Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 2011
29 Jul 2011
Webinar
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.
Past Events
Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 2011 - 29 Jul 2011, Webinar (17418)
Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 2026
Important
Please, check "Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11" official website for possible changes, before making any traveling arrangements
Event Categories
Education: Education Technologies & Methods
Health & Medicine: Medical device, Medical laboratories, Medical technology, Pharma
