The document outlines a training program on Computer System Validation (CSV) led by Kapeshkumar Vaghela, focusing on key topics such as regulatory guidelines, validation strategies, risk management, and data integrity. It encompasses various aspects including GxP assessments, document management, incident handling, and security measures. The training aims to provide a comprehensive understanding of CSV practices and compliance requirements.

1. INFRAICS@YAHOO.COM
INFRAICS@GMAIL.COM
TWITTER HANDLE +919825047998
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NTRAININGPARTNER
KEY TOPICS
1. INTRODUCTION
A. What is computerized
system?
B. What is CSV and its history?
C. Why CSV and the big
picture?
I. GMP
II. GCP
III.GLP
2. DATA INTEGRITY
REGULATIONS &
GUIDELINES
A. MHRA
B. FDA AND ITS ROLE
C. ICH
D. PIC/S
E. GAMP (ISPE)
(Computerized System)
3. GOVERNANCE AND
VALIDATION
A. Validation Strategy
B. Validation Framework
C. Validate and Quality PLC
Machines
D. Good Documentation
Practices & Management
COMPUTER SYSTEM VALIDATION TRAINING
BY KAPESHKUMAR VAGHELA
KEY TOPICS
4. GAMP 5 GUIDELINES
A. Introduction to GAMP5 Guidelines & risk-based approach
B. GAMP4 vs GAMP5
C. GAMP5 Drivers and Deliverables for CSV
D. Computer Validation as per GAMP5
E. GXP Assessment
5. SYSTEM LIFECYCLE
A. Software & Hardware Categories
6. CHANGE MANAGEMENT
A. Overview of Objectives and types of changes
7. PATCH MANAGEMENT
8. INCIDENT MANAGEMENT & PROCESS
9. REGULATORY REQUIREMENT UNDER 21 CFR PART 11 AND ANNEX
11 FOR CSV
A. Main points
B. Types of Systems
C. Records & Signatures
10. RISK MANAGEMENT
A. Risk Assessment using Risk Based Approach for CSV
B.Risk & Causes
11. USER REQUIREMENT SEPCIFICATION (URS), FUNCTIONAL
SPECIFICATION (FS), CONFIGURATION SPECIFICATION (CS)
12. DATA MIGRATION
13. OPERATION ASPECTS
A. Backup and Restore
B. Disaster Control & Business Continuity Planning & Testing
C. Periodic Review
D. Data Archive & Retrieval
14. TRACEABILITY
15. DOCUMENT MANAGEMENT

2. COMPUTER SYSTEM VALIDATION TRAINING
BY KAPESHKUMAR VAGHELA
INFRAICS@YAHOO.COM
INFRAICS@GMAIL.COM
HTTPS://WWW.YOUTUB
E.COM/C/KALPESHVAG
HELACSVTRAINERANDC
ONSULTANT
+919825047998
+918320551508
HTTPS://WWW.LINKEDIN
.COM/IN/CSVREMDIATIO
NTRAININGPARTNER
16. SECURITY
A. Data Security
B. Data Integrity in CSV
C. Data Migration
D. ALCOA+
E. Recent 483s issued on CSV and Data Integrity
F. Cloud Validation
17. REMEDIATION
18. INSPECTION READINESS
19. CONCLUSION AND Q&A
20. CASE STUDY BASED ON WORK EXERCISE