Data Integrity & Computer Systems Validation (CSV): comprendere le attuali aspettative regolatorie

Struttura del corso

09:30 – 12:30 SESSIONE MATTINA
14:00 – 17:00 SESSIONE POMERIGGIO

Regulatory Requirements and Expectations
– Regulatory Trends in Data Integrity and Validation
– Overview di recenti Warning letters
10.45 – 11.00 Coffee Break

Validation Standards
– GAMP5: Design of a new Computerized System
– IT Infrastructure Layer and Regulatory Expectations
12.30 – 14.00 LUNCH

Validation Practices
– Compliance Assessment Strategy
– How to select System Suppliers for Data Integrity Assurance
– Software Validation (Best Practices)
– Operational Processes
15.30 – 15.45 Coffee Break

Case studies
– Upgrade of a LAS (prospective validation)
– Cyber attack management (Disaster Recovery)
– LIMS Integration and Validation
– Paperless Manufacturing
– ERP/MES/EBR/SCADA Implementation Project
– Development and Validation of Custom Software

Q&A Session

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.

Attendance to the event will be allowed upon receipt of payment.

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.