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Building Modern Pharma Manufacturing Execution and AI Integration (MES + GxP + EU Annex 22 + PIC/S + Data Integrity + AI Quality + Regulator Engagement)

$199.00
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A focused course, tailored for you

Building Modern Pharma Manufacturing Execution and AI Integration (MES + GxP + EU Annex 22 + PIC/S + Data Integrity + AI Quality + Regulator Engagement)

Build the modern pharma manufacturing execution and AI integration capability in 10 weeks. MES + GxP + EU Annex 22 + PIC/S + data integrity + AI quality + regulator engagement.

Pharma manufacturers face MES modernisation pressure, GxP compliance under tightening data-integrity expectations, EU Annex 22 AI integration, PIC/S harmonisation, AI quality applications, and regulator engagement complexity. Engineers who build the integrated capability take the senior manufacturing work. Here is the 10-week build.

$199 one-time
Tailored to your situation. Access within 24 hours. 30-day money-back.

Includes a hand-built implementation playbook delivered alongside course access, generated for your specific situation.

Why this course

Pharma manufacturers (Merck KGaA / EMD Group, Bayer, Roche, Novartis, Sanofi, GSK, AstraZeneca, Pfizer, Johnson & Johnson, Lilly, Bristol-Myers Squibb, AbbVie, Amgen, Gilead, Vertex, Biogen, Regeneron, Moderna, BioNTech, CureVac, Recursion, Insmed, Alnylam, Vertex, Intellia, Editas, Beam Therapeutics, Verve Therapeutics, Vertex, Cellectis, Affimed, BeiGene, Daiichi Sankyo, Takeda, Eisai, Otsuka, Astellas, Mitsubishi Tanabe, Kyowa Kirin, Shionogi, Hisamitsu, Sumitomo Pharma, Chugai, ONO Pharmaceutical, JCR Pharmaceuticals, JT Pharmaceuticals, Kobayashi, Nichi-Iko, Sawai, Towa, Nippon Shinyaku, Mochida) face MES (Manufacturing Execution System) modernisation pressure in 2024-2026.

GxP compliance under tightening data-integrity expectations (FDA ALCOA+ principles, EU GMP Annex 11 update, PIC/S PI 041 data integrity guidance, WHO data integrity guidance), EU Annex 22 (the new draft AI in GMP annex) under public consultation through 2025 with effective-from possible 2027, PIC/S harmonisation across jurisdictions, AI quality applications (AI for in-process quality monitoring, AI for batch-release decision support, AI for OOS investigation, AI for deviation root-cause analysis, AI for change-control impact assessment, AI for trending, AI for forecasting, AI for predictive maintenance, AI for production scheduling, AI for warehouse management, AI for cold-chain monitoring), regulator engagement complexity (FDA, EMA, PMDA Japan, NMPA China, MFDS Korea, TGA Australia, CDSCO India, ANVISA Brazil, COFEPRIS Mexico, EU member state regulators, Health Canada, MHRA UK, SwissMedic), continuous manufacturing transition where applicable, ATMP (Advanced Therapy Medicinal Products) and gene therapy specific GMP, and supply-chain transparency under Drug Quality and Security Act (DSCSA, fully effective 2025) and EU Falsified Medicines Directive (FMD) all need to land at the engineering layer.

Engineers who build the integrated capability take the senior manufacturing work. Engineers who stay on classic MES-only patterns watch the senior work shift to peers.

This course teaches the 10-week build of modern pharma manufacturing execution and AI integration: MES architecture, GxP compliance framework, EU Annex 22 framework, PIC/S harmonisation framework, data integrity framework, AI quality framework, regulator engagement framework, and the executive engagement model. Twelve modules with deliverables. Plus a hand-built implementation playbook for your specific operation.

What you walk away with

  • A documented MES architecture.
  • A GxP compliance framework.
  • An EU Annex 22 framework.
  • A PIC/S harmonisation framework.
  • A data integrity framework.
  • An AI quality framework.
  • A regulator engagement framework.
  • An executive engagement model.
  • A 10-week build plan.

