CA&PA for Medical Devices
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).
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.
DAY 01(8:30 AM - 4:30 PM)
08.30 AM - 09.00 AM: Registration
09.00 AM: Session Start
Lecture 1 – Understanding Correction, Corrective Action, and Preventive Action
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
Measurement and Analysis – Data Sources
Input to Management
Lecture 5 – Implementing the CA&PA Requirements
Determining the Cause
Determining the Action to Take
Implementing the Action
Potential Adverse Effects
Lecture 6 – Auditing CA&PA
DAY 02(8:30 AM - 4:30 PM)
Lecture 7 – Quality Tools
Cause and effect diagrams
5 Why Analysis
Is/Is Not Analysis
Lecture 8 – Statistical Tools
Time series analysis
Statistical Process Control
Process Capability 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