CSV & IT Systems Validation Conference has been designed to give hands on experience for executing computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, cloud validation and much more. The event is interactive and encourages the active participation of all attendees. Methodologies used in this conference includes workshops, keynotes and discussion sessions.
The conference will have breakout sessions for delegates to choose their preferred track, consisting of workshops and keynotes divided for Technical (production & quality) & IT professionals.
This is an excellent opportunity to connect with IT, CSV and validation experts within the life sciences industry. Shape and magnify your understanding of the regulatory requirements and expectations for the compliance of computerized systems used in pharmaceutical manufacturing.
Key Areas Covered : CSV Trends & Regulatory Insight 21 CFR Part 11 Gap Assessment Data Integrity Masterclass Paperless Validation Adopting ‘Paperless Labs’ Documents, SOPs, Change Control and Audit Trails FDA Audits and Inspections SDLC Methodology Computer Systems Controls Vendor Selection Process Cloud Computing and Cloud Validation GAMP® Methodology Developing an IT Infrastructure Risk Management in Validation Cyber Security
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