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International GMPs: Complying with Requirements in the U.S., EU and Japan

Return to Your Job with a Detailed Matrix that Highlights the Differences in GMP Requirements in the U.S., EU and Japan!

  • 02/09/2009 - 02/10/2009

    Princeton, NJ

  • 02/23/2009 - 02/24/2009

    Toronto, Canada

  • 03/16/2009 - 03/17/2009

    San Francisco, CA

Course Description

Although the U.S., EU and Japan - the three largest markets for drugs and medical devices - have made an effort to harmonize Good Manufacturing Practice (GMP) requirements, significant differences remain. To compete globally, companies must be aware of these significant differences and plan their operations accordingly. In this two-day training course, the points of differentiation among the GMP requirements of the U.S., EU and Japan are examined in thorough detail.  The course is designed to be highly interactive; for example, participants create a matrix of international requirements they will walk away with and use on the job. The course also clarifies what to expect from an inspection by foreign regulatory bodies. By the end of this course, participants return to work with the knowledge and skills needed to meet international requirements and avoid the consequences of non-compliance, including drastic consequences such as plant closures.

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