Good Documentation Guideline (Chapter <1029> USP) 2018

Topics

• Purpose of development of this chapter
• History of the chapter as to how and why it was created
• Retention of documents
• Chapter outline
  • Data collection & recording
  • Principles of Good Documentation
  • Laboratory records
  • Different types of GMP Documents:
  • Deviations and investigations
  • Equipment-related documentation
  • Certificate of Analysis (C of A)*
  • Batch records
  • Protocols & reports*
  • Standard Operating Procedure (SOP)*
  • Training documentation
  • Analytical procedures*

Who should Attend

Attendees with responsibilities in:

• Compliance
• Regulatory
• Quality
• Audit
• Scientists
• R&D
• Clinical Research
• Documentation and Validation
• Engineering and Manufacturing
• Lab Managers