ONLINE COURSE

Introduction to AI in regulated environments

Learn how to tackle the use of Artificial Intelligence systems in GxP contexts!

What will you learn?

✔ Understand why AI systems require their own validation framework beyond GAMP 5

✔ Classify any AI system according to the three axes of the guide: model type, behavior, and level of autonomy

✔ Identify the specific risks that AI introduces in GxP environments and the roles needed to manage them

✔ Manage the data lifecycle as a regulated component of the system: acquisition, integrity, split, and monitoring

✔ Apply the model lifecycle according to the guide: MRS, controlled training, Model Testing, and formal deployment

✔ Implement an operation monitoring plan and manage changes in AI systems

✔ Assess the maturity level of an AI system using the concepts of autonomy and adaptability

✔ Understand the responsibilities the guide assigns to the regulated company and the provider, and apply the Science-based QRM approach

ONLINE

4 hours

300€

per person

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Content
Target audience
Details
Discounts

Content
- Module 1 Introduction and Scope
- Module 2 System Classification
- Module 3 Risks and Roles
- Module 4 Data Lifecycle
- Module 5 Model Lifecycle
- Module 6 Operation, Monitoring, and Change
- Module 7 AI Maturity
- Module 8 Responsibilities and QRM
Target audience
- - Quality, Validation, and Compliance Professionals
  - IT and digital systems managers in the pharmaceutical and medical device industries
  - Life Sciences consultants and managers involved in AI projects
  - Validation teams that need to evaluate, qualify, or audit systems with AI components
  - Data Scientists and technical profiles working in regulated environments who need to understand the GxP requirements of their models
Details
Timetable: flexible, you set the pace.
Accessibility: available 24/7 for 30 calendar days.
Language: Spanish

Included materials:
- Evaluation test
- PDF training presentation
- Certificate of attendance (downloadable from the platform)
Payment by Bank Transfer: if you prefer to buy this training via bank transfer, send us an email at academy@ambit-iberia.com

Invoicing: if you need an invoice in your company's name, enter all the details when purchasing the training, after 'complete purchase,' and the Ambit Iberia admin team will send it by email after the purchase.
Discounts
- 15% OFF when enrolling in more than one course.
- 15% OFF for groups from the same company.
- 15% OFF if you are a member of Catalonia.Health, Barcelona Health Hub or Madrid Health Hub.
Non-cumulative discounts.

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