2023 - MASTER THE VENDOR AUDITING OF YOUR COMPUTER SYSTEMS REGULATED BY FDA
VenueOnline Event, Canada
KeywordsCSV; Auditing; FDA; Medical Device; vendor
Topics/Call fo Papers
This webinar will provide the best industry practices to follow when auditing a vendor of a computer system that is regulated by FDA. We will discuss the best approach for assessing a vendor’s organization, capability, physical/logical security practices, requirements, code development/management practices, version control, change control, compliance with 21 CFR Part 11 (electronic records/electronic signatures), testing, operations management, disaster recovery, document management, and customer service. A template and checklist are provided for use in conducting vendor audits. These will help guide you through the process and ensure you fully assess the vendor’s capability.
Last modified: 2023-06-08 18:24:29