the FDA's own medical device quality systems regulations.

At the end of this Recorded On-line Seminar, delegates will be able to:

• Discuss the driving forces behind the QS guidance 
• Understand management's role in a quality system and the characteristics that are shared by successful quality systems
• Describe the key concepts critical to any discussion of modern quality systems

Who Should Attend:

•  Professionals in regulatory compliance, manufacturing, engineering and process development
• Vendors engaged in facility design, equipment supply, component supply and validation.

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What is a Recorded Webinar?

Previously held webinars are available as recorded sessions, which you can view at your convenience. Registration orders are processed within two business days, after which participants will receive an e-mail confirmation with a link to the Recorded Webinar. After receiving the link to the Recorded Webinar, you have 15 days to view it.

What are CPIP^SM Recorded Webinars?

CPIP^SM Recorded Webinars are a group of Recorded Webinarswas developed to help individuals in preparation for the Certified Pharmaceutical Industry Professional^SM (CPIP^SM) examination..

The Certified Pharmaceutical Industry Professional^SM (CPIP^SM) credential recognizes “change agents” as the necessary ingredient to foster industry innovation and enhance drug product quality. The credential establishes a global competency standard for industry professionals, and candidates are assessed through demonstrated education, experience, and a rigorous examination. Completion of any of these seminars does not guarantee successful completion of the CPIP certification exam, and these seminars do not include every subject to the depth of what will be covered on the CPIP exam.

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