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Investigating Deviations 2022 - Successfully Investigating Deviations



VenueOnline, Online Online

KeywordsFDA Compliance; Investigating Deviations; Medical Devices


Topics/Call fo Papers

Successfully Investigating Deviations
Product Id : FDB2161Category : Clinical & Laboratory, FDA Compliance, Food, Drugs & Biologics, Medical Devices
Presenter : Danielle DeLucy
Scheduled On : March 17 2022 1:00 pm
US/Canada (Eastern Time - ET)
Duration : 75 Minutes
Please follow the link to Register :
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 Will Benefit:
Deviation Investigators
Reviewers and Approvers of Deviation Investigations
Quality Assurance Departments
Regulatory Affairs Departments
Quality Control Departments
Compliance Auditors

Last modified: 2022-02-14 19:23:15