Corrections, Investigations and CAPA Details in Medical Device Setting Webinar

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:
 Issue Review - Identify and prioritize non-
conformances based on risk.
 Root Cause Analysis - Investigate systemic
issues for underlying cause.
 Implementation & Effectiveness Checking -
Solution selection, verify and validate,
implement, monitor and confirm success.
LEARNING OBJECTIVES
Throughout the workshop, attendees improve their ability to:
 Gather relevant information on problems
through specific, focused questioning.
 Pinpoint root causes using facts instead of
guesswork or opinion.
 Avoid costly experiments and trial fixes by
logically testing possible causes.
 Assess and prioritize each nonconformance
based on risk
 Target potential problems before they happen
and develop actions to prevent them.
 Check effectiveness of corrective actions.
 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