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.
Good Documentation Practice and Record Keeping Regulations (FDA & EMA) 2018 covers topics such as:
- 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)
Good Documentation Practice and Record Keeping Regulations (FDA & EMA) 2018 is intended for:
- 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
