2017 - FDA Computer System Validation Steps

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.
Learning Objectives :
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 :
QC managers
QA managers and personnel
IT administrators
Regulatory affairs
Training departments
Validation groups
Documentation department
Consultants
Instructor Profile :
Ludwig Huber, Ph.D., is the director of Lab compliance and editor of www.labcompliance.com, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11, and Validation around the world. This included seminars, workshops and presentations for the US FDA, China CFDA, , ISPE, Japan PDA, PIC/S and several other national health care agencies. For more information, please visit Dr.Huber’s website www.ludwig-huber.com.