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Effective URL: https://www.eventura.site/courses/3-hour-virtual-seminar-on-successful-deviation-investigations?utm_source=serversmtp&utm_...
Submission: On October 09 via api from IE — Scanned from DE
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Eventura World * Eventura World * Courses * MEMBERSHIP PROGRAMS * * Eventura World * * * Eventura World * Courses * MEMBERSHIP PROGRAMS * __ * Webinars * HRM ESSENTIALS 1. Eventura World 2. Courses 3. 3-HOUR VIRTUAL SEMINAR ON SUCCESSFUL DEVIATION INVESTIGATIONS 3-HOUR VIRTUAL SEMINAR ON SUCCESSFUL DEVIATION INVESTIGATIONS -------------------------------------------------------------------------------- -------------------------------------------------------------------------------- FACULTY: DANIELLE DELUCY Scheduled Date : October 05 2021 Scheduled Time : 11am - 2pm ET Description This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. This webinar will focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Learn how to identify and avoid potential pitfalls during deviation investigations. Areas Covered in the Session : * Review of FDA and Regulatory Requirements for Investigations * What is the definition of a Deviation? * Types of Deviations/Identification of Deviations * Conducting the Investigation * Interviews - do's and don'ts * Source Documents/Evidence * Determining Root Cause and Effective/Sustainable CAPA to avoid 483 observations * Key Elements of the Investigation Report Who Should Attend : * Deviation Investigators * Reviewers and Approvers of Deviation Investigations * Quality Assurance Departments * Regulatory Affairs Departments * Quality Control Departments * Compliance Auditors -------------------------------------------------------------------------------- Successful Deviation Investigations Danielle DeLucy FDA CAPA * * * * FDA INSPECTION ESSENTIALS IN 2021 3-HOUR VIRTUAL SEMINAR ON IQ, OQ, PQ IN THE VERIFICATION AND VALIDATION PROCESS HUMAN FACTORS USABILITY STUDIES FOLLOWING ISO 62366 AND NEW FDA GUIDANCE Eventura World Copyright © 2021 All rights reserved Powered By SITE123 - Website maker * Eventura World * Courses * Webinars * HRM ESSENTIALS * more * MEMBERSHIP PROGRAMS