Annex 22 Training – Artificial Intelligence

Description

Our PIC/S & EU Annex 22 training course is now available. Completing this eLearning course (along with Annex 11 and other relevant GMP training topics) will help you & your team stay ahead of Annex 22 (AI) regulatory requirements that apply to computerised systems using Artificial Intelligence (AI) and/or Machine Learning (ML) in GMP/GXP environments.

What does the new PIC/S & EU Annex 22 training course cover?

Annex 22 training (online) covers GMP compliance requirements for computerised systems that use Artificial Intelligence (AI) and/or Machine Learning (ML) technologies.

History & time frames for adoption of the draft PIC/S & EU Annex 22 (AI/ML) guidance?

• In July 2025, a draft version of a new GMP Annex – jointly published via the EU & PIC/S Annex 22 on Artificial Intelligence (AI) & Machine Learning (ML) – was published.
• This new EU & PIC/S Annex represents the first dedicated GMP Annex focused on use of AI & ML in pharmaceutical manufacturing.
• You’ll need to prepare to comply with Annex 22 (AI/ML) before this Annex is finalised in 2026.
• You can learn what’s required for compliance with the new Annex 22 (currently a draft) in this online Annex 22 training course as part of our GMP eLearning topics.

EU & PIC/S Annex 22 Training (Online)

• The new Annex 22 is expected to be finalised/in place in 2026.
• It is important that you and your team prepare to meet these new AI & ML system requirements.
• You should also ensure your operations, computerised systems, and validation documentation meets other key standards, such as Annex 11 (Computerised Systems), ISPE’s GAMP5 (2nd ed), the FDA’s Computer Software Assurance (CSA) requirements, where relevant, and other legal requirements.

Importance of regulatory compliance training in Annex 22 responsibilities:

• Bridge the regulatory gap: Annex 22 fills gaps left by Annex 11 for AI/ML systems.

• Prevent compliance risk: Learn the red flags and audit expectations before you deploy AI & ML in your operations.

• Ensure human accountability & traceability: Implement systems that are auditable, explainable, and controllable.

• Accelerate innovation responsibly: Use AI/ML effectively while staying within GMP boundaries.

Learn more: Complete Annex 22 Training (EU & PIC/S Annex 22 compliance training)

This Annex 22 training course (GMP eLearning) will help you understand the latest regulatory compliance requirements for use of Artificial Intelligence (AI)/Machine Learning (ML) in pharmaceutical manufacturing.

This online GMP course covers regulatory compliance expectations the new EU & PIC/S Annex 22 on Artificial Intelligence & Machine Learning technologies for critical GMP functions.

• PIC/S & EU Annex 22 is currently in draft format.
• It was open to industry feedback through 7 October 2025.
• The new Annex 22 for AI/ML technologies used in GMP processes is expected to be finalised and in effect in 2026.

Get training for PIC/S & EU Annex 22 compliance!

• This course offers learners a GMP Course Certificate following the successful completion of the Final Assessment.
• Available within minutes of ordering, and available 24/7 for 12 months from date of purchase or Assignment. Internet access required.
• One learner per licence.

EU & PIC/S Annex 22 – Artificial Intelligence

Annex 22 requirements (currently in draft format) are expected to be finalised and in force in 2026.

Why complete this online course covering Annex 22 (Artificial Intelligence) GMP requirements:

It’s important to stay up-to-date with these new regulations because these will have major implications on how you manage computerised systems relying on Artificial Intelligence including Machine Learning technologies.

Completing this course will help you prepare for the new GMP compliance requirements for use of AI and/or ML in pharmaceutical manufacturing.

• You’ll gain the knowledge you need to prepare to comply with the new requirements in Annex 22.
• These AI & ML GMP compliance requirements do not replace Annex 11 (Computerised Systems).
• They describe specific GMP requirements and risk management standards for deploying AI and ML technologies in critical GMP functions/processes.

What you will learn

Topics in this EU & PIC/S Annex 22 – Artificial Intelligence eLearning Course include:

• Scope and applicability of Annex 22: which AI/ML models it covers and when human oversight is mandatory.
• Core principles and governance including risk-management approaches to AI & ML technologies

• Data integrity and AI

• Personnel training requirements

• Validation, test datasets, testing independence

• Audit trails, access control, and drift control.

• Validation and test execution

• Acceptance criteria, performance metrics and more

Add this item to your cart and complete your purchase (or buy the bundle of all PIC/S Annexes) and start your GMP training today!

One learner per licence.
Access this course online for 12 months from date of purchase.
This includes any course updates if changes to this draft Annex 22 before finalisation.