This 21 CFR Part 11 training will analyze the regulations and provides concrete guidance on compliance for Electronic Medical Records.
Learning Objectives:
- 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.
Instructor
Alfonso Fuller is the President of Fuller Compliance, Inc., a consulting firm that specializes in FDA quality system, software validation and software quality for pharmaceutical, biotech and medical device, nutraceutical and food manufacturers.
He is a consultant, writer, and frequent presenter nationwide on quality system and software quality issues. His speaking appearances have included numerous national and statewide conferences.