Using SharePoint as a Technology Platform for 21 CFR part 11 - A Case Study 2014

Topics

• Description of the Biotech company used for the Case Study
• 21 CFR part 11 considerations
• Data Center Design and Data Center Qualification
• IT Controls - Systems that support PPP, Policy, Plans, and Procedures
• Using SharePoint as a Compliance Platform - Regulatory Submissions, SOP and Training Management, Product Management, Clinical Trial Management, Electronic Signature System
• Document Management System Selection
• System Validation - Establishing a process for system validation, Computer System Master Validation Plan

Who should Attend

• COOs
• CIOs
• Project Managers
• IT Directors, IT Managers
• CFOs
• Business Unit Mangers
• Document Managers and Knowledge Managers
• QA and QC Directors/Managers