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Corrections, Investigations and CAPA Details in Medical Device Setting


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Corrections, Investigations and CAPA Details in Medical Device Setting Webinar

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Corrections, Investigations and CAPA Details in Medical Device Setting

  1. 1. November Webinar: CAPA Details, Implementation and Q&A in MedicalDevice Setting by Connie Dello BuonoOur 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 OBJECTIVESThroughout 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.AUDIENCECAPA is appropriate for individuals who are regularly called upon to resolveproblems, or whose input would aid in preventing problems. Examples includeinvestigators, laboratory, QA/RA functions, managers, manufacturing supervisors,technicians, and engineers.This course will not only focus on CAPA, but on how to conduct investigationsincluding non-conformances, customer complaints, out of specifications, or anyother investigations you may face within your organization.
  2. 2. SpeakerConnie Dello Buono is a QA consultant in Northern California since 1994 withcompanies such as Varian Medical, Roche, Applied Biosystems, Lifescan andother medical device companies. She held a position such as CAPA coordinator,Document Control and Quality Assurance and Regulatory Affairs. She can bereached at or her blog 408-854-1883