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FDA Compliance

Event: Moving ICH Q9 From Theory to Practice

An interactive workshop presented by LearningPlus and FDAnews

Published: Tuesday, October 6, 2009 - 16:36

(FDAnews: Falls Church, VA) -- Earn 12 RAC credits while you discover field-tested, ICH Q9 risk management strategies that work for drugs and biologics, in “Applying Quality Risk Management Principles: Moving ICH Q9 from Theory to Practice,” an interactive workshop presented by LearningPlus and FDAnews.

The event will be held Oct. 29–30, at the Hyatt Regency Princeton in Princeton, New Jersey. 

Register today: attendance is limited.

The Food and Drug Administration (FDA) and international regulatory authorities have made risk management a top priority. Increasingly, regulators are conducting stricter inspections and looking under every rock to find risk management related problems.

The current economic climate is difficult enough; you don’t need the FDA crawling all over your offices due to a risk management failure.

The ICH Q9 guidance is your starting point, but you need more—and fast. LearningPlus and FDAnews have developed a one-of-a-kind workshop that will teach you proven methods to transform global quality risk management principles into workable practices. In two packed days you’ll learn strategies you can use in “the real world” to keep your products compliant.

You need field-tested tactics to not simply control risk, but reduce it altogether, boosting your profits and productivity. You also need an intensive crash course to give you the determination to use these new risk management tools—without sucking up your time.

Learn to control risk and avoid warning letters at every stage of your product’s life cycle. The tools in this workshop show you how.

A 25-year veteran and award-winning trainer, James Vesper, will work closely with you for two full days, sharing proven risk management tools that boost both productivity and profits, such as:

  • How to choose the right risk management team (critical if you want to control and mitigate risk)
  • Six tools that gauge the severity of a failure event—HazOp, FTA and others
  • Best practices for proactive decision making: know when to accept and control a risk, or when you must eliminate it entirely
  • How to craft validation documents that satisfy ICH Q9, regulators, and investigators
  • Updated strategies to prepare for risk-based inspections
  • Six accident models that let you identify a hazard and its source (and help you to steer clear of common misconceptions that trip up many firms)
  • Why a two-part risk assessment question is better, and how to create it
  • With the FDA leaning so heavily on a risk-based approach to judge the compliance of your product, does a reactive, “risk control scramble” really make sense?

Click here to view the brochure.

Preapproved by RAPS: upon full completion of the Applying Quality Risk Management Principles workshop, you’ll be eligible for 12 credits toward your RAC recertification.

Enroll online or call toll free (888) 838-5578 or (703) 538-7600.

Date and Location
Oct. 29–30

Hyatt Regency Princeton
102 Carnegie Center
Princeton, NJ  08540


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