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VERSION:2.0
PRODID:icalendar-ruby
CALSCALE:GREGORIAN
BEGIN:VEVENT
DTSTAMP:20240328T210239Z
UID:81ad62bb-5805-4ee6-a815-913c0912e6c9
DTSTART:20210608T133000
DTEND:20210609T133000
CLASS:PRIVATE
DESCRIPTION:Overview
\nProblem solving is critical to
successfully maintaining and improving pharmaceutical and biotech process
es. Processes are dynamic and as predicted by the 2nd law of thermodynamic
s will deteriorate over time if left alone. Federal Regulation Title 21 re
quires that an organization&rsquo\;s quality system include a process for
Corrective and Preventive Action. Central to an effective CAPA system is t
he identification of root causes of problems. Systematic approaches for pr
oblem solutions have been called for but few have appeared. Problem and de
viation solutions tend to be handled individually. The frequent result is
root causes are not identified and the problems reoccur.
\nA systemat
ic approach based on process and systems thinking and the DMAIC problem so
lving and improvement framework is presented\, discussed and illustrated.
The focus is on getting to root cause and putting permanent fixes in place
so that the problems do not occur again. The concepts and methods involve
d to meet these objectives are introduced and illustrated with pharmaceuti
cal and biotech case studies and examples.\n
Session Highligh
ts\n\n\n - What is Root Cause Analysis?
\n - Current
Approaches: Strengths\, Limitations and Tools
\n - Systematic approa
ch &ndash\; Roadmap and Tools
\n - Use of Define\, Measure\, Analyze
\, Improve and Control (DMAIC) problem solving model
\n - Solving sy
stem failure problems
\n - Integrating Corrective Action and Prevent
ion
\n - Sustaining the Elimination of Root Cause
\n - Importa
nce of Periodic Management Review
\n - Systematic Approach for Devia
tion Reduction
\n - Tips\, Traps and guidelines for successful root
cause analysis\n
\n  \; \n
\nLearning Obje
ctives
\n
\n&bull\; Understand the Strengths\, Limitati
ons and Tools of current Approaches to Root Cause Analysis
\n&bull\;
Systematic Approach to Root Cause Analysis: \;
\no What it is\, W
hy it is Needed and How to Implement the Approach \;
\n&bull\; Ho
w to Sustain the Elimination of Root Cause and the \;
\no Importa
nce of Periodic Management Review
\n&bull\; Tips\, Traps and guidelin
es for successful root cause analysis\n
\n
\nWho W
ill Benefit\n\n\n - Production Managers
\n - Quality
Assurance Managers\, Scientists and Engineers
\n - Research and Deve
lopment Scientists
\n - Product Development Personnel
\n - Lab
Testing Personnel
\n - Biologists and Microbiologists
\n - Ch
emists and Chemical Engineers
\n - Process and Manufacturing Enginee
rs
\n - Quality Engineers
\n - Supply Chain Professionals
\n - Process Improvement Professionals
\n
\n
SUMMARY:Root Cause Analysis for CAPA Investigations A Systematic Approach L
ive
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SUMMARY:Root Cause Analysis for CAPA Investigations A Systematic Approach L
ive
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