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2020 - Good Documentation Practice and Record Keeping Regulations (FDA & EMA)



VenueOnline event, USA - United States USA - United States

KeywordsGDP; Good Documentation Practice; Record Keeping


Topics/Call fo Papers

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
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)

Last modified: 2020-06-30 22:15:15