4th GxP Cloud Compliance Summit Wyndham Boston Beacon Hill, Boston

Welcome to the 4th GxP Cloud Compliance Summit

The release of the FDA’s new CSA guidance offers life science companies the opportunity to fully capitalize on the advantages of cloud computing – from enhanced resource pooling to expense reduction and rapid scalability. But with the implementation of new guidelines and new systems, come new challenges!

Vigilance is imperative around testing and validating your cloud to ensure patient privacy, data security, and quality practices, in addition to creating traceable records of every test and result to present to an auditor. With this in mind, if you’re wondering how to simplify validating your cloud in line with CSA and in a way that saves you both time and money, don’t miss this solutions-focused conference!

Speakers: Bryan Ennis, CEO and Co- Founder, Sware, Chris Clayton, Director of Information Technology, INCOG BioPharma Services, David Blewitt, Vice President, Cloud Compliance, USDM, Evjatar Cohen, Global Head of Life Sciences, ServiceNow, Harry Wolfgang, Senior Manager – Technology Regulatory Compliance, Johnson and Johnson Services, Ian Hambelton, Associate Director of IT Networks and Security, Replimune, Illena Armstrong, President, Cloud Security Alliance, Jean-Marc Jehl, Director, IT Quality, Risk and Compliance, Idorsia Pharmaceuticals, Jeremiah Genest, Head of Quality Management Systems, Amylyx Pharmaceuticals, John Andrews, Associate Director, Computer Systems Assurance, Chinook Therapeutics , Laura Estrada, Associate Director, GxP Computer System’s Compliance, Arcutis Biotherapeutics, Lisa Om, Vice President of Marketing, USDM, Manish Dwivedi, Information Technology Validation Manager, Takeda Pharmaceutical, Manu Vohra, Managing Director – Global Life Sciences, Box, Mikhael Dannan, IT and Tech Site Head, GlaxoSmithKline, Murali Mani, Chief Compliance and Privacy Officer, Sema4, Phyllis Fender, Senior Validation Manager, Regulatory Affairs and Quality Systems, Carestream Health, Praveen Malhotra, Vice President and Head of Information Technology, Sana Biotechnology, Radha Ramesh, Principal IT Specialist, Compliance, Ultragenyx Pharmaceutical, Randy Horton, Co-Chair of the Cloud Working Group and Technical Information Report, AAMI, Rob Morse, Director of Information Technology, Accent Therapeutics, Robert Smith, Project Manager, Schrodinger, Ryan Pehrson, Global Head of DevOps and Cloud, Takeda Pharmaceutical, Vishal Sharma, Vice President – Digital Trust and Transformation, USDM, Yves Samson, Member, ECA Data Integrity and IT Compliance Group