21 CFR Part 11: Complying with Part 11 Regulation - Understanding the Predicate Rule 2012

Topics

• 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

Who should Attend

• Quality Engineers
• Quality Managers
• Internal and External Auditors
• Small Business Owners
• FDA Inspectors
• Management Reps
• Consultants