The FDA's recent introduction of risk management into GMP facility inspections has caused the pharmaceutical industry to take a serious look at how it does business. This Recorded Webinar will provide an overview of the issues commonly faced in a highly regulated industry and demonstrate, though current examples, how the industry is responding to the FDA challenge.

This Recorded Webinar will bring you up to date on the current thinking for applying risk management in the highly regulated pharmaceutical manufacturing arena, in the wake of the release of the FDA's initiative, Pharmaceutical GMPs for the 21st Century - A Risk-Based Approach. You'll also hear examples of how the FDA is approaching inspections and how the risk management concept will evolve into the future.

Learning Objectives:

• The principles of risk management and the regulatory expectations
• Use of risk management in validation planning
• Risk management for applying controls to electronic records
• Understand the implications of the FDA's risk-based approach for the pharmaceutical industry
• Discuss how the initiative is developing
• Appreciate the issues raised by examining current examples.

Who Should Attend:

This Recorded Webinar is essential for all professionals involved in the pharmaceutical supply chain including production and operations managers, quality assurance and quality control executives, process engineers, and validation executives.

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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