The 4th edition of ‘Computer System Validation’ is scheduled on 9th – 10th November 2017 at Meluha The Fern An Ecotel Hotel Mumbai will be led by Mr. Sam Brooks, Principal Consultant at Brooks Information Integrity Innovations. This workshop will help you to make your system ‘fit for purpose’ by adopting risk based approach under GAMP5 guidelines.
KEY TOPICS OF THE WORKSHOP
Regulatory requirements and recommendations under the 21CFR Part 11, and EMEA Annexure 11 for Computer Systems Validation
Strategies for Good Documentation practices
Risk Assessment for software and systems
Cloud and Mobile Application Validation
How to validate and qualify PLC machines
Achieving compliance by building a complete understanding of GAMP5
Recent 483s issued on CSV & data integrity
Special session by Indian Pharma Expert on ‘Enterprise Application Validation’
Validation of computer systems has evolved over the last decade and now it is considered as an integral part of GxP requirements. While the methodology has developed and advanced with latest version of GAMP guidelines, the complexity of software technology still leaves a gap between the regulatory expectations and the awareness of the guidelines. This can result into increased scrutiny by FDA which may lead to warning letters received by pharmaceutical companies.
To ensure that companies successfully pass FDA inspections and to also make sure that system and its applications fulfil its intended purpose, CPhI Conferences is pleased to announce the 4th Edition of ‘Computer System Validation Workshop’ which is scheduled on 9th -10th November, 2017 in Mumbai.
The workshop will help you:
1) To understand regulatory requirements and risk based approach under GAMP guidelines.
2) To deal with data integrity related issues with the support of good documentation practices.
3) To know overall challenges that occurs during validation and strategies to overcome those challenges.
Date : 9th – 10th November 2017
Venue : at Meluha The Fern An Ecotel Hotel Mumbai
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