Good Documentation Practice and Record Keeping Regulations (FDA & EMA) 2018

Good Documentation Practice and Record Keeping Regulations (FDA & EMA) 2018 is a webinar dedicated to general rules and principles of GDP which applies to laboratory notebook documentation, US Pharmacopeia General Chapter.

Topics

• General Rules and Principles of GDP
  • General Tips in GDP:
  • Requirements of Records
  • General Tips for Laboratory Notebook Documentation:
• Definition, Purpose, and Importance
• Rules Governing Medicinal Products in the European Union (Vol. 4: Documentation)
  • Outline of EU GDP Regulations
  • What is new in the Latest Version?
• US Pharmacopoeia General Chapter 1029
• GDP Enforcement (examples from FDA warning letters)

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