2015 - Webinar On Computer System Validation: Step-by-Step

Description :
The validation of computer system has been an FDA requirement since more than 20 years. Nevertheless companies have problems with implementation. This is proven through many FDA warning letters related to software and computer system validation, especially in the last three years. Validation professionals know the principles but have problems with implementation, especially with the development of protocols. This seminar will give a good understanding of FDA requirements for computer system validation and provide steps for cost-effective implementation.
For easy implementation, attendees will receive
SOP: Validation of Commercial Off-the-Shelf Computer Systems
SOP: Development and Maintenance of Test Scripts for Software and Computer Systems
Checklist: Using computers in FDA regulated environments
Areas Covered in the Session :
US FDA and EU requirements and enforcement practices
Learning from recent FDA 483's and warning letters
Selecting the right validation model: qualification vs. verification
Eight fundamental steps for computer system validation
Structure and example of a validation plan
Justification and documentation of risk levels
Example qualification document for suppliers of commercial systems
Examples for requirement and functional specifications?
Example for IQ protocols
OQ test protocols: development, execution, approval - examples
Documentation of ongoing performance
Validation of existing systems
Structure and example of a validation report
Step-by-step case studies from laboratories and manufacturing for easy implementation
Who Will Benefit:
A must attend webinar for professionals in Pharmaceutical and medical device industry, Manufacturers of pharmaceutical ingredients and Contract manufacturers and laboratories. The teams that will benefit the most are:
IT managers and system administrators
QA managers and personnel
QC Lab managers and üersonnel
Validation specialists
Regulatory affairs
Training departments
Documentation department
Consultants