21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection
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 FDA inspections, yet most organization do not know how to best prepare for such inspections.
In a time of global economy when and where time is of essence, having an ability to accessÂ 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 for an FDA inspection
- When and Where Part 11 is in scope or the scope of the inspection;
- Detailed description of HOW TO handle the FDA inspection during the inspection itself;
- Some trends when it comes to Part 11 inspections;
- Commonly asked questions; warning letters examples; and what the future holds when it comes to Part 11.
Who Will Benefit:
- Quality Managers
- Quality Engineers
- Small business owners
- Internal and external auditors
- Management Reps
- FDA inspectors