21 CFR Part 11 compliance for Electronic Medical Records (21 CFR Part 11 Compl)
Venue: Online Event
|Event Date/Time: May 30, 2012||End Date/Time: May 30, 2012|
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.
Areas Covered in the seminar:-
- 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?