Computerized Systems Validation- Current Perspective and

Practical Approach


Why Computerized Systems Validation
Training?

Computerised System Compliance has evolved in
last decade to become an integral part of GxP
requirements. While the methodology has developed
and matured with latest version of GAMP
guidelines, the complexity of software technology
still leaves a gap between the Regulatory
Expectations and the awareness and knowledge at
working level executives.
This training has been designed to bridge this gap.
Presented by industry expert with vast experience of
Technology and Compliance, this training covers a
Practical Approach to Computerised System
Validation and Electronic Records Management
(e.g. US FDA 21 CFR Part 11 Compliance.)
Course Topics

Module1: Computer System Validation Overview and Approach
Topics covered:
Need of Computerized System Validation
FDA/EU expectations, Electronic Records Definitions, US FDA Part11 expectation,
EU Annexure 11 expectations.

Module2: Validation Approach & Good Practices-GAMP 5 approach
Topics covered:
GAMP 5 Evolution and concepts
CSV Documentation and Risk Management
Validation of existing systems
Spreadsheet compliance
Infrastructure Qualification

Module 3: Lifecycle Management Issues
Topics covered:
Operation control of Computerised Systems
Periodic Review

With the help of this workshop, participants will be able to apply the knowledge gained during
training modules to create various sample documents based on case studies provided. The
participants shall be divided into various groups and shall prepare a strategy for effective compliance
to the computerised system. Following typical documentation shall be covered under the same.
How to write URS
Creating Validation Plan
Carryout Risk Assessment
GxP Testing examples
Date: 5
th
& 6
th
September, 2014
Venue: IRIS Hotel, Bangalore








Trainers Profile

Mr Vasishtha Mehta

Mr Vasishtha Mehta has Industrial experience of more than 25 years. His specialization is in the
area of Process Study and Application Mapping to design Optimum Automation Solution. His
current focus area is Regulatory Compliance Requirements as well as Emerging Trends in
Automated Systems including Process Analytical Technology and Integrated Quality Systems
for the Life Science Industry.
Mr Mehta has been involved in successful completion of various Computerized System
Validation and US FDA 21 CFR part 11 Compliance Projects including Process Control
systems (PLC/DCS/SCADA/BMS), Laboratory Computerized Systems (LIMS/HPLC/etc), ERP
Systems (SAP/BaaN/JDE/Oracle) & Clinical Trial Applications like SAS/WinNolin. He has
carried out number of Seminars on
a) Computerized System Validation
b) US FDA 21 CFR part 11 Compliance
c) Risk Based Approach for Computerized System Validation
d) Data Management in GxP Environment
e) GAMP Good Practices for PCS, LCS & GIS
with some of the Top Indian Pharma companies and also with overseas. He has also been
invited to present seminars by ISPE India Chapter, Indian Pharmaceutical Association and
various other private bodies.

Registration Fees: Rs 6,000/-* for any one day
Rs 11,000/-* for both the days
10% discount for group of 3 or more





Registration Process / Query / Payment Details
Send a mail to admin@scientiabio.com with subject line Computerized Systems Validation Workshop
Call us at +91 99453 18216 or +91 77608 79299
Visit our website www.scientiabio.com to find out more details.



Who should attend?
Quality Assurance personnel
Quality Control personnel
Operations or Manufacturing personnel
IT personnel
Course Format
The two days programs are a combination of lecture-style learning and active workshops with
participants working in small groups on assigned tasks.