This 60-minute webinar course answers the following questions:
This presentation aims at teaching participants about:
This course teaches you the auditor/inspector view of software development practices. It does not teach you how to develop software, but it does teach you how to provide documented evidence for quality gates in the software development process and formal testing practices.
Dr. Stokes has more than 20 years of experience auditing software suppliers on behalf of pharmaceutical clients and also helping software suppliers to establish auditable Quality Management Systems in their organizations to GCP/Part11/Annex 11 standards.
Dr. Teri Stokes has worked as a Medical Technologist in hospitals, researches, and central laboratories. Her transition to computers came from troubleshooting systems reporting laboratory results. She joined Digital Equipment Corporation (DEC) for a 16-year career focused on pharmaceutical computer solutions. Based in Basel, Switzerland 1990-1995, she developed DEC's computer validation consulting practice for customers across Europe and in Japan with a focus on reality-based compliance to global good practice (GCP, GLP, GMP) regulations.
Teri established her independent global consultancy in 1996 to coach validation teams, audit internal and external system suppliers, and train people on a common-sense approach to system compliance. She has satisfied clients in North America, Europe, Asia, and Africa. She has written three books and published many journal articles.