CAPA Considerations: A Comprehensive Overview

Utilizing proven methodologies, this highly interactive course provides learners with the tools and skills needed to identify root causes of existing nonconformities from complaints, process deviations, audits, and other feedback mechanisms.

This two-day instructor-led training covers how to effectively write concise, understandable problem statements and specific corrective action plans relative to those statements. Learners are provided with instruction and guidance on the utilization of root cause analysis techniques, working through case studies, and summarizing key findings. Our highly experienced instructor will provide real-time feedback to help learners develop the skills necessary for effective corrective action remediation.

By the end of this training learners will be able to:

• Define the purpose of Corrective and Preventive Action (CAPA)
• Identify and analyze data inputs for CAPA
• Compose a proper and complete problem statement
• Examine different root cause analysis tools and identify when to use them
• Apply investigation techniques to identify root causes and define the appropriate corrective action
• Identify effectiveness criteria and perform an effectiveness check
• Recognize how to close the CAPA loop in a timely and complete manner.

Professionals at all levels of the organization will benefit from this learning including those involved in the receipt, evaluation, and involvement in the conduct, review and documentation of root cause investigations and improvements.

Course tutors selected from the following:

Janet Book - Janet Book has worked in the field of quality for over 35 years in various industries, including blood banking, food processing, quality consulting, chemicals, pharmaceuticals, and medical devices, with both large and small companies. She has conducted internal and supplier audits using many different industry-specific standards and regulations. She also has vast experience writing quality procedures, developing quality management systems, and developing and presenting quality-related training and seminars. Ms. Book is a senior member of the American Society for Quality (ASQ), an ASQ Certified Quality Auditor (CQA), an ASQ Certified Quality Engineer (CQE), an ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) and a RABQSA Quality Systems Lead Auditor.

James Pink - James Pink has over 20 years of experience in the medical devices industry, including 10 years as a health care technology expert and lead auditor for a prominent European notified body. He began his career as a product designer in the oil tools industry before moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, England. His industry experience includes managing product development and quality assurance programs for active and nonactive implantable and combination products. Mr. Pink is a contributor to several medical device standards committees, including ISO 13485, ISO 14971 and various product-related standards.