Good Documentation Practices (GDocP) and Data Integrity
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
Certification
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