Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11: With Clear Recommendations for Corrective and Preventive Actions.

The new Part 11 regulation takes quite some time, but inspectors go out and focus inspections on computer systems and electronic-records for compliance with GMPs.

What will you learn:
- FDA inspections: Preparation, conducts, follow up
- The meaning of warning letters and 483 inspectional observations
- Learning from an FDA presentation: “Data Integrity and Fraud – Another Looming Crisis?”
- Data integrity: FDA’s new focus during inspections of computer systems and e-records
- Examples of recent Part 11 483′s and warning letters
- Examples of recent 483′s and warning letters related to computer system validation
- Most obvious reasons for deviations
- Responding to 483′s to avoid warning letters
- Writing corrective and preventive action plans to avoid 483′s
- The future of Part 11 and computer system validation

Who Should get?

* IT managers and personnel
* Everybody responsible for FDA compliance of computer systems
* Managers from purchasing, documentation and operations
* All users of computer systems used in regulated environments
* QA managers and personnel
* GLP/GMP/GCP auditors
* Consultants
* Teachers

Related posts:

1. Congress passed FDA Food Safety Modernization Act