Good Documentation Guideline (Chapter 1029 USP) 2018

Topics

• Chapter outline
  • Data collection & recording
  • Principles of Good Documentation
• US Pharmacopeia General Chapter 1029
  • Purpose of development of this chapter
  • History of the chapter as to how and why it was created
• Different types of GMP Documents
  • Equipment-related documentation
  • Laboratory records
  • Batch records
  • Deviations and investigations
  • Standard Operating Procedure (SOP)*
  • Certificate of Analysis (C of A)*
  • Analytical procedures*
  • Protocols & reports*
  • Retention of documents
  • Training documentation

Who should Attend

• Manufacturing & Production Personnel / Managers
• Anybody who works in a Regulated Environment
• Quality Assurance & Quality Control Personnel / Managers
• Research and Development Personnel (R&D) / Managers
• Validation Specialists
• Laboratory Personnel / Managers
• Project Managers
• Clinical Trial Personnel