Good Documentation Practices (GDPs) in a cGMP Environment

Notes upon research


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.



  • 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
This course is currently not scheduled.  Contact us to request a date that works for you!

Course Request

Use this form to request a course that is not currently scheduled.
  • Please select the course(s) you'd like to request:

Course Features

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