Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation 2015
11 Jun 2015
Webinar
Description
Topics
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
Who should Attend
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
Past Events
Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation 2015 - 11 Jun 2015, Webinar (51194)
Important
Please, check "Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation" official website for possible changes, before making any traveling arrangements
