This presentation will cover following topics:
Regulatory requirements for IT Infrastructure in Pharma, Lifesciences and Health industries
· Components of IT Infrastructure and Qualification
· Inhouse versus Cloud IT Infrastructure
· Types of Cloud models
· Roles and Responsibilities
· Benefits of Cloud
· Challenges and Risks in Cloud adoption.
· Cloud Security
· Compliance standards for Cloud
· Auditing of Cloud vendors
· Cloud Transformation - New systems deployment versus old systems migration – Step by step process
· Risk based approach for Data Migration to Cloud with GxP compliance
· Service Level Agreements and Support
· Capacity Planning and Upgrade
· Periodic Reviews
Sharmila Valleru is a Director in PwC India, leading the CSV Practice. She is a Subject Matter Expert and a Senior Quality and Regulatory Compliance with more than two decades of experience. She has been assisting Pharma & Lifesciences and Medical Devices companies in the areas of CSV, GxP and IT Compliance. She had assisted both domestic and international companies in the Audits / Gap assessments, Remediations, Training, Automation & Digitalization.
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