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ONLINE COURSE

Specialization Program in Digital Transformation

Gain technical and regulatory knowledge to make your company's digital transformation easier.

What will you learn?

Understand how to manage and maintain technological infrastructures and systems in regulated GxP environments.
Apply the principles of data integrity, security, and regulatory compliance in the management of systems and infrastructures.
Know the best practices for managing on-premises and Cloud infrastructures, including backup, recovery, archiving, Disaster Recovery, and monitoring.
Understand how to handle incidents, problems, requests, and changes while keeping systems in a validated state.
Evaluate and manage Cloud service providers and apply Cloud Computing safely and in compliance with GxP requirements.
Know the main regulatory frameworks and standards applicable to infrastructures, Cloud, and security.
Identify the specific risks associated with using Artificial Intelligence in GxP environments.
Manage the lifecycle of data and AI models, from development and validation to deployment and monitoring.
Apply a validation, risk management, and change control approach adapted to AI-based systems.

ONLINE

12 hours

700€

per person

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Content
Target audience
Details

Content
STAGE 1: Use of Cloud Computing in the GxP-Regulated Environment
- Module 1: Definition and Types of Cloud Computing
- Module 2: Cloud Computing in a GxP Environment
- Module 3: Requirements for CSPs (Cloud Service Providers)
- Module 4: GxP Validation Lifecycle and Data Integrity
- Module 5: Best Practices for Managing Cloud Infrastructures
- Module 6: Cloud Computing Case Study in a GxP Environment
- Module 7: Regulatory Entities and the Cloud (FDA, NIST, ISO 27001)
STAGE 2: Infrastructure for the maintenance and management of systems in GxP
- Module 1: Back up and Restore
- Module 2: Disaster Recovery
- Module 3: Archiving
- Module 4: Monitoring
- Module 5: Ticketing
- Module 6: Security
- Module 7: Document Management Systems
STAGE 3: Introduction to AI in Regulated Environments
- 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 industry
- 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
Schedule: flexible, you set the pace.

Accessibility: available 24/7 for 90 calendar days from purchase.

Included materials:
- Module assessment test
- Training presentation in PDF
- Diploma / Certificate of attendance (downloadable from the same platform)
Payment by Transfer: if you prefer to purchase this training via bank transfer, email us 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 administration team will send it by email after the purchase.

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