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ONLINE COURSE

Infrastructure for the maintenance and management of GxP systems

Get a complete overview of infrastructures in GxP environments!

Understand how the different components of the technology infrastructure contribute to ensuring the availability, security, integrity, traceability and operational continuity of GxP systems throughout their lifecycle.

What will you learn?

✔ Understand the fundamental principles of infrastructure management in regulated environments and their connection with ALCOA+ data integrity principles.

✔ Identify the different storage methods and models, from on-premises infrastructures to cloud and SaaS solutions.

✔ Learn about backup, recovery, and data and system restoration processes.

✔ Understand how a Disaster Recovery plan is structured and managed in a GxP environment.

✔ Differentiate between backup and archiving, as well as understand their goals and regulatory requirements.

✔ Identify the main types of monitoring and their role in maintaining validated status.

✔ Understand the function of ticketing systems in managing incidents, requests, problems, and changes.

✔ Understand the key components of GxP system security and their integration into the validation lifecycle.

✔ Identify the necessary documentation to manage and maintain systems and infrastructures in regulated environments.

✔ Link infrastructure, security, monitoring, and support activities with the main applicable regulatory and compliance requirements.

ONLINE

4 hours

300€

per person

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Content
Target audience
Details
Discounts

Content
- Module 1: Back up & Restore
- Module 2: Disaster Recovery
- Module 3: Archiving
- Module 4: Monitoring
- Module 5: Ticketing
- Module 6: Security
- Module 7: Document Systems
Target audience

This course is aimed at professionals involved in the management, maintenance, support, validation, or supervision of IT systems and technological infrastructures in GxP environments, especially:

- Professionals from IT, infrastructure, systems, and operations departments.
- Quality and Quality Assurance managers and technicians.
- Consultants and specialists in computerized system validation.
- Information security and business continuity managers.
- System administrators, support technicians, and application managers.
- Professionals involved in managing cloud service providers, SaaS, or infrastructure.
- Staff participating in audits, periodic reviews, or maintaining the validated state.
- Professionals from the pharmaceutical, biotechnological, healthcare, medical device, and other regulated sectors who want to expand their knowledge of GxP infrastructures.
Details

Timetable: flexible, you set the pace.

Accessibility: recorded course. 24/7 access to learn at your own pace.

Customized: Tailored training adapted to your or your company’s needs.

Language: Spanish.

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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