Build an evidence-to-authorization decision narrative.
Webinar 3 · The Decision Under Examination · Coming soon
Can the next reviewer reconstruct the decision?
The approval is on file. Someone who was not in the room still has to see why it was reasonable, from the record alone.
When the inspector asks who authorized this and why, this webinar shows what the record must hold.
- Narrated, with captions and a transcript
- One fictional case, worked step by step
- Handouts and a scored knowledge check
What you will be able to do
You will be able to show what an approval proves, and what it leaves for the record to explain.
Tell an evidence-bounded summary from an unsupported one.
Recognize when the record should not yet support approval, and what must happen first.
The method
Four questions an outside reader asks of any decision.
Evidence
What reliable information was available at the decision date?
Judgment
Which approved requirements and reasoning were applied?
Risk
What remained uncertain?
Authorization
Who decided, and under what conditions?
The case you will work
A completed change, satisfactory tests and one unassessed deviation, with approval requested.
Case DR-003 is fictional and deliberately incomplete. A validated packaging-line change went through change control and the post-change tests meet acceptance criteria. One reconciliation deviation sits in the log, not yet assessed, and approval is requested on the words “Testing passed, no material impact.” The question is what the record can honestly say today.
Illustrative, not a substitute for site procedures, Quality Unit authorization or regulatory advice.
While you wait
Preserve the reasoning behind a real decision when it is made.
Inspection Response Record
An existing service for organizing the reasoning behind one consequential GMP decision. It does not independently approve, audit or certify the decision.
$497Start your IRR
Batch Release Authorization Case File
Study one completed, fictional batch-release decision in the form an inspector reads.
The Decision Under Examination
Webinar 1: The Batch Was Reviewed. Was Release Justified? · Webinar 2: A CAPA Is Closed. What Proves It Worked? · All webinars