The CAPA subsystem is the backbone of a management system to maintain compliance, effectiveness and efficiency. Failing to meet requirements of effective CAPA handling, especially investigations of root causes, and verification of effectiveness are among the most frequent serious audit and inspection findings. This course is intended to familiarize participants with the requirements for a CAPA subsystem and the methods for effective CAPA implementation.
 
Course objective and outcome

• The regulatory requirements behind CAPA procedures will be understood
• Being familiar with the wording used around CAPA
• Participants will be enabled to explain logical links within a Quality System (21CFR820 / ISO 13485) related to CAPA
  • Post Market Surveillance
  • Risk Management
  • Vigilance
  • Design Change Control
• Knowing the data sources for input in CAPA
• Participants will get acquainted with CAPA process sequences
• Applying root cause investigation techniques
• Participants will be able to determine effective corrective action related to root causes identified including prospective determination of methods and timelines to check CAPA effectiveness

 Content

• Requirements from 21CFR820 and ISO 13485 for Corrective and Preventive Action
• Definitions & Terminology – speaking the same language is key in the context of CAPA
• Data sources for CAPA – internal / external
• Logical sequences to be followed and documented
• Determining root causes, tools and methods
• Planning of activity and required competence within a Corrective Action including check of effectiveness
• Case study of a CAPA case for exercising the sequence and root cause analysis
• Discussion of case study results

Who should attend
Management staff
Engineers working in development
QA Managers
QA Staff
 
Trainer
Somashekara Koushik Ayalasomayajula, Senior Associate, Medidee Services SA
 

"Very knowledgeable instructor and excellent course materials"

"Good instructor"

Participants, Spring 2020