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 one-day workshop 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 and warning letters for different points presented in the session.
In several occasions, group activities will be presented to find errors in documents based on the information provided in the class.
Why should you Attend: If you are involved in any product manufacturing, knowing GDP regulations is a must for you. It prevents a lot of errors and minimizes the chance of being spotted by the regulatory bodies in their audits.
Areas Covered in the Session:
Definition, Purpose, and Importance
General Rules and Principles of GDP
Requirements of Records
General Tips in GDP
Signature / initial and the meaning
Recording the time and date
Correction of errors
Voiding / cancelling records
Recreating / rewriting records
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)
- 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
• 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