The learner has successfully completed a 3-month Professional Certification Program in CSV, CSA (Risk-Based Validation), and AI/ML in Pharma, conducted by i Connect Consultants.

This program provided comprehensive theoretical and practical exposure to pharmaceutical compliance and IT fundamentals, including:

Computerized System Validation (CSV) and Computer Software Assurance (CSA)

Risk-based validation principles and GAMP 5 (Second Edition) categorization

Regulatory requirements such as 21 CFR Part 11 and data integrity expectations

Validation lifecycle and documentation (URS, FRA, IQ, OQ, PQ, RTM)

Basics of Information Technology, including SDLC, Agile and Scrum methodologies

Practical understanding of IT quality and validation tools such as Jira and HP-ALM

Fundamentals and use cases of AI & ML in pharmaceutical systems

The learner successfully completed all required training sessions, assessments, and a practical project, demonstrating readiness to work in pharma IT, validation, and compliance-driven environments.