GxP Computer Systems Validation: The Investigator's Point of View

GxP - Good Clinical, Laboratory, and Manufacturing Practice - are guidelines ("predicate rules") derived from international standards adopted by the US FDA as benchmarks for the regulation of drug and device clinical trials. With respect to the validation of computer systems used in all types of FDA-regulated research activities, the implications of GxP have been distilled into a few key documents. In this presentation, we will look at these documents from the investigator’s point of view, reviewing the FDA training manual and actual FDA warning letters and responses. This will reveal what the investigator is trained to look for and what types of problems are actually being discovered in the field offices.

Areas Covered in the seminar:

• What are the GxP predicate rules and the standards from which they originate?
• What kinds of computer systems are found in the context of regulated research activities?
• What does the FDA mean by the term validation?
• What documents are publicly available that describe computer systems validation?
• Regulations applicable to computer systems validation.
• Validation as proactive quality assurance.
• What is the investigator trained to look for in assessing validation?
• By what criteria is the investigator trained to evaluate the state of computer systems used in research activities?
• Validation activities: common sense or nonsense?
• Letters from the field, part 1: What problems are investigators targeting?
• Letters from the field, part 2: How are drug and device manufacturers responding to computer systems validation related warnings?
• Planning a comprehensive strategy.

Who Will Benefit:
This webinar will help executives and managers of pharma and biotech organizations understand the FDA computer systems validation perspective and how to identify and address validation requirements in activities under their control. Personnel who will benefit include:

• Executives of pharma and biotech companies
• Managers of FDA-regulated pharma and device manufacturing and research operations
• IT staff actively or potentially involved in computer systems validation activities
• Data center managers and administrators hosting and administering computer systems and applications used in FDA-regulated research activities

Instructor Profile:
Dale Hunscher , MSI, is a senior systems analyst at the Michigan Institute for Clinical and Health Research at the University of Michigan, where he specifies and oversees the design and development of clinical research data management systems and conducts technology strategy analyses for Health System leadership. He has 24 years experience in commercial and enterprise software development, including two years in pharmaceutical publishing and four years in clinical research.