Good Documentation Practices- GDP 101 Final Quiz

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Question 1 of 10

1. Question
In the context of this course, what does the acronym “GDP” stand for?
- Good Documentation Practice/s
- Gross Domestic Product
- Good Documentation Process
- Greater Declaration Proceeding
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Question 2 of 10

2. Question
Which of the following is NOT an example of GDPs?
- The use of a blue colored pen instead of a pencil.
- A single-line cross out of a blank section of a form with initials and date.
- Blackening incorrect information with a marker.
- Highlighting important test values on a form.
- None of the above.
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Question 3 of 10

3. Question
What ISO 13485:2016 clauses might prevent the use of pencil for quality system records? Select all that apply.
- Clause 4.2.4.
- 21 CFR 820.100.
- Clause 5.4.2.
- Clause 4.2.5.
- Clause 7.2.2.
- Clause 5.2.5.
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Hint

All records are also considered ‘blank’s, but not all ‘blank’s are considered records.
Question 4 of 10

4. Question
From the choices below, what is the best approach for verifying effectiveness of corrective actions related to nonconformities in GDPs?
- Verify that the procedure was updated.
- Verify employees have retraining records.
- Track the frequency of GDP errors as a quality objective.
- Give employees an exam on the new policies.
- None of the above.
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Question 5 of 10

5. Question
True or false, as an authority having jurisdiction, only the U.S. FDA explicitly requires implementation of GDPs?
- True
- False
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Question 6 of 10

6. Question
Which of the following methods is/are acceptable for identifying reviewers and approvers of procedures (check all that apply)?
- Identify the reviewers and approvers within each procedure.
- Provide an approval matrix within your document control procedure.
- Create a separate matrix/procedure for review and approval.
- Indicate within the quality manual that the author shall determine who is responsible for review and approval.
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Question 7 of 10

7. Question
Sub-section 21 CFR 820.40 is specific to document control. What other sub-section would apply more appropriately for good documentation practices regarding quality system records?
- 21 CFR 820.100
- Sub-clause 4.2.4.
- 21 CFR 820.180
- 21 CFR 820.100
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Question 8 of 10

8. Question
Which of the following is a requirement of 21 CFR Part 11?
- The back-up of electronic records.
- The use of unique electronic signatures.
- Audit trails for all changes to records for the period of record retention.
- Software validation.
- All of the above.
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Question 9 of 10

9. Question
True of False, PDF documents are never an acceptable format for electronic records.
- True
- False
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Question 10 of 10

10. Question
Of the choices below, which is the most convenient method for demonstrating training effectiveness?
- Completion of a quiz… like this one.
- Performing an internal audit of the process.
- Signing a training form indicating that the trainee has read and understood the procedure.
- None of the above.
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Exercides Training Courses: 1 – Good Documentation Practices Webinar

Good Documentation Practices- GDP 101 Final Quiz

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