Course

Validate AI in GMP Quality: Build Your Five-Document Case

Nikhil Pal

Pharma quality and OpEx practitioner

Your quality unit will be asked to approve AI. Build the case it can challenge.

Most quality teams are now being asked to approve an AI tool. The vendor has a demo, the business has a deadline, and the quality unit has a question nobody has answered yet: what evidence is enough?

This cohort answers that question for one use case: yours. Over four weeks you build five documents, one after the other: a use-case scorecard, an intended-use statement, an AI risk assessment, an assurance and test plan, and a 90-day pilot roadmap. One sentence travels through all five: your criticality position.

After each submission I review your documents and send written feedback: whether the five documents agree with each other, which positions would hold up when your quality unit challenges them, and the one fix that matters most before next week.

There are no live sessions. You watch the lectures in your own time, about two hours a week, and submit one piece of work each week. Nothing in this cohort can make a site compliant or inspection-ready, and the feedback does not claim to.

What you’ll learn

Go from being asked to approve an AI tool to holding five documents that justify your answer.

  • Score candidates on value, feasibility, GMP impact and data readiness

  • Write the criticality position that every later document carries

  • Define the task, the range of inputs, the limits and the operator's role

  • Split the inputs into subgroups that will expose weak spots

  • Combine model influence and decision consequence into model risk

  • Write down every mitigation, so the rating holds when it is challenged

  • Set acceptance criteria per input subgroup, tied to a measured baseline

  • Design the human review step when the model drafts text: who reviews, what they check, what they record

  • Set pilot, controlled-use and routine-use gates with the evidence needed at each

  • Name who owns the stop decision, and treat stopping at a gate as a valid result

Learn directly from Nikhil

Nikhil Pal

Nikhil Pal

Contact

LSS Master Black Belt · Prosci-certified · Author, BPI in the Age of AI

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Who this course is for

  • QA and quality systems professionals who are being asked to approve AI tools and want a method they can defend.

  • CSV and CSA practitioners who need an assurance approach for systems that contain a trained model.

  • Manufacturing, MSAT, QC and digital leads who want their AI pilot to pass the quality gate the first time.

Prerequisites

  • Working knowledge of GMP

    You work in or alongside QA, validation, manufacturing or QC. No programming or data science needed.

What's included

Nikhil Pal

Live sessions

Learn directly from Nikhil Pal in a real-time, interactive format.

Lifetime access

Go back to course content and recordings whenever you need to.

Community of peers

Stay accountable and share insights with like-minded professionals.

Certificate of completion

Share your new skills with your employer or on LinkedIn.

Written feedback on every submission

Four reviews of your own documents from Nikhil, each within three working days.

13 editable templates

Word, Excel and PowerPoint files you keep and reuse for your next use case.

62 recorded lectures with captions

About two hours a week, watched in your own time. No live sessions to attend.

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Reimbursement

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Everything L&D needs: email template, receipts, and certificate of completion.

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Private cohort

Run a cohort for your org

A dedicated cohort with a custom schedule and curriculum, tailored to your team.

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