Managing Nonconformances, Investigations, and CAPAs in Life Sciences

Managing nonconformances, investigations, and CAPAs in Life Sciences: the full process from first observation to closure. https://simplerqms.com/capa/ Nobody wants a CAPA, but things do go wrong, and a nonconformance is not an admission of failure: it shows your quality system is working. The common problems are weak traceability between investigations and actions, root cause analysis that stops at symptoms, and CAPAs left open without clear actions or effectiveness checks. In this webinar, Thomas Tschirhart, Director of Sales at SimplerQMS, walks through the full process, from the first observation to a closed CAPA. SimplerQMS provides a fully validated eQMS software solution built exclusively for Life Science companies: https://simplerqms.com/ WHAT IS CAPA? Corrective and Preventive Action (CAPA) is a systematic approach designed to identify, resolve, and prevent the recurrence of recorded problems, such as deviations, nonconformances, audit findings, and complaints. Read more: https://simplerqms.com/capa/ WHAT IS A NONCONFORMANCE? A nonconformance is any deviation from a specified requirement, procedure, specification, or standard. Read more: https://simplerqms.com/non-conformance/ YOU'LL LEARN Why not every observation becomes a quality event How to document a nonconformance so an auditor can follow it How to assess product, patient, and regulatory impact How to run an investigation: define the problem, gather evidence, and find the root cause (5 Whys, fishbone) When to open a CAPA, and when to link an event to an existing one How to set specific actions, owners, and timelines so CAPAs close How to define and verify CAPA effectiveness DEMO CAPA records root cause investigation, action plans, owners, due dates, and effectiveness verification in one closed-loop record. In SimplerQMS, Life Science eQMS software, you can log observations from the floor, escalate them to a nonconformance, link related records, and track CAPA actions with evidence through to closure. WHO IT'S FOR QA/RA professionals, quality managers, and QMS owners at Life Science companies (medical device, biotechnology, pharmaceutical, in vitro diagnostics, and CRO/CMO) working under ISO 13485:2016, FDA 21 CFR Part 820, or FDA 21 CFR Parts 210 and 211. CHAPTERS 0:00 Introduction 1:20 What this webinar covers 2:00 Common nonconformance and CAPA challenges 3:34 Not every observation is a quality event 3:57 What is a nonconformance? 4:57 How to identify and document a nonconformance 6:04 Assessing impact, risk, and recurrence 7:33 Investigations and root cause analysis 9:01 When to initiate a CAPA 11:14 Running a CAPA: actions, owners, and timelines 12:25 Verifying CAPA effectiveness 13:34 How it all connects: from observation to CAPA 14:36 SimplerQMS demo: CAPAs and quality events 16:03 Demo: observations and "see something, say something" 18:12 Demo: nonconformance record, impact, and root cause 20:04 Demo: CAPA actions, evidence, and closure 22:27 Q&A: Can closed events be accessed and reopened? 23:46 Q&A: Do I need to be in QA to report an event? 24:39 Q&A: Does every report become a CAPA? 25:16 Q&A: Can workflow transitions be configured? 26:16 Q&A: How long does implementation take? 27:30 Q&A: Are observations part of an ISO audit? 28:24 Q&A: How are reviewers and approvers assigned? 29:17 Q&A: How do I see a nonconformance's status? 29:58 Try the interactive product tour READ NEXT CAPA procedure: process steps and example: https://simplerqms.com/capa-procedure/ FREE DOWNLOADS CAPA form template: https://simplerqms.com/resources/capa... Nonconformance report (NCR) template: https://simplerqms.com/resources/non-... Interactive product tours: https://simplerqms.com/resources#prod... ABOUT SIMPLERQMS SimplerQMS is a fully validated eQMS software built exclusively for Life Science companies - pharmaceutical, biotechnology, medical device, in vitro diagnostics, and contract research organizations. The platform connects document control, training, change control, CAPA, nonconformances, audits, supplier control, design control, and risk management in one cloud-based system, so every quality record stays linked and traceable. SimplerQMS is fully validated according to ISPE GAMP 5, covering Installation Qualification, Operational Qualification, and Performance Qualification, which removes computer system validation work from the customer's scope. Implementation, training, hosting, and support are included in the subscription. Learn more: https://simplerqms.com/ Book a demo: https://simplerqms.com/book-a-demo/ Start a free trial: https://simplerqms.com/free-trial/ Upcoming webinars: https://simplerqms.com/webinars/ LinkedIn:   / simplerqms   This webinar was recorded live on Livestorm. Content is for general information and is not regulatory or legal advice. #CAPA #Nonconformance #LifeSciences