Topics
General Rules and Principles of GDP::
- General Tips in GDP
- Requirements of Records
- Copying records
- Signature / initial and the meaning
- Recording the time and date
- Document maintenance
- Rounding rules
- Correction of errors
- Missing data
- Back dating
- Recreating / rewriting records
- Voiding / cancelling records
- Deviations
, Definition, Purpose, and Importance:: and Rules Governing Medicinal Products in the European Union (Vol. 4: Documentation)::
- GDP Enforcement (examples from FDA warning letters)
- What is new in the Latest Version?
Who should Attend
- Research and Development Personnel (R&D) / Managers
- Manufacturing & Production Personnel / Managers
- Laboratory Personnel / Managers
- Quality Assurance & Quality Control Personnel / Managers
- Validation Specialists
