Good Documentation Practices (GDPs) in a cGMP Environment

$150.00
Notes upon research

COURSE DESCRIPTION

Numerous types of documents are used in regulated industries, serving functions that include communicating instructions and information, and recording information. Participants in this course will learn the history of GDPs, strategies for implementing compliance, as well as standards and practices for accurately completing cGMP paper records. Requirements of 21 CFR 11, Electronic Records; Electronic Signatures, will also be addressed.

 

LEARNING OUTCOMES

  • List the various documentation types and their applications
  • Describe documentation and document control with respect to regulatory compliance
  • Discuss strategies for, minimizing and correcting errors
  • Review examples of FDA Warning letters and discuss how they can be avoided
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Course Features

  • Lectures 0
  • Hands-On Training 0
  • Duration 2 hours
  • Skill level All Levels
  • Wet Lab No
  • Max Students 24
  • Assessments Yes
$150.00