Validate Smarter: CSV & CSA for Biopharma
Overview
Validate Smarter: CSV & CSA for Biopharma is a two-day, open enrolment course for biopharma professionals who want to get more involved in CSV activities.
Through lectures, group workshops, and a hands-on document review clinic, participants build the practical judgement and tool awareness (including digital validation platforms and AI-assisted activities) needed to engage confidently in CSV and CSA activities within their own organisation.
Key topics covered
· The CSV lifecycle (URS, FS/DS, risk assessment, IQ/OQ/PQ, traceability, periodic review)
· GAMP 5 software categorisation
· Computer Software Assurance (CSA) and risk-based testing
· Data integrity & audit trails (ALCOA+)
· Digital validation platforms & AI-assisted validation activities
Who should attend
Biopharma professionals looking to get more involved in CSV activities, particularly those in QA and business process owner roles.
Typical attendee roles:
· QA Managers and Quality Specialists
· Business Process Owners · Validation Engineers
· Regulatory Affairs professionals
· Operations and Manufacturing Leaders with system ownership responsibilities
What do Attendees Obtain on Completion?
Attendees will receive comprehensive course materials and a certificate of completion.
Register
Course Format
Onsite Training at NIBRT
Onsite Training at NIBRT
- 2 full days onsite training at NIBRT facility
Dates & Price
Dates:
- Course 1 05/11/2026 - 06/11/2026
Training Onsite at NIBRT
€1,995.0012 Places Remaining
