The main objectives of this course are to give attendees a grounding in the principles of Software Validation, Computer Systems Validation and the latest requirements for Electronic Records and Electronic Signatures. The course provides an overview of the FDA and European requirements with practical exercises covering the implementation of those requirements. The course covers the application of these requirements to the validation of both computer hardware and software systems used in Manufacturing, QA, Regulatory and the Control of Processes. The course also covers the latest FDA Requirements and Guidance on Electronic Records and Signatures (21 CFR Part 11) and Quality Risk Management as applied to Software Validation and Computer Systems Validation.+- Collapse
9:00am to 4:30pm
(includes course documentation).
With the transition of many medical device companies to ISO 13485:2016 “Medical Devices – Quality Management Systems – Requirements for regulatory purpose...