05/12/2017 11:30 AMTraining Topic: 21 CFR Part 11 compliance for Electronic Medical RecordsInstructor: Alfonso Fuller
Objectives of the Presentation
Review of current status of 21 CFR Part 11
What is the relationship between "validation" and "part 11 compliance" to electronic medical records?
What do I have to do today to be in compliance?
What changes can I expect to see in Part 11?
When will I need to be in compliance?
What is the future part 11 likely to look like?
How can I best integrate part 11 compliance into my quality system?
How can I ensure what I do today will stand inspection tomorrow?
Why Should you Attend
Electronic Medical Records are the future. Some facilities and doctors are already using this cutting edge technology and the medical community in general is moving in this direction.
FDA regulations governing electronic records and electronic signatures will be enforced upon these systems as they are used and become more prevalent. This presentation analyzes the regulations and provides concrete guidance on compliance.
Who will Benefit
Management responsible for operational and quality systems (system owners)
QA Directors, Managers and personnel
IT / IS managers and personnel
Software validation and software quality managers + personnel
Consultants charged with creating or evaluating part 11 programs
Programmers, developers, project managers and others responsible for bringing systems online in a compliant manner
Quality auditors responsible for auditing and evaluating part 11 compliance
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