The 12 modules

Module 1. Pharma manufacturing landscape 2026
Detailed walkthrough of the pharma manufacturing landscape in 2026: MES vendor landscape (Werum PAS-X by Körber, Siemens Opcenter Execution Pharma, Rockwell PharmaSuite, Honeywell Forge, AVEVA MES, EMERSON DeltaV Pharma, in-house), peer-manufacturer positioning at Merck KGaA + Bayer + Roche + Novartis + Sanofi + GSK + AstraZeneca + Pfizer + Johnson & Johnson + Lilly + Bristol-Myers Squibb + AbbVie + Amgen + Gilead + Vertex + Biogen + Regeneron + Moderna + BioNTech + CureVac + Recursion + Insmed + Alnylam + Intellia + Editas + Beam Therapeutics + Verve Therapeutics + BeiGene + Daiichi Sankyo + Takeda + Eisai + Otsuka + Astellas + Mitsubishi Tanabe + Kyowa Kirin + Shionogi + Sumitomo Pharma + Chugai + ONO Pharmaceutical, AI landscape, regulatory landscape (FDA ALCOA+, EU GMP Annex 11, EU Annex 22 draft, PIC/S PI 041, WHO data integrity, DSCSA, EU FMD, PMDA Japan, NMPA China), and the strategic-level decisions facing engineers.
Module 2. MES architecture framework
Build the MES architecture framework: MES core selection, electronic batch records (eBR) framework, recipe management framework, weigh and dispense framework, in-process control integration framework, equipment-and-utility integration framework, ERP-integration framework (SAP S/4HANA Pharma, Oracle JD Edwards, in-house), and the integration with broader operations technology stack. Three MES architecture patterns at peer manufacturers.
Module 3. GxP compliance framework
Build the GxP compliance framework: GMP-compliance framework (21 CFR 211, EU GMP, PIC/S, WHO TRS 1019), GLP-compliance framework where applicable, GCP-compliance framework where applicable, GDP-compliance framework, GVP-compliance framework where applicable, computer-system validation framework (GAMP 5 Second Edition), and the integration with broader QA.
Module 4. EU Annex 22 framework
Build the EU Annex 22 framework: EU Annex 22 (the new draft AI in GMP annex) tracking framework, AI in GMP scope framework, AI lifecycle management framework, AI risk assessment framework, AI validation framework, AI continuous-monitoring framework, AI explainability framework, AI change-management framework, and the integration with broader GxP compliance. The framework that prepares the operation for Annex 22 effective.
Module 5. PIC/S harmonisation framework
Build the PIC/S harmonisation framework: PIC/S membership status across regulators, PIC/S PI 041 data integrity guidance integration, PIC/S PI 042 computerised systems integration, PIC/S PI 023 ATMP guidance integration, PIC/S inspection harmonisation framework, and the integration with broader regulatory harmonisation.
Module 6. Data integrity framework
Build the data integrity framework: ALCOA+ principles framework (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available), electronic-record framework (FDA 21 CFR Part 11, EU GMP Annex 11), audit-trail framework, exception-management framework, data-lifecycle framework, and the integration with broader compliance.
Module 7. AI quality framework
Build the AI quality framework: AI for in-process quality monitoring framework, AI for batch-release decision support framework, AI for OOS (out of specification) investigation framework, AI for deviation root-cause analysis framework, AI for change-control impact assessment framework, AI for trending framework, AI for forecasting framework, AI for predictive maintenance framework, AI for production scheduling framework, AI for warehouse management framework, AI for cold-chain monitoring framework, and the integration with broader AI strategy.
Module 8. Regulator engagement framework
Build the regulator engagement framework: FDA engagement framework, EMA engagement framework, PMDA Japan engagement framework, NMPA China engagement framework, MFDS Korea engagement framework, TGA Australia engagement framework, CDSCO India engagement framework, ANVISA Brazil engagement framework, COFEPRIS Mexico engagement framework, Health Canada engagement framework, MHRA UK engagement framework, SwissMedic engagement framework, and the integration with broader regulatory affairs.
Module 9. Advanced therapy and continuous manufacturing
Build the advanced therapy and continuous manufacturing framework: ATMP-specific GMP framework, gene therapy-specific GMP framework, cell therapy-specific GMP framework, mRNA-specific GMP framework, continuous manufacturing framework, real-time release testing framework, and the integration with broader manufacturing strategy.
Module 10. Supply-chain transparency framework
Build the supply-chain transparency framework: DSCSA (Drug Supply Chain Security Act) compliance, EU FMD (Falsified Medicines Directive) compliance, serialisation framework, track-and-trace framework, EPCIS framework, and the integration with broader supply-chain strategy.
Module 11. Executive and board engagement
Build the executive and board engagement: CTO partnership, COO partnership, CQO (Chief Quality Officer) partnership, CRO partnership, CCO partnership, board-of-directors quality-committee engagement, and the integration with broader executive cadence.
Module 12. Your 10-week build plan
Week-by-week plan with weekly deliverables. Weeks 1-2: pharma manufacturing landscape + MES architecture framework. Weeks 3-4: GxP compliance framework + EU Annex 22 framework. Weeks 5-6: PIC/S harmonisation framework + data integrity framework. Weeks 7-8: AI quality framework + regulator engagement framework. Weeks 9-10: advanced therapy and continuous manufacturing + supply-chain transparency + executive engagement. Deliverable: modern pharma manufacturing execution and AI integration capability.

