Seven Habits of Highly Compliant Pharma Company – Nine days Mastering CSV- GAMP5- CFR part11 and Data Integrity Training Most Pharma 483 and warning letter can be avoided if the Company QA work with Proactive Compliance, Validation as well as periodic review and Internal Audit. Begin with End in mind Like patient Safety, product Quality and Data Integrity. Think Win- Win For patient, Government, Staff and vendors. Sharpen the saw means Training - Retraining First in First out means being real time with Contemporaneous plus many thing. In our two days seminar we try to generate the confidence, faith, belief and conviction in Compliance, along with different guideline like GAMP5, 21 CFR Part11 Compliance, Annex11, Risk Assessment, Data Integrity and make you master in Compliance. Ofcourse you need to remain active and learn all changes later on. You can join our training as a repeat standard member at attractive price Good Compliance has all Quality of “GOD” Generate Operate and Destroy (Data Life Cycle, SDLC Life Talks aboy the same thing) #training #reviews #howto #vendors #patientsafety #riskassessment #dataintegrity #productquality #confidant #gamp #21cfr #internationalauditing

1. OVERVIEW KEY TOPICS
This training course on
Computer System Validation
covers on how to use a risk-
based approach in Computer
System Validation (CSV). The
course provides compliance
with GMP 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
• Group Discussion
• GAMP5 GUIDELINES – RISK BASED APPROACH
• 21 CFR PART 11 & ANNES 11 FOR CSV
• RISK BASED APPROACH & RISK MANAGEMENT VALIDATION
• SYSTEM LIFECYCLE
• CHANGE MANAGEMENT
• DATA INTEGRITY
• DATA SECURITY
• 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
• Be able to use GAMP5 Risk based approach
• Understand the major life phase of computerized systems
• Understand software categorization and the Validation
efforts required for various computerized systems
• Understand computerized system validation from a
regulator’s perspective
• Understand CFR Part 11 compliance and Annex 11 for CSV
• Understand Good Documentation Practices
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INFRAICS@GMAIL.COM
HTTPS://WWW.YOUTUB
E.COM/C/KALPESHVAG
HELACSVTRAINERANDC
ONSULTANT
+919825047998
+918320551508
HTTPS://WWW.LINKEDIN.
COM/IN/CSVREMDIATION
TRAININGPARTNER
COMPUTER SYSTEM VALIDATION TRAINING
BY KAPESHKUMAR VAGHELA

2. SPEAKER:
KALPESHKUMAR
VAGHELA
We’ve included a few tips throughout the
template to help you get started.
ADDRESS
A9 Triloknagar Society, Gotri-Vasna Link Road, Vadodara
390021, Gujarat, India.
CONTACT US
Infra Control Systems | +91 9825047998; +918320551508 |
www.infraics.in
WEBINAR ON
COMPUTER
SYSTEM
VALIDATION
Add a brief description of the event se e
here

3. 1. BASIC OF VALIDATION AND
QSIT COMBINED
• Why the need for Validation came in
to picture?
• Benefits of Validation
• Validation Definition
• Formation of Validation Team and
their responsibility
• Brief Details of Predicate Rules
CFR211/210
• QSIT
• Marketing is all P and Compliance is
also all P
• Change Control, CAPA, Incidence
and Some SOP
2. GAMP 5 ON BOTTOM PART
• GAMP5 Driver
• Patient Safety- product Quality-
Data Integrity
• CQA-CPP
• QbD Systems
• SDLC Life Cycle
• Vendor Qualification, SLA
• Why SME
• Software and Hardware category
• Network QUALIFICATION
• Difference between Qualification
and Validation
• Why to Calibrate?
• Data Life Cycle and GxP work flow
Needs to be focused.
• Types of Validation Prospective,
Concurrent and Retrospective.
3. 21 CFR PART 11 COMPLIANCE
IN DETAILS, DATA INTEGRITY
AND SECURITY. BASIC AND
ADVANCE TWO SESSION
• Main points
• Legacy System
• Open System
• Close System
• Electronic Records
• Hybrid Systems
• CONTACT US
• Electronic Signature
• Digital Signatures
• Biometric
• Black box
• White box
• Patch Management
• Periodic Review
• Audit Trail and Audit Trail review
• Data backup – Restoration, Archival- Retrieval and data
Retention.
• Annex 11
4. DATA INTEGIRTY AND COMMON ISSUES
• Data Integrity, Data Life Cycle, Data Governance
• Raw, meta data, Static, Dynamic Data, Structured, Unstructured
Data, Active, Passive data
• Data Integrity Part, Cloud Validation
• ALCOA+ + Is about Data Life Cycle
5. RISK ASSESSMENT
• Basic Understanding
• Various types of Risk Assessment method
• Risk Assessment Sod, RPN no.
• Selecting and qualifying the right vendor – Risk Based Approach as
per GAMP category
• Example
• Benefit of risk assessment in large project
• Data Integrity How to control?
6. CLOUD VALIDATION
• What is cloud?
• Types of Cloud
• IaaS, PaaS, SaaS
• RTO-RPO
• Cloud Vendor Selection
• SLA
• Cloud Validation Points
• Benefit of Cloud.
• Risk Associated with cloud
7. VALIDATION DELIVERABLES
“LEADERS
NEVER
STOP
LEARNING”

