Corrective And Preventive Actions (CAPA) - Online Live Training (Hebrew)

Corrective and Preventive Actions (CAPA) are the heart of any quality management system (QMS). CAPAs are used to identify and address the root causes of problems, and to prevent them from recurring.

By implementing effective CAPA processes, organizations can improve their products and processes, and ultimately, their bottom line.

Training content:

• The purpose of CAPA
• Inputs to the CAPA process
• The steps involved in implementing a CAPA
• The tools and techniques used for root cause analysis
• Risk Assessment
• The importance of monitoring and evaluating CAPAs

The training includes examples from the industry of how companies have implemented successful CAPA programs.

Intended for: All employees involved in the CAPA process.

Training Agenda:

09:30 – 10:00 Introduction to CAPA: Overview and Regulatory Requirements

10:00 – 11:30 Requirements of the following CAPA elements:

• Problem Description (including Risk Assessment)
• Containment Action/s
• Investigation and Root Cause Analysis Tools

11:30 - 11:45 Break

11:45 – 12:30 Requirements of the following CAPA elements:

• Corrective Actions and Preventive Actions
• Effectiveness Verification

Monitoring and escalations of CAPA's

12:30-13:00 Q&A

About the trainer:

Helit Dovrin - Executive Consultant, Auditor, Lecturer and Coacher worked for more than 25 years as Quality and Regulatory Senior Leader at the world leading medical device companies such as: Philips Healthcare, GE Healthcare, Align Technology and Biosense Webster part of Johnson & Johnson.

Helit gained experience & expertise in all areas of the Quality Management System and Regulatory Affairs including FDA & Notified Body Inspection Management, ISO-13485, EUMDR & MDSAP Compliance Audits, and Quality & Safety escalations.