2019 - Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

The outline of this training 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
General Tips for Laboratory Notebook Documentation:
Assignment of Lab notebook
How to properly document in lab notebooks
How to include tables / graphs
How to attach instrument print outs
How to include metadata
How to reference lab notebook
How to store the completed lab notebooks
US Pharmacopoeia General Chapter <1029>
Rules Governing Medicinal Products in the European Union (Vol. 4: Documentation)
What is new in the Latest Version?
Outline of EU GDP Regulations
GDP Enforcement (examples from FDA warning letters)