GDP – Good Documentation Practices

Course Description
Whether you work in production or in a laboratory, whether you conduct investigations or finalize product release, sound data and information is essential to success and compliance. Poor or incomplete documentation accounts for more noncompliance during audits than virtually anything else. FDA regulations and international standards require regulated organizations to establish compliant documentation processes. However, it is often difficult to know just how much documentation is enough.

This course is designed to provide participants with the Good Documentation Practices they need to dramatically improve their organizations’ efficiency and effectiveness.

Who Should Attend
This course is appropriate for anyone who authors, reviews, and audits documents and records in all industries, including: manufacturing/production personnel, laboratory personnel, research and development associates, document control associates, and quality assurance auditors.

Learning Objectives
Upon completion of this course, participants will have a comprehensive understanding of GDP definition and requirements.

Course Outline

  • What are Documentation and a Documentation System?
  • Types of Documents
  • Good Documentation Practices
  • Good Documentation Requirements
  • Documentation Processing and Control
  • Guidance Documents for GDP

Course Format
8 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities and on-site at your organization

Always Keep Improving!