Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation 2015 is a webinar that covers topics such as:
- The meaning of Warning Letters and 483 inspectional observations
- FDA inspections - preparation, conducts, follow up
- Data integrity and authenticity: FDA`s new focus during inspections
- Learning from an FDA presentation: Data Integrity and Fraud - Another Looming Crisis?
- Examples of recent 483s and Warning Letters related to computer system validation
- Examples of recent Part 11 related 483s and Warning Letters
- Avoiding and responding to 483s: going through case studies
- Most obvious reasons for deviations
- Using internal audits to prepare yourself for Part 11 related FDA inspections
- Writing corrective and preventive action plans as follow up to 483s
- The future of Part 11 and computer system validation
- Strategies and tools for compliant Part 11 implementation
Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation 2015 is intended for:
- Manufacturers of drug substances (APIs)
- Personnel from the pharmaceutical and medical device industry
- Employees using computers in FDA regulated environments
- Contract laboratory staff
- QA managers and personnel
- IT managers and staff
- Regulatory affairs personnel
- Quality control directors or delegates
- Consultants
- Training department personnel
- Validation specialists
