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

  • Webinar
  • 60 Minutes
  • March 2019
  • World Compliance Seminar
  • ID: 4755578
Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified. This 60-min Webinar covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules and principles of GDP (US & EU), General tips for Laboratory Notebook documentation and finally discussing GDP enforcement by regulatory bodies in different countries with some examples of FDA citations.


Following the completion of this On-Demand Webinar you will gain a basic to moderate knowledge of definition, purpose, importance of GDP, General rules of GDP, GDP as applies to laboratory notebook documentation, US Pharmacopeia General Chapter introduction “Good Documentation Guidelines”, A very brief introduction to European Union (EU) GDP, and finally its enforcement along with some observation samples from FDA. The outline of this 90 minute On-Demand Webinar includes:
  • Definition, Purpose, and Importance
  • General Rules and Principles of GDP
  • Requirements of Records
  • General Tips in GDP:
  • Signature / initial and the meaning
  • Copying records
  • Document maintenance
  • Recording the time and date
  • Correction of errors
  • Rounding rules
  • Back dating
  • Missing data
  • Voiding / cancelling records
  • Recreating / rewriting records
  • Deviations
  • Rules Governing Medicinal Products in the European Union (Vol. 4: Documentation)
  • What is new in the Latest Version?
  • GDP Enforcement (examples from FDA warning letters)

Who Should Attend

  • Anybody who works in a regulated environment
  • Manufacturing & Production Personnel/Managers
  • Research and Development Personnel (R&D)/Managers
  • Quality Assurance & Quality Control Personnel/Managers
  • Laboratory Personnel/Managers
  • Validation Specialists
  • Clinical trial personnel
  • Project Managers