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ABHAY JADHAV Courses
Pharma Computer System Validation (CSV & Quality)
4.4 (1,487 Reviews)
Provider: Udemy
Time: 6.8h- 2024
$64.99
Visit
Most Recent Review
Pace of the person is Good, It would really help if he touches upon CSV and what it is in detailed before jumping into the details of the course material/contents. Very boring way of delivery.
- Review by Ravi Peri on Pharma Computer System Validation (CSV & Quality)
Instructor Bio
· Diversified experience across Application Development & Application Maintenance predominantly in End to End Computer System Validation (CSV), Quality Assurance and Control, Regulatory Compliance, Regulatory Submissions, Regulatory Consulting, Process Consulting, Data Migration and verification.
· Expertise in Quality Systems Auditing (GxP Inspection readiness, SOx and Internal Control Audits) for Life Sciences Industry
· Expert in designing validation strategies and procedures for large SAP ERP deployments and maintenance activities
· Proficient in ensuring Quality Assurance for computerized systems across pharmaceutical development lifecycle (Clinical, Supply Chain, PV etc.) for big pharma companies
· Strong domain knowledge in Procure to Pay (P2P),Order To Cash (OTC) and Manufacture to Demand (M2D) business processes in SAP ERP
· In-depth understanding of industry accepted software development and validation life cycle programs and related IT controls
· Certified Scrum Master (CSM) in Agile Methodology
