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2019 - Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
Date2019-09-19
Deadline2019-09-19
VenueOnline Event, USA - United States 
KeywordsGDP; Good Documentation Practice; Record Keeping
Topics/Call fo Papers
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
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)
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
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)
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Last modified: 2019-08-21 17:26:28