The “Software/Firmware Validation in Production/Test Equipment, Devices, and the QMS, and Cybersecurity” webinar will address a field-tested “model” for Verification and Validation of software and firmware in manufacturing and test equipment, in or as a device, and as part of a quality system, subject to 21 CFR 11. Documentation accepted by both the U.S. and the EU will be presented. The most recent guidance from the U.S. FDA on cybersecurity will also be addressed. It evaluates what the company should require of each category software-controlled equipment/devices in terms of validation, verification, preventive maintenance, calibration, re-V&V, et al. The webinar will discuss working V&V definitions, the supporting documentation addressed by such a plan, including the structure of V&V Test Reports, IQ, OQ, and PQ (or equivalent) Test Cases. And how “risk-based” incorporates patient risk (ISO 14971, ICH Q9) into such V&V plans.
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Email: webinar@247compliance.com
Toll Free: +1-510-868-1040
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