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.
Agenda
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
