7 - 8 November 2019 | The Lalit Mumbai



The trainer with 38+ years of experience leading this 2 day workshop

Validation of computer systems has become imperative over the last decades as it plays a vital role in getting compliant with GAMP guidelines. As there are latest tools & technologies available to validate computer systems, pharmaceutical manufacturing companies have to meet regulatory guidelines and expectations to avoid 483s and pass FDA inspections.

This training course has been designed to familiarize trainees with key challenges encountered during computer system validation and how to overcome them so as to avoid regulatory citations. Case studies from trainer's field audits of US companies will be utilized to focus on the challenges of implementing P11 and A11 in a paperless world in the cloud.

This training will start out with a compendium on the fundamental principles of validation and then it will transition into topics that will familiarize trainees on the techniques to assess, manage, and validate computerised system and its related risks. Detailed discussion on implementation of GAMP 5 guidelines, FDA's latest approach on CSV, data integrity concerns and PLC validation will be discussed,

This two-day course will feature the trainer's reputation for interactive discussions, encouraging trainee participation and using specific examples from the field gathered from his regular audits of pharmaceutical companies in the US and Europe.

IT, Quality Assurance, Quality Control, R&D and validation professional from Pharmaceutical, APIs, life sciences and biopharmaceutical industries engaged in the development of systems and software and makes sure system will repeatedly and reliably do what it is designed to do would also benefit from this training.

Key Objectives


How to implement

a cost-effective CSV without increasing compliance risk


How to identify

what to validate


How to ensure

that all items identified as requiring validation are validated


What are the essential

components of a Computer System Validation Protocol


How to assess

systems and software for CFR 21 Part 11 compliance


What QRM

tool is gaining wide acceptance


What is Data

Integrity's Controls triad and 5-p model


What is US FDA's

current thinking on CSV

About the Workshop Trainer

Chinmoy Roy BSEE, MSCS

Specialist: GAMP, CSV, CFR 21 Part 11, QRM, Manufacturing Process Automation

Chinmoy Roy is an internationally recognized subject matter expert in CSV, CFR 21 Part 11, Annex 11, QRM and manufacturing process automation systems. He has been invited to speak and conduct training workshops at several international conferences such as ISPE, WBF etc. His expertise stems from his 38+ years of experience in implementing and obtaining "fit for use" certification for over 200 IT systems. He has worked at and consulted with several leading companies such as Roche, Genentech, Bayer, Novartis, Johnson and Johnson etc. He has authored several QA Governance documents, facilitated numerous Quality Risk Assessments and provided input to ISA's development of standards such as S88 and ISPE's Records and Data Integrity guide. HHIs foundational experience is in Manufacturing automation to include PLCs, DCS and MES. His training workshops are unique in that he blends his field experience to provide practical situations to explain the intricacies of implementing regulations. His trainees have found this approach as something that relates directly to their daily work situation.

Key Features

Well known Trainer who will lead this 2-day workshop

Interactive case studies and Group exercises

12+ hours of extensive learning from the guru of validation

Learn how to implement GAMP 5 guidelines

Overcoming challenges on adopting paperless validation

Learning from past 483s & warning letters on CSV

Key Topics

Understanding & adoption of GAMP 5 guidelines on computer system validation
Understand Strategies of audit trail and learning from warning letters on CSV
Developing a good URS with case studies and examples
Adoption and implementing paperless validation
5 key elements of Data Integrity and setting up Audit trail review SOPs
Knowing what is US FDA's current thinking on CSV
Learning Risk mitigation techniques using design architecture of PLC/DCS/MES Automation system

Who should attend

Industries / Categories

Pharmaceuticals, Life sciences, APIs and Bio-Pharmaceuticals


Vice Presidents, Associate Vice Presidents, CQA Head/ Plant Head, Deputy General Manager, General Manager, Senior Managers, Managers, Assistant Managers and Senior Executives


Quality Assurance, Quality Control, IT, Validation and R&D

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