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AI for Biopharma Manufacturing

A two-day AI course for GMP professionals in pharma manufacturing.

The flagship course. Two days of scored exercises built on real pharma manufacturing scenarios, delivered with NIBRT in Dublin.

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Delivered with NIBRT in Dublin since June 2026.

Length
Two days
Delivery
In person, instructor-led, trainees in pairs on shared iPads
Exercises
12
Status
Delivered with NIBRT

What you practise.

  1. Your first AI conversation

    An open conversation with an AI persona about where AI fits on a biopharma site. No decision and no mark shown to the pair; it records where each pair starts.

  2. Predictive maintenance: bearing vibration analysis

    Race the AI. Call a pump bearing's condition from its vibration data, then see the model's call and what each choice would cost.

  3. Bioreactor pH excursion: root cause investigation

    At the bioreactor in the Upstream suite, read an AI agent's investigation step by step, challenge its evidence and make the call.

  4. Right-size the validation: GAMP and AI

    Decide how much validation an AI use actually needs, put a cost on it and defend the plan to a validation lead.

  5. Classify the AI use case: Annex 22

    Classify an AI use under the draft Annex 22, then see the records that classification would make you keep.

  6. Lock the acceptance criteria, then hold the line

    Write down the numbers you will hold an AI to. When the test result just misses them, edit the threshold or raise a deviation.

  7. CPP to CQA mapping with AI

    Work through a correlation summary of fifty batches with an AI persona to find which process parameters drive quality.

  8. Column lifetime prediction: replace it now?

    At the chromatography skid in the Downstream suite, weigh a lifetime prediction and decide whether to replace the column.

  9. In-process control drift: stop the fill line?

    On the fill line, an AI agent flags drift in in-process controls. Stop the line or let it run, and say why.

  10. Batch record exception triage

    An AI has pre-triaged a batch record's exceptions. Decide which of its calls earned your agreement.

  11. Audit trail review: data integrity red flags

    Judge an AI's audit trail review against ALCOA+, where a harmless oddity and a data integrity red flag look alike until you read closely.

  12. Your 90-day AI roadmap

    Design an AI pilot for your own site, score it on readiness, risk, impact and feasibility, and pitch it to the room in two minutes.

Day one is AI literacy, then governance. Day two is data, judgement and your own pilot. Three exercises run in NIBRT’s manufacturing suites: S3 in Upstream, S8 in Downstream and S9 in Fill-Finish.

The two days, hour by hour.

Both days start at 09:00 and finish at about 16:20. Times are the planned run and move a little with the room.

Day one: AI literacy, then governance.

  1. 09:00 Welcome, why now, and signing in on the iPads
  2. 09:25 What a language model is, shown live
  3. 09:43 S1, your first AI conversation, and debrief
  4. 10:13 Four kinds of AI, and the four moves the course repeats
  5. 10:25 Break
  6. 10:40 S2, predictive maintenance, and debrief
  7. 11:03 What an agent is, shown live, then gown up
  8. 11:23 S3, bioreactor pH excursion, at the bioreactor Upstream suite
  9. 12:08 Walk back and debrief
  10. 12:23 Lunch
  11. 13:08 Validation: what applies to you, and when
  12. 13:38 S4, right-size the validation, and debrief
  13. 14:28 Break
  14. 14:43 Annex 22, and the records it would make you keep
  15. 15:01 S5, classify the use case, and debrief
  16. 15:36 S6, lock the acceptance criteria, and debrief
  17. 16:11 Close of day one

Day two: Data, judgement and your own pilot.

  1. 09:00 Recap
  2. 09:10 S7, CPP to CQA mapping, and debrief
  3. 09:40 AI on a spreadsheet, a dashboard and your own files, shown live
  4. 10:05 Break
  5. 10:20 Gown up and walk to the Downstream suite
  6. 10:30 S8, column lifetime, at the skid Downstream suite
  7. 11:10 Two ways to spot drift, then walk to Fill-Finish
  8. 11:25 S9, in-process control drift, on the fill line Fill-Finish suite
  9. 12:10 Lunch
  10. 12:55 S10, batch record exception triage, and debrief
  11. 13:50 Break
  12. 14:00 S11, audit trail review, and debrief
  13. 14:40 Break
  14. 14:50 S12, your 90-day roadmap
  15. 15:25 Pitches, two minutes per pair
  16. 16:00 Who owns this at your site, and certificates

Who should attend.

  • MSAT
  • QA
  • QC
  • Engineering
  • Process development
  • Tech transfer
  • Operations
  • Data

What you leave with.

  • A co-branded certificate
  • A full course record of every decision and score
  • An alumni code to keep practising for 12 months
See the certificate and course record

Delivery and dates.

Public cohorts run at NIBRT in Dublin. The next is on 7 and 8 December 2026. Book a place on NIBRT's course page.

For a cohort at your own site or on your institute's instance, book a demo and we will plan it with you.

For manufacturing sites Read the evidence

Questions about this course.

Do trainees need to know anything about AI before the course?

No. Most trainees on the flagship course have never had a conversation with an AI model before the first exercise, so that exercise is an open conversation with no mark. The course starts from the work trainees already do.

Does it work without a GMP suite?

Yes. The course runs in an ordinary classroom, and a physical GMP suite is not required.

What does each trainee leave with?

A co-branded certificate, a full course record of their decisions and scores, and an alumni code to keep practising on their own device for 12 months.

Does the course certify EU AI Act compliance?

No. No course can certify EU AI Act compliance, and we do not claim to. The course builds the practical AI literacy that Article 4 of the Act asks organisations to ensure in their staff.

Bring one cohort. See the record they leave with.

Book a demo

A 30-minute call with the engineers who built it. No slides.