How this addresses your situation

Specific modules that map to what you said you are dealing with.

Module 1 covers the landscape.
Module 2 produces MES architecture.
Module 3 covers GxP compliance.
Module 4 covers EU Annex 22.
Module 5 covers PIC/S harmonisation.
Module 6 covers data integrity.
Module 7 covers AI quality.
Module 8 covers regulator engagement.
Module 9 covers advanced therapy and continuous manufacturing.
Module 10 covers supply-chain transparency.
Module 11 covers executive engagement.
Module 12 covers the 10-week build plan.

What you get with this course

  • The 12-module course delivered as text plus downloadable templates.
  • Templates and worked examples for MES architecture framework, GxP compliance framework, EU Annex 22 framework, PIC/S harmonisation framework, data integrity framework, AI quality framework, regulator engagement framework, advanced therapy and continuous manufacturing, supply-chain transparency, executive and board engagement.
  • A hand-built implementation playbook generated for your specific operation.
  • Three worked examples of modern pharma manufacturing execution and AI integration capabilities at peer manufacturers.
  • Scripted talking points for the CQO and regulator engagement.

What you will have in hand by Day 1, Week 1, Month 1

Day 1: MES architecture scaffold drafted.

Week 4: GxP compliance + EU Annex 22 designed.

Week 8: PIC/S + data integrity + AI quality + regulator engagement operational.

Week 10: Capability in operation.

Before and after

Before

Your manufacturing practice handles classic MES-only patterns. GxP compliance under tightening data-integrity expectations strains the operation. EU Annex 22 preparation is reactive. AI quality applications are talked about but not deployed. Senior manufacturing work goes to peers shipping the integrated capability.

After

A modern pharma manufacturing execution and AI integration capability is in operation. MES architecture framework, GxP compliance framework, EU Annex 22 framework, PIC/S harmonisation framework, data integrity framework, AI quality framework, regulator engagement framework, advanced therapy and continuous manufacturing, supply-chain transparency, executive and board engagement are all designed.

What happens if you do not address this

Engineers without the integrated capability miss senior manufacturing work. EU Annex 22 effective possibly 2027; DSCSA fully effective 2025; FDA ALCOA+ expectations tighten; AI in GMP is a forcing event.

Who it is for

For pharma manufacturing engineers, MES leads, quality leaders, automation engineers, validation engineers, and senior manufacturing leaders at pharma manufacturers and pharma-CDMO firms.

Who this is NOT for. Pure clinical-trial roles without manufacturing scope. Engineers at firms with no pharma manufacturing business. Pure regulatory-affairs roles without engineering scope.

How it arrives

Text-based course via LMS, plus downloadable templates and worked examples and the hand-built implementation playbook.

Time investment. Roughly 18 hours of reading and 200 to 400 hours of engineering effort across the 10-week build.

Why $199 is the right number

External pharma manufacturing consultants (Big4 life-sciences practices like the firm Life Sciences, the firm Life Sciences, the firm Life Sciences, the firm Life Sciences, specialist firms like McKinsey Pharma, BCG Pharma, Bain Pharma, the firm Life Sciences, the firm Engineering Life Sciences, the firm Life Sciences, IQVIA, ICON, Parexel) charge $500K-$3M for manufacturing modernisation programmes. MES-platform-implementation programmes (Werum PAS-X, Siemens Opcenter Pharma, Rockwell PharmaSuite) run $5M-$50M total. $199 buys the focused playbook plus the implementation document for your specific operation.

FAQ

Will this replace hiring a pharma-manufacturing consultant?
Partially. It teaches the integrated capability. You may still want specialist input for complex EU Annex 22 transition.
What if my operation is primarily small-molecule (not biologics)?
Modules 2, 6, and 9 cover small-molecule-anchored patterns.
Does this cover sterile-fill-finish manufacturing specifically?
Module 6 covers sterile-fill-finish patterns.
What about CDMO operations specifically?
Modules 1 and 11 cover CDMO patterns.
What is in the implementation playbook for me specifically?
MES architecture tailored to your specific operation; AI quality framework matched to your specific product line; a 10-week build plan.

30-day money-back guarantee. If after a week of working through the materials this is not what you needed, reply to the receipt email and a full refund is processed. No questions, no forms.

Within 24 hours your account in the learning environment is provisioned and the tailored implementation playbook is delivered alongside it.

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