Data Integrity & Good Documentation Practices (GDocP)

Description:

This course has been designed to help you understand Good Documentation Practices in the light of Data Integrity requirements. Despite numerous regulatory guidelines poor documentation practice has become more and more a global problem and in most cases, it leads to severe violations of data integrity principles. By completing this online training course, you will versed in all aspect of GDocP in a regulated manufacturing environment.

Curriculum for this course:
Introduction
Overview 50 secs
Learning objectives 25 secs
Who should take this course? 1 min 04 secs
Course modules 1 min 30 secs
Module 1: The Starting Line
Overview 26 secs
What are Good Documentation Practices (GDocP)? 52 secs
Examples 37 secs
Entire document life cycle 56 secs
Create a SOP 32 secs
Benefits of GDocP 08 secs
Module 2: General Rules
Overview 1 min
Document Types 54 secs
Fundamentals of Good Documentation Practices – Part 1 1 min 50 secs
Fundamentals of Good Documentation Practices – Part 2 1 min 45 secs
Signatures 45 secs
Document control 1 min 39 secs
Minimum number of approvers 1 min 20 secs
Never back date! 56 secs
Specimen file 1 min 01 secs
Electronic systems 1 min 30 secs
Date and time format 1 min 40 secs
Good practice 39 secs
Be consistent 1 min 30 secs
Format 2 min 30 secs
Languages – Correct grammar 1 min 40 secs
Use indelible ink 50 secs
Do not 30 secs
Blue of black 25 secs
Scrap paper and post-its 1 min 30 secs
Transcribing 45 secs
Late Entries 52 secs
Blank fields 1 min
Annotations 1 min 23 secs
Additional pages 49 secs
Instrument print-outs 1 min 23 secs
Ditto 25 secs
Module 3: Corrections
Overview 58 secs
Making corrections 41 secs
Draw a Line 55 secs
Explanation codes 1 min 02 secs
Correction tape & fluid 44 secs
Explanations for the correction 39 secs
Verification 56 secs
Multiple corrections 41 secs
Avoid asterisks 21 secs
Review activity 5 mins
Module 4: Logbooks
Overview 40 secs
Elements of a Logbook 1 min 02 secs
Supporting Procedures 58 secs
Keep On-Site 1 min 23 secs
Data entering ground rules 1 min 50 secs
Reviewing recorded data 1 min 31 secs
Examples 50 secs
Retrieving logbooks 1 min 23 secs
Logbook auditing 49 secs
Signature blocks 1 min 20 secs
Page numbering 56 secs
Avoid gaps 1 min 52 secs
Attachments and print-outs 1 min 30 secs
Module 5: General Test Results
Overview 50 secs
Protocol Generation 32 secs
Protocol Execution Tips 47 secs
Variable Data 32 secs
Errors Can Be Costly 2 mins
Expected Results 16 secs
Calculations & Formula 1 min 05 secs
Oops & Uh-Ohs 1 min 48 secs
Accountability 1 min 12 secs
Rules of Thumb 21 secs
Units of Measurement 1 min 19 secs
Attachment -Reminder 1 min 17 secs
Legal Factors 1 min 19 secs
Review activity 5 mins
Conclusion
Final assessment
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