4. Contact US
7. VALIDATION DELIVERABLES
• This Session will be in Multiple Part.
• Computer Validation as per GAMP5
• CSV Deliverable
• SDLC Life Cycle Phase How to address
• User Requirement Specifications, Why to Write meaningful specifications/requirements (URS)
• Initial Risk Assessment- Gxp Assessment
• Validation Plan
• Vendor Assessment
• Supplier Agreement – SLA
• FS-DS or SRS
• Risk Assessment, using risk-based approach for CSV
• Installation Qualification – Protocol and report
• Operational Qualification Protocol and Report
• Important SOPS
• Traceability requirement matrix
• Summary Report
• System release Certificate
• Maintenance Qualification- Periodic review,
Change Control, Incidence Management and Revalidation - Addendum
• System retirement
• How validation helps to improve your business
8. CASE STUDIES
• This will be a group activity.
• What to do after Good Validation to maintain system in a Validated state.
+919825047998
+918320551508
infraics@gmail.com
+919825047998
+918320551508
Kalpeshkumar Vaghela
Kalpeshkumar
Vaghela
Kvstechnologieskrv

5. KEY TOPICS 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)
(ComputerizedSystem)
3. GOVERNANCE AND
VALIDATION
A. Validation Strategy
B. Validation Framework
C. Validate and Quality PLC
Machines
D. GoodDocumentation
Practices & Management
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
INFRAICS@YAHOO.COM
INFRAICS@GMAIL.COM
TWITTER HANDLE +919825047998
+918320551508
HTTPS://WWW.LINKEDIN.
COM/IN/CSVREMDIATION
TRAININGPARTNER
COMPUTER SYSTEM VALIDATION TRAINING
BY KAPESHKUMAR VAGHELA

6. 16. SE
A. Dat
B. Dat
C. Dat
D. AL
E. Re
F. Clo
17. RE
18. INS
19. CO
20. CA
CURITY
a Security
a Integrity in CSV
a Migration
COA+
cent 483s issued on CSV and Data Integrity
ud Validation
MEDIATION
PECTION READINESS
NCLUSION AND Q&A
SE STUDY AND WORK EXERCISE
INFRAICS@YAHOO.COM
INFRAICS@GMAIL.COM
HTTPS://WWW.YOUTUB
E.COM/C/KALPESHVAG
HELACSVTRAINERANDC
ONSULTANT
+919825047998
+918320551508
HTTPS://WWW.LINKEDIN.
COM/IN/CSVREMDIATION
TRAININGPARTNER
COMPUTER SYSTEM VALIDATION TRAINING
BY KAPESHKUMAR VAGHELA

7. TOPICS
1. GAMP5 FOR COMPUTERISED SYSTEMS
10-11 Aug 2020 @6:00 AM IST
2. 21 CFR PART 11 & ANNES 11 FOR CSV
12-13 Aug 2020 @6:00 AM IST
3. RISK ASSESSMENT & RISK MANAGEMENT
14 Aug 2020 @6:00 AM IST
4. DATA INTEGRITY
15 Aug 2020 @6:00 AM IST
5. CLOUD VALIDATION COMPLIANCE
16 Aug 2020 @6:00 AM IST
INFRAICS@YAHOO.COM
INFRAICS@GMAIL.COM
HTTPS://WWW.YOUTUB
E.COM/C/KALPESHVAG
HELACSVTRAINERANDC
ONSULTANT
+919825047998
+918320551508
HTTPS://WWW.LINKEDIN.
COM/IN/CSVREMDIATION
TRAININGPARTNER
COMPUTER SYSTEM VALIDATION WEBINAR
BY KAPESHKUMAR VAGHELA