FDA Part 11 Scope and Application guidance
Tuesday · after 21 CFR Part 11, §11.10 and §11.50
FDA Part 11 Scope and Application guidance (2003), sections III-IV (25 min)
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In: LABLOOP-W33 Notebook
WEEK 30 · AUDIT DELIVERY 2; PAPER 3 RESULTS
Do one thing.
Then you are ahead.
Two deliveries meet this week, and they rhyme. For the client, you close the audit with a readout and an anonymised case study (with permission). For the partner, you open the envelope: the wet-lab results for your candidates, analysed exactly as pre-registered in week 24. Small numbers of samples need special care: with three replicates, one outlier can create or destroy a "finding". Think of a restaurant with thre…
If you only do one thing this week: the pre-registered analysis run
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THE NEXT BLOCK
How long have you got?
By Sunday you should be able to say: “I can show whether my predictions held in a real lab, with every replicate visible, and I delivered a client readout the same week.”
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MOMENTUM
What you have actually done
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