21 CFR Part 11, §11.10 and §11.50
21 CFR Part 11, §11.10 and §11.50 (ecfr.gov) (20 min)
In: LABLOOP-W33 Notebook
WEEK 40 · GATE 40: RETRO AND DECISION
Stanford's Designing Your Life course has a simple idea: you do not find your path by thinking harder; you find it by prototyping lives and then choosing among real options. That is what the last 40 weeks were, whether you noticed or not: prototypes of a scientist's life (papers), a consultant's life (audits), and an employee's life (interviews). This week you look at the evidence, not the mood. Gauge level. Income …
THE NEXT BLOCK
21 CFR Part 11, §11.10 and §11.50 (ecfr.gov) (20 min)
In: LABLOOP-W33 Notebook
By Sunday you should be able to say: “I know what I built, what it proved, what people paid for, and where I am going next. It is written down." --- ## PART 8 · The prompt pack (copy, paste, fill the brackets) Use Claude for P1-P2, P5-P10, P12-P15; NotebookLM (sources loaded) for P3-P4 and P16-P18; either for P7, P11, P13. P1 · Kid explainer (study, every Tue/Thu when a concept blocks) Explain [CONCEPT] to me three times. 1. As if I were 10: one everyday object, no jargon, no equations. 2. As if I were a systems engineer with 25 years of experience: what problem it solves, what breaks without it, an analogy from infrastructure (queues, caches, budgets), never from brains. 3. As the textbook would: the equation, every symbol named in one line each, and a tiny worked example with numbers I can redo by hand. Then: one question to check I understood, and wait for my answer. P2 · Concept-to-project bridge (before a build block) I am building [batchlens / fermlit / enzymelens]: [one-sentence description]. Here is what I just studied: [paste notes]. Give me the 3 concrete places where this applies today, ordered by impact over effort. For each: file and function to touch, 10 lines of pseudocode max, the metric that should move, and how I would know I applied it wrong. Skip anything that requires training a model from scratch or new tools. P3 · Socratic quiz (NotebookLM, Sunday or review weeks) Act as [a PI running a lab meeting / a staff ML scientist at a bioprocess-AI company]. Ask me 5 questions of increasing difficulty about [TOPIC], one at a time, waiting for my answer. After each answer, score my rigor 1-5 and say exactly what was missing. Call out vagueness without diplomacy. The last question must be a design case with a cost or data constraint. P4 · Gap detector (NotebookLM, Sunday, 20 min) Below is what I understood this week. Compare it against the sources in this notebook. Return: (1) what I said correctly, one line each; (2) what I said wrong or imprecisely, with the exact quote from the source that corrects me; (3) what I did not mention and should have, ordered by importance; (4) the single thing to revisit on Monday. MY SUMMARY: [paste] P5 · Practice scaffold (turns a lecture into one 90-minute build block) I have 90 minutes, a Python repo [NAME], and this lecture/chapter: [summary or link]. My project needs [the week's build task]. Write me a single-block plan: the one file to create or edit, the function signatures, the test that proves it works, and the "done when" line. No alternatives, no options, no "you could also". If the task does not fit in 90 minutes, cut scope and tell me what you cut. P6 · Staff-engineer code review (Fridays, before release) Review this code as a staff engineer at a scientific-software company who cares about reproducibility. Report only: (1) anything that makes a result non-reproducible (seeds, data leakage across batches, hidden state); (2) anything a reviewer of a paper would flag; (3) the smallest change that fixes each. Ignore style. [paste code or diff] P7 · Annotation guidelines writer (week 6) I am building a gold standard for extracting these fields from fermentation papers: [schema]. Write annotation guidelines: for each field, a one-line definition, the unit and normalization rule, two positive examples and two tricky negative examples (things that look like the field but are not), and what to do when the paper reports a range, several conditions, or nothing. End with a 10-item checklist an annotator runs before saving a paper. P8 · Related-work scout (with verification rule) I am writing a paper on [topic]. List the 15 most relevant prior works you know: title, first author, year, venue, one line on what they did, and one line on how mine differs. Mark each as [SURE] or [VERIFY]. I will check every one on Semantic Scholar before citing; do not invent titles. Then list 5 search queries I should run to find what you might have missed”
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