CEU Credits: 0.1
Course Code: ELM-153
Duration: 40 min
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.2
Effective Date: 08/13/2021
Curriculum for this course
Course Introduction
Learning Objectives
Overview: Data Integrity Awareness
Who Should Take This Program?
What are the Key Reasons for Maintaining Good Documentation?
The Regulators: FDA/Eudralex/WHO
Documents within the Scope of GDP
GDP Example: Zhejiang Hisun Pharmaceutical Co. FDA Warning Letter
GDP: Attributable (Signatures)
GDP: Legible (Clear, Complete, Legible)
GDP: Contemporaneous (Time of Occurrence)
GDP: Original (First capture)
GDP: Accurate (Data is Correct)
Date Format
Time Format
Signatures
Language – Correct Grammar
Use Indelible Ink
Scrap Paper and Post-Its
Transcribing
Late Entries
Corrections
Corrections – Example 1
Corrections – Example 2
Blank Fields
Additional Pages / Attachments
Instrument Printouts
Logbooks
Interactive Scenario
Conclusion
Final Assessment
Certification
Minor update: Updated resource links and ensured resources tab is accessible throughout the course. Removed malfunctioning interactive scenario slide.
V1.2
