QC reviewer qualification
This eLearning module is to test the ability of QC reviewer to identify errors in the records and improve assurance of the review process
Provide an overview of the review process for GMP data
Revisits the requirement of effective review
Common checks for data review
Role of data reviewers
Assessing the capabilities of the reviewer to identify errors in sample records
Why it matters
Since incorrectly manufactured, or tested medicines, if allowed to reach patients, can cause serious conditions, or even death, various health authorities require a confirmation that, these activities run correctly, during pharmaceutical manufacturing, and testing.
For example, US FDA’s 21 CFR 211.194 have specific requirments for QC data review.
Who is it for
Since production and testing records are the only proof that the activities were carried out correctly, such confirmation takes the form of verification, or review of the records.