21 CFR Part 11 compliance for Electronic Medical Records
Instructor:
Alfonso Fuller
Product ID: 701217
- Duration: 60 Min
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.
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?
Who will benefit:
Companies that maintain electronic medical records. Personnel who will benefit include:- 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
Alfonso Fuller, is the founder and President of Fuller Compliance, a consulting firm that specializes in FDA quality system, software quality and software validation for pharmaceutical, biotech and medical device companies. Al is the author of several white papers, has spoken at numerous seminars, and has represented many clients before FDA compliance and enforcement personnel, and actively consults on day-to-day compliance issues.
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