Follwing Topics will be covered as Minimum as part of CSV Course:-
Module 1: Software Validation & Infrastructure Qualification
Module 2: Computer System Validation (CSV) - Overview, Regulatory requirements (GAMP & 21 CFR Part 11) and documentation
Module 3: High Level Risk Assessment (GxP Assessment, Software Categorization as per GAMP 5, ERES Assessment)
Module 4: GAMP 5 and documentation (URS, FS, DS, CS, Source Code Review Report, Validation Plan, Validation Report, Test Plan & Test Summary Report)
Module 5: Testing of Computerized System (IQ, OQ, PQ, UAT, Regression Testing, Smoke Testing, Sanity Testing)
Module 6: Penetration Testing (Threat Modeling, SAST & DAST)
Module 7: Excel Sheet Validation
Module 8: Cloud Computing (SaaS, PaaS, IaaS)
Module 9: Software Development Life Cycle (SDLC) : Waterfall, V-Model, Agile Methodology, DevOps etc.
Module 10: Back-up and Restore, Archival & Retrieval of Data
Module 11: Business Continuity Management
Module 12: System Retirement & Data Migration
Module 13: Quality Management System and Quality Risk Management
Module 14: Computer Software Assurance (CSA Approach), A New way of working for CSV
Following Live Projects will be teach to candidates
Data Acquisition System (DAS)
Chromatographic Data System (CDS)
Packing US-Serialization System
Eligibility
Graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.
Upon Successful completion of Course our team will provide Following
Resume Preparation
Interview Preparation and Mock Interview Session.
Communication skills and personality development sessions
Placement Assistance
Computerized System Validation Course
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