As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by industry on compliance rather than quality may be diverting resources and management attention toward meeting regulatory compliance requirements vs. adopting best quality practices for validation of computer systems using newer technologies. This online masterclass will take a deep dive into the mechanics, documentation, and compliance requirements for completing a validation effort, whether you choose to follow CSV or CSA, waterfall or agile, or any other type of approach. #webinar
Key learnings:
Learn about FDA
Computer System Validation
Cloud Computing & SaaS
Integrity of Data
Regulatory Influences
Agile vs. Waterfall Approach