CPhI Conferences through this workshop will offer professionals from the pharma industry an understanding of regulatory requirements and risk-based approach under GAMP5 guidelines
CPhI Conferences, a division of UBM India, has announced the 4th edition of ‘Computer System Validation’ Workshop, which will be held in Mumbai from November 9-10, 2017. CPhI Conferences through this workshop will offer professionals from the pharmaceutical industry an understanding of regulatory requirements and risk based approach under GAMP5 guidelines, how to deal with data integrity related issues with the support of good documentation practices, knowledge of overall challenges that occur during validation and strategies to overcome those challenges.
This year, the workshop will feature Sam Brooks, an internationally recognised expert in the area of computer system validation for pharmaceuticals and process equipments. His role has developed through real-time software development, engineering maintenance and governance of IT teams. Sam Brooks has worked with both large and small pharmaceuticals companies on various aspects of computer system validation. He has led and delivered integrated strategies for achieving IT compliance with corporate computer systems validation and information security at Novartis as OTC global head IT compliance.
Key topics of the workshop include, ‘regulatory requirements and recommendations under 21CFR part 11’, ‘strategies for good documentation practices’, ‘recent 483s issued on CSV and data integrity’, ‘validating PLC machines’, ‘cloud and mobile application validation’, and ‘risk assessment for software and systems’ amongst others.