Corrective and Preventive Action Requirements and Industry Practice
This 2 day course provides intensive coverage of the elements of a corrective and preventive action (CAPA) system.
Overall Objective
Upon completion of this course participants will be able to evaluate their organization’s compliance with FDA’s requirements for establishing a Corrective and Preventive Action system. Further, they will be able to implement a compliant business value-added CAPA system to effectively manage existing and potential product and quality system nonconformities.
Specific Objectives
Participants will obtain an understanding of:
- Purpose of a CAPA system
- 21 CFR 820 Quality System Regulation and ISO 13485 CAPA requirements
- GHTF final CAPA document recommendations and how they align with regulatory requirements
- Differences between corrections, corrective actions, preventive actions and ‘continuous improvement’
- How a CAPA system is integrated throughout a Quality Management System (QMS)
- Appropriate data sources, how to analyze, and how to manage (escalation)
- How risk management is used in conjunction with the CAPA system
- How to coordinate and analyze data across various data sources, with an emphasis on potential issues
- Various investigation tools to identify root cause(s) and actions
- Various methods for verifying and/or validating actions and the difference between verification and validation of identified actions
- CAPA plans; how to write good CAPA plans, including resources and timing of actions; and how to effectively implement CAPA plans
- How to make decisions on the extent of actions, i.e. when field actions are warranted
- Effectiveness checks and various methods to achieve effectiveness checks
- FDA’s perspective on CAPA systems and compliance expectations
Who Should Attend?
Instruction is targeted to quality assurance, quality system compliance and regulatory affairs professionals; personnel responsible for the implementation of CAPA systems; and CAPA system management.
General Outline
- Day One AM: Introduction; Regulatory Requirements; Planning for the CAPA System
- Day One PM: Measurement and Analysis; Improvement - Investigations
- Day Two AM: Improvement - Implementation/CAPA Plan
- Day Two PM: Management Reporting; FDA Perspective and Complaince
This outline closely follows that of the GHTF Final Document Quality management system – Medical Devices – Guidance on corrective action and preventive action and related QMS processes, published November 4, 2010.
Dates and Hotels
| DATE | LOCATION | PHONE & RATES |
| May 6-7, 2013 |
The Westin Alexandria 400 Courthouse Square Alexandria, VA 22314 Website |
866-837-4210 $209 single/double Reservation ID: AAMI Rate through 4/7/2013 |
Faculty
Course faculty are drawn from an experienced group of quality systems professionals. All course faculty have completed an instructor training program to ensure consistency and quality from session to session. The mix of industry leaders, consultants, and FDA personnel helps to ensure a balanced presentation of the requirements and paths to compliance.
Fee and Registration
Fee includes PowerPoint presentations and case studies; relevant standards and technical information reports; pertinent FDA documents and additional references; and continental breakfast, lunch, and refreshments. Click here to go to registration.
| REGISTRATION TYPE | FEES |
| AAMI corporate and institutional members | $1735 |
| AAMI individual members | $1835 |
| Nonmembers | $2135 |
| Government employees | $635 |
| OPTIONAL ONLINE POST-TEST | FEES |
| AAMI members and government employees | $50 |
| Nonmembers | $75 |