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Corrections, Investigations and CAPA Details in Medical Device Setting
1. November Webinar: CAPA Details, Implementation and Q&A in Medical
Device Setting by Connie Dello Buono
Our CAPA course teaches the following key process skills:
ďˇ Issue Review - Identify and prioritize non-
conformances based on risk.
ďˇ Root Cause Analysis - Investigate systemic
issues for underlying cause.
ďˇ Implementation & Effectiveness Checking -
Solution selection, verify and validate,
implement, monitor and confirm success.
LEARNING OBJECTIVES
Throughout the workshop, attendees improve their ability to:
ďˇ Gather relevant information on problems
through specific, focused questioning.
ďˇ Pinpoint root causes using facts instead of
guesswork or opinion.
ďˇ Avoid costly experiments and trial fixes by
logically testing possible causes.
ďˇ Assess and prioritize each nonconformance
based on risk
ďˇ Target potential problems before they happen
and develop actions to prevent them.
ďˇ Check effectiveness of corrective actions.
ďˇ Document the analysis in an easy-to-use
format.
AUDIENCE
CAPA is appropriate for individuals who are regularly called upon to resolve
problems, or whose input would aid in preventing problems. Examples include
investigators, laboratory, QA/RA functions, managers, manufacturing supervisors,
technicians, and engineers.
This course will not only focus on CAPA, but on how to conduct investigations
including non-conformances, customer complaints, out of specifications, or any
other investigations you may face within your organization.
2. Speaker
Connie Dello Buono is a QA consultant in Northern California since 1994 with
companies such as Varian Medical, Roche, Applied Biosystems, Lifescan and
other medical device companies. She held a position such as CAPA coordinator,
Document Control and Quality Assurance and Regulatory Affairs. She can be
reached at motherhealth@gmail.com or her blog at
www.clubalthea.wordpress.com 408-854-1883