Quality: Documentation

High-level overview of quality documentation principles and practices.

This course is the second in our three-part Quality series:

  1. Quality: Events
  2. Quality: Documentation
  3. Quality: Miscellaneous

This course provides a high-level overview of essential quality documentation practices and SOPs. Rather than focusing solely on completing individual forms, this course explains why elements such as SOPs, batch records, change control forms, and supporting documentation are critical to a robust pharmaceutical quality system. You’ll learn the key principles behind effective document creation, control, and lifecycle management, ensuring you understand their role in maintaining compliance and operational excellence.

Course Modules/Learning Objectives

  • Regulated Environments
  • Core Principles of Quality Records
  • Managing the Lifecycle
  • Change Control and Documentation Impact
  • Document Issuance and Version Control
  • Archival, Retention, and Retrieval of Quality Documentation
  • Quality in Action – Learning Through Scenarios
  • Documentation: Training, Qualification, and Compliance
  • Documentation: The Backbone of Quality Systems

Registration Fee

MemberNonmember
US$270US$300 

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For an enhanced learning experience, ISPE also offers these learning activities as live courses and gives you an opportunity to learn with a live instructor, ask questions, and participate in exercises. View upcoming courses