FDA 21 CFR Part 11 - IT`s Role in Part 11 Compliance 2013

Topics

• Digital vs. Electronic signature
• Open vs. closed systems
• Systems that support IT Controls
• Core Policies, Plans and Procedures for IT Controls
• Components of a Computer Systems Master Validation Plan
• What is computer system validation?
• The importance of internal and external audits

Who should Attend

• COOs
• CIOs
• IT Managers
• IT Directors
• CFOs
• Business Unit Managers
• QA Directors/Managers