BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T093214Z UID:9269f9bc-2206-438e-a10c-139b4afc20d2 DTSTART:20210521T120000 DTEND:20210522T120000 CLASS:PRIVATE DESCRIPTION:
Overview
\n\nDeviations and Non-confo rmances are enviable. The key is utilizing those events as an avenue to im prove the overall quality system. Thorough Root Cause Analysis is essentia l to correcting and preventing issues. RCA is a systematic approach that u tilizes quality tools to objectively identify factors that have resulted i n or could contribute to a deviation.
\n\nOnce the RCA identifies th e factors that caused the event\, proper generation of CAPA actions is cri tical to maintaining a healthy quality system. The regulatory agencies ful ly expect to see documented root cause analysis that resulted in both corr ective and preventative actions.
\n\n \;
\n\nPart 1 &ndash\; How to Pe rform a Thorough Root Cause Analysis (RCA)
\n\n&bull\; Unde
rstand Regulatory and Industry Guidance \;
\n&bull\; What is Root
Cause Analysis?
\n&bull\; When Should Root Cause Analysis be perform
ed?
\n&bull\; Discuss several Root Cause Analysis Methodologies
\n&bull\; Discuss common errors that occur during RCA
Pa rt 2 &ndash\; Developing Appropriate Corrective and Prevention Actions (CA PA)
\n\n&bull\; Understand Regulatory and Industry Guidance
\n&bull\; Discuss the difference between Correction\, Corrective Act
ion\, and Preventive Actions
\n&bull\; Understand How to Develop robu
st CAPA records\; including effectiveness checks
\nPart 3 &ndash\; Review Real Life Case Studies
&bull\; Discuss recent Regulatory observations in regards to insufficient investig ations and CAPAs records.
\n\n \;
\n\nWho Will Benefit
\n\nOperations \;
\nFacilities \;
\nEngineering
\nQuality Assurance \;
\nQC Managers
\nQuality Engineers