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INFRAICS@YAHOO.COM
INFRAICS@GMAIL.COM
TWITTER HANDLE +919825047998
+918320551508
HTTPS://WWW.LINKEDIN
.COM/IN/CSVREMDIATIO
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
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

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  • 1. INFRAICS@YAHOO.COM INFRAICS@GMAIL.COM TWITTER HANDLE +919825047998 +918320551508 HTTPS://WWW.LINKEDIN .COM/IN/CSVREMDIATIO 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