Guide to IT infrastructure qualification in GMP environments

  • 2° EDITION: 29 May 2024
  • Online
  • Italian

Training overview

The training course “Guide to IT infrastructure qualification in GMP environments” aims to delve into the importance of IT infrastructure and the requirements under applicable regulations. In regulated environments such as pharmaceutical and biomedical, the IT infrastructure is the foundation on which applications used to execute various business processes reside. The validation activities required for software in compliance with EU cGMP – Annex 11 are directly interconnected with the qualification of the corporate infrastructure network, so the definition of requirements for IT security has become increasingly important: only a robust IT infrastructure can ensure appropriate security.

Would you like to participate, but you’re not available on this date?
The course will be provided again:

  • October 17th 2024
  • February 24th 2025

(*) Contact us via email or phone to enroll.

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(*) discounts apply to the full prices of the courses and cannot be combined with other promotions. The promotion is limited to enrolling the same person in 3 courses selected from those offered.

Key points of the training

  • Overview of IT requirements under applicable regulations
  • Insight into the importance of IT infrastructure aspects
  • Documentary aspects related to IT infrastructure qualification
  • Case studies of IT infrastructure qualification

09:00 – 13:00 COURSE SESSION

  • Regulatory Expectations
  • IT infrastructure and Data Integrity
  • IT infrastructure compliance assessment
  • IT infrastructure qualification
  • Maintenance of IT network
  • Provider IT management

IT, QA, Validation Responsible.

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.


Mirko Mori

Mirko Mori

Project Manager Data Integrity and Systems Compliance & CSV Head at C&P Engineering

Mirko Mori graduated in chemistry at the University of Florence and doctorate in chemistry at the C.E.R.M. institute, Florence. He spent three years in the academic world as a researcher, applying NMR techniques to the study of biomolecules. Since 2010 he has been working as a Project Manager in a consulting firm with experience in Validation of IT systems and compliance with 21 CFR Part 11 and EU cGMP Annex 11. In over 10 years of experience, he has managed the validation of computerized systems used in pharmaceutical and related environments (e.g. ERP, MES, LIMS, LAS, PCS) and supported the implementation of quality systems for IT governance. He gained experience in GxP data management, focusing on data governance lifecycle in regulated environments. In this area, he has managed over 300 validation projects worldwide for major pharmaceutical companies. Currently, he works at C&P Engineering s.r.l. as head of the Data Integrity & Systems Compliance unit.

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Early Bird 10%
Within 2 months before the start of the training
Early Bird 5%
Within 1 month before the start of the training
Full price


Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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