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What our members say

ISPE has had great impact on the industry by providing a platform where industry, regulators, and academia can come together for the good of humanity in a non-threatening, neutral, and scientific-based environment, where we can work together with none of the boundaries that our organizations put on us.

Ali M. Afnan, Ph.D., Process Analytical Technologist
FDA/CDER, USA

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Recorded Webinars
Leveraging Commissioning to Support a Risk-Based Approach to Qualification

Speaker
Robert Chew, Vice President, Commissioning Agents Description

Attempting to qualify a system that has not been properly commissioned leads to excessive deviations, cost, and schedule slippage. Conversely, conducting qualification as "business as usual" when a comprehensive commissioning program has been instituted results in needless extra costs and time on the critical path. Finally, because commissioning often involves extensive troubleshooting, debugging, and physical or functional design changes, there needs to be a final qualification check once such changes have been made. This Recorded On-line Seminar explores how to balance these conflicting factors and achieve an efficient, integrated commissioning and qualification program. It also explores the tools and techniques for implementing an integrated commissioning and qualification process. This Recorded On-line Seminar focuses on how to make these two activities - Commissioning and Qualification - complimentary, sequenced, and value-added, with minimal overlap.

At the end of this Recorded On-line Seminar, delegates are able to reference and package commissioning documentation for use by qualification, shrink the focus of qualification to just the critical aspects of facilities, utilities, and equipment, and use commissioning to both start-up, shake down systems, and support qualification. Delegates are also able to integrate automation testing with overall C&Q testing and structure a project change management system that is beneficial but not burdensome.

This Recorded On-line Seminar benefits project managers, project engineers, quality assurance and validation professionals, and commissioning professionals.

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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 CPIPSM Recorded Webinars?

CPIPSM Recorded Webinars are a group of Recorded Webinarswas developed to help individuals in preparation for the Certified Pharmaceutical Industry ProfessionalSM (CPIPSM) examination..

The Certified Pharmaceutical Industry ProfessionalSM (CPIPSM) 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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