Risk Management in a Regulatory Context

Recorded Date: December 2004
Course Type: Recorded Webinar
Speaker: David Selby, PhD, Selby Hope International
Duration: 118 minutes

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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.