Infra Control Systems (ICS) is running a Mastering the CSV Course for a small team of 10 people for US, Europe and Far East team since last two years.
Now since webinar has started in a big way we decided to give the training to more no of people and hence the message in the social media for this kind of nearly One to one Type Training in a small group.
Generally Industry experts join this training with some Beginner or experienced people wanting to know and study CSV and Data Integrity points to sharpen the Saw.
Software Development Life Cycle goes hand in hand with Skill Development Life Cycle
https://youtu.be/dJ1Cxo6YgME
We try to cover Basic to advance things in this Eight day Course.
Course will start from Monday 20th July 2020 at 6:00 hrs (IST GMT+5.30 hrs) in the morning and will run daily till it gets completed.
Small adjustment in timing possible as per participants and also Weekly off can be planned as per the need.
Please call On +919825047998, +918320551508
It is a Whatsapp plus IMO no.
You can also write to infraics@gmail.com or connect to us through linked in.
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Mastering Compliance
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