The Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 is a webinar that covers topics such as:
- The meaning of warning letters and 483 inspectional observations
- FDA inspections: Preparation, conducts, follow up
- FDA`s new focus during inspections of computer systems and e-records
- Learning from an FDA presentation: "Data Integrity and Fraud - Another Looming Crisis?"Data integrity
- Examples of recent 483’ and warning letters related to computer system validation
- Examples of recent Part11 483’s and warning Letters
- Responding to 483`s to avoid warning letters
- Most obvious reasons for deviations
- The future of Part 11and computer system validation
- Writing corrective and preventive action plans to avoid 483
The Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 brings together Part 11 groups in Bio(pharmaceutical) and device industry, Pharmaceutical, API and Medical Device Industry, IT managers and system administrators, Software developers, Analysts and lab managers, QA managers and personnel, Training departments, Validation professionals, Consultants and Documentation department.
