Data Integrity Awareness: Good Documentation Practices


Upon completion of this course, you will be able to explain the following concepts related to good documentation practices (GDP), key reasons for maintaining GDP, GDP the FDA, Eudralex, and WHO, documents within the scope of GDP, general rules of GDP, GDP and ALCOA+ and GDP best practices.

Curriculum for this course:
Program Introduction
Course Introduction 1 min 01 secs
Learning Objectives 1 min 30 secs
Overview: Data Integrity Awareness 1 min 21 secs
Who Should Take This Program? 1 min 25 secs
What are the Key Reasons for Maintaining Good Documentation?
What are the Key Reasons for Maintaining Good Documentation? 1 min 05 sec
The Regulators: FDA/Eudralex/WHO 1 min 10 secs
Documents within the Scope of GDP 1 min 08 secs
GDP Example: Zhejiang Hisun Pharmaceutical Co. FDA Warning Letter 1 min 17 secs
The General Rules of GDP
GDP: Attributable (Signatures) 1 min 20 secs
GDP: Legible (Clear, Complete, Legible) 1 min 50 secs
GDP: Contemporaneous (Time of Occurrence) 1 min 02 secs
GDP: Original (First capture) 1 min 25 secs
GDP: Accurate (Data is Correct) 1 min 10 secs
Controlled Documents
Date Format 1 min 10 secs
Time Format 1 min 15 secs
Signatures 1 min 05 secs
Language – Correct Grammar 1 min 22 secs
Use Indelible Ink 1 min 18 secs
Scrap Paper and Post-Its 1 min 07 secs
Transcribing 1 min 04 secs
Late Entries 1 min 03 secs
Corrections 1 min 25 secs
Corrections – Example 1 1 min 28 secs
Corrections – Example 2 1 min 32 secs
Blank Fields 1 min 08 secs
Additional Pages / Attachments 1 min 01 secs
Instrument Printouts 1 min 11 secs
Logbooks 1 min 14 secs
Interactive Scenario 1 min 19 secs
Final Assessment

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