Overview of the Part 11 regulation; Description of HOW TO ensure compliance with Part 11; Internal and External audits for compliance with Part 11; Key terms and definitions; Example of solid compliance; Examples of non-compliance; Examples of Warning Letters; Tools for compliance; Further readings, trainings and opportunities related to Part 11.
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.
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 than 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
Who Will Benefit:
- Overview of the Part 11 regulation
- Description of HOW TO ensure compliance with Part 11
- Internal and External audits for compliance with Part 11
- Key terms and definitions
- Example of solid compliance
- Examples of non-compliance
- Examples of Warning Letters
- Tools for compliance
- Further readings
- trainings and opportunities related to Part 11
- Quality Managers
- Quality Engineers
- Small Business Owners
- Internal and External Auditors
- Management Reps
- FDA Inspectors