[go: up one dir, main page]
Scribd
Upload
900 views1 page

CSV Training Course Details

This document outlines a 25 topic, 25 hour CSV training course on computerized systems validation. The course covers topics like GAMP5 guidance, 21 CFR Part 11, EU Annex 11, data integrity, risk assessment, validation plans, testing, and change control. The course fee is 20,000 Rs including GST and certification. Participants must have a B.E/B.Tech/MSc./M.Pharma/B.Pharm degree to enroll by contacting the phone number or email listed.

Uploaded by

Abdul Kalim
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
900 views1 page

CSV Training Course Details

This document outlines a 25 topic, 25 hour CSV training course on computerized systems validation. The course covers topics like GAMP5 guidance, 21 CFR Part 11, EU Annex 11, data integrity, risk assessment, validation plans, testing, and change control. The course fee is 20,000 Rs including GST and certification. Participants must have a B.E/B.Tech/MSc./M.Pharma/B.Pharm degree to enroll by contacting the phone number or email listed.

Uploaded by

Abdul Kalim
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 1

Contact:

CSV Training Course +91-9390056495


csv@valsquare.in

S.No. Training Topics Hours

1 Introduction to Computerized Systems One Hour

2 Overview on GAMP5 Guidance One Hour


3 Introduction to 21 CFR Part 11 One Hour
4 Introduction to EU Annex 11 One Hour
5 Data Integrity One Hour
6 Initial Risk Assessment (GxP) One Hour
7 User Requirement Specification One Hour
8 Validation Plan One Hour
9 Supplier Assessment and ERES Assessment One Hour
10 Functional Specification One Hour
11 Design and Configuration Specification One Hour
12 Quantitative Risk Assessment One Hour
13 Factory Acceptance Test (FAT) & Site Acceptance Test (SAT) One Hour
14 Installation Qualification (IQ) One Hour
15 Operational Qualification (OQ) One Hour
16 Performance Qualification (PQ) One Hour
17 Regulatory Compliance Assessment One Hour
18 Traceability Matrix One Hour
19 Validation Summary Report One Hour
20 Change Control Management One Hour
21 Periodic Review One Hour
22 System Retirement One Hour
23 Data Management and Disaster Recovery Management procedure One Hour

24 Q&A and Certification One Hour

25 Practical Training One Hour

Course Fee: 20,000/- Rs (Including GST) – [With Certification]

Educational Qualification: B.E/B.Tech/MSc./M.Phama/B.Pharm

Contact us to Enroll @ +91-9390056495, csv@valsquare.in

You might also like