21 CFR Part 11 compliance for Electronic Medical Records 2017

Topics

• What is the relationship between "validation" and "part 11 compliance" to electronic medical records?
• Review of current status of 21 CFR Part 11
• What changes can I expect to see in Part 11?
• What do I have to do today to be in compliance?
• What is the future part 11 likely to look like?
• When will I need to be in compliance?
• How can I ensure what I do today will stand inspection tomorrow?
• How can I best integrate part 11 compliance into my quality system?

Who should Attend

• QA Directors, Managers and personnel
• Management responsible for operational and quality systems ("system owners")
• Software validation and software quality managers + personnel
• IT / IS managers and personnel
• Programmers, developers, project managers and others responsible for bringing systems online in a compliant manner
• Consultants charged with creating or evaluating part 11 programs
• Quality auditors responsible for auditing and evaluating part 11 compliance