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.