21 CFR Part 11: Complying with Part 11 Regulation - Understanding the Predicate Rule 2012 is a webinar that covers topics such as:
- Description of HOW TO ensure compliance with Part 11
- Overview of the Part 11 regulation
- Key terms and definitions
- Internal and External audits for compliance with Part 11
- Examples of non-compliance
- Example of solid compliance
- Tools for compliance
- Examples of Warning Letters
- Trainings and opportunities related to Part 11
- Further readings
21 CFR Part 11: Complying with Part 11 Regulation - Understanding the Predicate Rule 2012 brings together:
- Quality Engineers
- Quality Managers
- Internal and External Auditors
- Small Business Owners
- FDA Inspectors
- Management Reps
- Consultants
