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. 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 firstname.lastname@example.org or her blog atwww.clubalthea.wordpress.com 408-854-1883