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Writing Reports for Failure Investigations and Process Deviations

Create a Thorough, Well-Written and Regulatory Sound Report!

  • 01/26/2009 - 01/27/2009

    Princeton, NJ

Course Description

Inadequate failure investigations continue to be a major GMP deficiency cited during routine FDA inspections. Although the agency recognizes that failures are a part of business, it also expects firms to complete comprehensive investigations, apply scientific judgment, learn from the experience and provide permanent solutions to the problems. This course clarifies the scope of relevant FDA guidance for failure investigations and teaches essential skills necessary to ensure compliant documentation. Participants will examine each step of an effective investigation and learn what documentation is required along the way. Techniques are discussed to avoid common obstacles to success and to resolve conflicts. Throughout the course, participants will improve their documentation skills through completion of in-depth writing exercises and analysis of technical writing samples.

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