Implementing an effective system for corrective action and preventive action can be a major challenge. FDA illustrates the point in device Warning Letters. Since 2008, CA&PA has been the most frequently cited QSR section; about 70% of all Warning Letters includes a citation to §820.100. When expanded to the larger system in which the FDA includes nonconforming material, corrective and preventive action, and complaints, the situation gets worse.
This interactive two-day course provides the tools you need to develop and implement an effective medical device CA&PA system. In addition to FDA QSR, the course covers the corresponding requirements in ISO 13485:2016, linkage to risk management in ISO 14971:2007, and MDSAP Audit Tasks. Corrective action requirements can extend beyond the QMS to include field actions, so the course includes adverse event reporting, Corrections & Removals, Field Safety Corrective Actions, and Field Safety Notices.
CA&PA does not stand alone; it is most effective when it is an integral part of the Quality Management System and influences all of the other subsystems. The overarching objective of the course helps the participants develop the tools and methods. The course utilizes a broad variety of available material including Global Harmonization Task Force (GHTF) guidance documents, ISO guidance documents, and European Union medical device guidance documents (MEDDEV).
Learning Objectives:
- Develop the tools and methods to create an integrated CA&PA system.
- Explain the difference between correction, corrective action, and preventive action and understand why they are different.
- Gain knowledge of the medical device CA&PA regulatory requirements including FDA QSR and ISO 13485:2016.
- Evaluate common problem solving and improvement methodologies, explain the quality tools, and apply them to the CA&PA system.
- Understand "appropriate statistical methodology" to analyze data and identify existing and potential causes of quality problems.
- Identify the linkages between complaints, corrective action, and risk management.
- Understand the regulatory requirements for corrective actions in the field for both the US and the EU.
Who will Benefit:
While the course is specific for medical device companies, any company can benefit from an effective CAPA system. It is ideal for:
- Quality Managers
- Quality Engineers
- Regulatory professionals
- Operations Managers
- Manufacturing Engineers
- Risk Managers
- Complaint system team members
- CAPA team members
- 08.30 AM - 09.00 AM: Registration
- 09.00 AM: Session Start
- Lecture 1 – Understanding Correction, Corrective Action, and Preventive Action
- The Problem
- Definitions
- Laying Out the Language
- Effect on the QMS
- Lecture 2 – Quality System Regulation
- §820.90 Nonconforming product
- §820.100 Corrective and preventive action
- §820.198 Complaint files
- Lecture 3 – ISO 13485:2016
- 8.2.2 Complaint handling
- 8.3 Control of nonconforming product
- 8.5.2 Corrective action
- 8.5.3 Preventive action
- Lecture 4 – The GHTF Guidance
- Planning
- Measurement and Analysis – Data Sources
- Improvement
- Input to Management
- Lecture 5 – Implementing the CA&PA Requirements
- Determining the Cause
- Determining the Action to Take
- Implementing the Action
- Potential Adverse Effects
- Checking Effectiveness
- Lecture 6 – Auditing CA&PA
- QSIT
- MDSAP
- Lecture 7 – Quality Tools
- Flowcharts
- Cause and effect diagrams
- 5 Why Analysis
- Check Sheets
- Pareto charts
- Is/Is Not Analysis
- Lecture 8 – Statistical Tools
- Descriptive Statistics
- Sampling
- Hypothesis testing
- Time series analysis
- Statistical Process Control
- Process Capability Analysis
- Regression analysis
- Lecture 9 – Complaints and CA
- Defining a Complaint
- Investigating a Complaint
- Taking Corrective Action
- Updating the Risk Management File
- Lecture 10 – Adverse Event Reporting and Field Actions
- US – MDRs
- US – Corrections and Removals
- EU – Vigilance
- EU – FSCA & FSN
Dan O'Leary
President at Ombu Enterprises, LLC
Dan O'Leary has more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. Mr. O’Leary has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.
He is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. He is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.
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Testimonials
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Quality Specialist, Rochester Medica
Quality Manager, Parker Hannifin Corp
Compliance Coordinator, Diagnostica Stago, Inc.
Senior Quality Assurance Engineer, NDI Medical LLC
Quality Engineering Manager, ConvaTec Inc.
Director of Research and Development, Metrex Research,LLC
Manager, Quality Assurance, Instrumentation Laboratory
Director of Operations and Quality, NDI Medical LLC
Sr. CAPA Specialist, Johnson & Johnson Vision Care Inc
Quality Director, Lifecore Biomedical
QA/RA Representative, ResMed Corp
Quality Assurance, Beckman Coulter
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