21 CFR Part 11: Auditing for Part 11 Compliance
21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries.
Why Should You Attend:
More and more organizations are striving to "go green" and develop "sustainable" organization's strategies, which almost always includes using more and more of the computer technologies. Part 11 is a regulation that regulates the technology when it comes to electronic signatures and electronic records and will be more then ever a part of the scope of the INTERNAL AND EXTERNAL audits yet most organization do not know how to best prepare and execute such audits.
In a time of global economy when and where time is of essence, having an ability to access records from any location around the world is more critical then ever, and for the same reason, electronic records will be more needed and desired in each organization. In addition, approval of documents and records in a timely fashion is absolutely needed at all times, and being able to do just that via an electronic media is understood. For both, electronic signatures and electronic records, the organization shall comply with the Part 11 regulation.
Areas Covered in the Session:
- Short and quick overview of the Part 11 regulation
- Detailed description of HOW TO prepare internal and external audits
- Schedules to include Part 11 audits
- How to prepare for a specific audit that includes Part 11 regulation
- Difference from other quality audits
- Training requirements, good practices and commonly asked questions
- warning letters examples; and what the future holds when it comes to Part 11
The focus is on DIFFERENCE between regular QMS audits in audits when Part 11 is in scope of the audit - from auditors; regulations; training; preparation; execution; follow up and other standpoints.
Who Will Benefit:
- Quality Managers
- Quality Engineers
- Small business owners
- Internal and external auditors
- Management Reps
- FDA inspectors