Software verification and validation problems have been the subject of numerous FDA warning letters and inspectional observations – learn how to comply with requirements to protect your organization from costly and dangerous safety and reliability issues.
Learn the fundamentals needed to understand and comply with ISO 9001, ISO 13485, and the FDA’s QSR requirements for verification and validation of computerized systems. Discussions cover linked quality systems and business processes in the context of software applications for medical device and diagnostic industries.
Target Audience: Recommended for computer system/software users, mid-level managers and systems developers, engineers, and quality assurance professionals in the medical device fields.