Guide to IT infrastructure qualification in GMP environments
- 1° EDITION: 17 October 2024
- 2° EDITION: 24 February 2025
- Online
-
Italian
- 1° EDITION: 17 October 2024
- 2° EDITION: 24 February 2025
- Online
-
-
Italiano
-
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.
Interested in Pharma Engineering & Validation?
Enroll in 3 courses and you’ll get a 15% discount*!
Choose among these titles:
- Training Data Integrity in the Digital Transformation Stage – English Language
- Gli Smoke Studies negli Ambienti a Contaminazione Controllata
- Data Integrity Compliance & Computer Systems Validation
- Guidelines in Ingegneria
- Qualifica dell’infrastruttura IT in ambienti GMP
(*) 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
Program
- 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 info@pharmaeducationcenter.it 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 info@pharmaeducationcenter.it. 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.
Speakers
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.
Register now
580€
Training materials available for attendees
Certificate of attendance
Senior trainers with hands-on experience
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