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Computer system validation workshop
November 9, 2017 - November 10, 2017
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:
- To understand regulatory requirements and risk based approach under GAMP5 guidelines.
- To deal with data integrity related issues with the support of good documentation practices.
- To know overall challenges that occurs during validation and strategies to overcome those challenges.