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RCA in the Laboratory 2022 - Root Cause Analysis (RCA) in the Laboratory – Addressing Non-Conformances



VenueOnline, Online Online

KeywordsMedical Devices; FDA; RCA


Topics/Call fo Papers

Root Cause Analysis (RCA) in the Laboratory – Addressing Non-Conformances
Product Id : FDB2543
Category : Clinical & Laboratory, FDA Compliance, Food, Drugs & Biologics
Presenter : Michael Brodsky
Scheduled On : February 16 2022 12:00 pm
US/Canada (Eastern Time - ET)
Duration : 60 Minutes
How would you approach a non-conformance in the laboratory?
Do you start treating the symptoms right away? Or, do you take a moment to analyze and consider if there’s actually a deeper problem that needs your attention?
Root Cause Analysis (RCA) is one of the most commonly used techniques that helps people answer the question of why the problem occurred in the first place.
If you only fix the problem and symptoms – what you see on the surface without actually digging deeper to understand the problem – the problem will almost certainly happen again. This will lead you to fix it, again, and again, and again. If, instead, you spend time to analyze why the non-conformance is occurring, you can fix the underlying systems and processes once and for all ensuring similar problems do not creep up again.
Areas Covered in the Session :
Defining the Problem
Examining the Data
Identifying Possible Causal Factors
Identifying the Root Cause(s)
Taking Corrective Action
Verifying the effectiveness of the corrective action
Who Should Attend:
Microbiology QA Managers
Microbiological QC Analysts
QA/QC Managers/Supervisors
Laboratory Managers/Supervisors
Personnel responsible for QC and resolving non-conformances

Last modified: 2022-02-08 19:24:55