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Effective URL: https://email.axonstechnology.com/caro-0053/
Submission: On March 24 via api from US — Scanned from DE
Effective URL: https://email.axonstechnology.com/caro-0053/
Submission: On March 24 via api from US — Scanned from DE
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ONLINE WEBINAR DEVELOPING A STRATEGIC APPROACH TO FDA COMPLIANCE FOR COMPUTER SYSTEMS This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. BOOK YOUR SPOT MEET CAROLYN TROIANO Computer System Validation Expert Carolyn has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco, e-cigarette/e-liquid, and other FDA-regulated industries. WHAT WILL YOU LEARN * System Development Life Cycle (SDLC) Methodology * Computer System Validation (CSV) * Good “Variable” Practice (GxP) * Good Manufacturing Practice (GMP) * Good Laboratory Practice (GLP) * GAMP 5 Guidance for System Classification * Risk Assessment and Management * Validation Strategy * Change Control and Audit Trails * User Requirements Specification (URS) & Functional Requirements Specification (FRS) * System Design Specification (SDS) and System Configuration Specification (SCS) * Test Planning, Execution, and Documentation (IQ/OQ/PQ) * Requirements Traceability Matrix (RTM) * System Acceptance, Release Notification, and Deployment * System Retirement * Data Governance Archival BOOK YOUR SPOT OUR SERVICES : WEBINARS | SEMINARS | IN-PERSON TRAINING | PODCASTS | EBOOKS 10685-B Hazelhurst Dr.# 27262 Houston TX 77043 USA Copyright © 2020. GRC , All Rights Reserved.