The document provides an overview of a training course on computer system validation (CSV) led by Kapesh Kumar Vaghela, focusing on a risk-based approach aligned with CGMP requirements. Key topics include GAMP5 guidelines, compliance with CFR Part 11, and data integrity, with various interactive components such as quizzes and group discussions. Participants will gain comprehensive knowledge applicable to their work in CSV and understand regulatory perspectives on validation.

1. INFRAICS@YAHOO.COM
INFRAICS@GMAIL.COM
HTTPS://WWW.YOUTUB
E.COM/C/KALPESHVAG
HELACSVTRAINERANDC
ONSULTANT
+919825047998
+918320551508
HTTPS://WWW.LINKEDIN
.COM/IN/CSVREMDIATIO
NTRAININGPARTNER
OVERVIEW
This training course on
Computer System Validation
covers risk-based approach
in Computer System
Validation (CSV). The course
provides compliance with
cGMP requirements and
specifically designed for
professionals. By using a risk-
based approach and in-depth
understanding of various CSV
methodologies’ including
GAMP5 guidelines,
Validations, Annex 11 and the
CFR Part 11.
COURSE DELIVERY
• Live training
• Interactive Session
• Q&A in each session
• Examples
• Case Studies - Quiz
• Group Discussion
COMPUTER SYSTEM VALIDATION TRAINING
BY KAPESHKUMAR VAGHELA
KEY TOPICS
• GAMP5 GUIDELINES – RISK BASED APPROACH
• 21 CFR PART 11 & ANNES 11 FOR CSV
• RISK BASED APPROACH & RISK MANAGEMENT VALIDATION
• SYSTEM DEVELOPMENT LIFECYCLE
• CHANGE MANAGEMENT
• DATA INTEGRITY
• QSIT AND CSV DELIVERABLES
• CLOUD VALIDATION ALCOA+
• REMEDIATION
• WARNING LETTERS, 483S, ETC
WHAT YOU WILL LEARN
After completing this course, participants will:
• Have a thorough understanding of the Validation & it’s
application to computer systems intended use.
• Be able to use GAMP5 Risk based approach
• Understand the major life cycle of computerized systems
• Understand software categorization and the Validation
efforts required for various computerized systems
• Understand computerized system validation from a
regulator’s perspective. Data integrity issues under control
• Understand CFR Part 11 compliance and Annex 11 for CSV
• Understand Good Documentation Practices

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
Saudi Arabia Program for SFDA & Industry
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3. 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
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4. 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
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5. 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
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