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In the context of this course, what does the acronym “GDP” stand for?
Which of the following is NOT an example of GDPs?
What ISO 13485:2016 clauses might prevent the use of pencil for quality system records? Select all that apply.
All records are also considered ‘blank’s, but not all ‘blank’s are considered records.
From the choices below, what is the best approach for verifying effectiveness of corrective actions related to nonconformities in GDPs?
True or false, as an authority having jurisdiction, only the U.S. FDA explicitly requires implementation of GDPs?
Which of the following methods is/are acceptable for identifying reviewers and approvers of procedures (check all that apply)?
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?
Which of the following is a requirement of 21 CFR Part 11?
True of False, PDF documents are never an acceptable format for electronic records.
Of the choices below, which is the most convenient method for demonstrating training effectiveness?