CAPA Considerations: Problem Statement Writing and Investigation Techniques

Currently there are no upcoming CAPA Considerations: Problem Statement Writing and Investigation Techniques courses scheduled. Contact us to find out when the next course will run or if you need customized training. We can deliver this course and a broad range of other training topics at your location, off-site or virtually.

Contact us

About This Course

This highly interactive medical device CAPA writing course provides students with the tools and skills needed to identify root causes of existing nonconformities from complaints, process deviations, audits and other feedback mechanisms, utilizing proven methodologies.

You will learn how to effectively write concise, understandable problem statements and specific corrective action plans relative to the problem statements. Students will be provided with instruction and guidance as they conduct hands-on medical device writing exercises, working through case studies of investigation data and summarizing the key findings. A highly experienced instructor will provide real-time feedback to help you write concise medical device nonconformity statements.

Key Learning Objectives

By the end of this course on CAPA writing for medical devices, you will be able to:

  • Recognize the purpose of a corrective and preventive action
  • Identify and analyze data inputs for CAPA
  • Compose a confident, proper and complete problem statement
  • Examine and practice utilizing root cause analysis and problem-solving tools
  • Apply root cause analysis, problem-solving and failure investigation techniques to the identification of root causes
  • Define appropriate corrective actions
  • Identify effectiveness criteria and perform effectiveness checks
  • Recognize the requirements to correctly close the CAPA loop in a timely manner

Who Should Attend

This CAPA considerations course — including problem statement writing and investigation techniques — is important for medical device professionals, from those involved in the receipt and evaluation of complaints and other feedback to quality managers, internal auditors and particularly those involved in the conduct, review and documentation of root cause investigations and improvements. Medical device professionals at all levels of the organization will benefit from this learning.

Course Tutors

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.

Robert Ruff - Robert Ruff has over 30 years’ experience in the medical device and public health sectors, including completing a long, distinguished career with the U.S. FDA. His extensive regulatory experience includes co-authoring the MDSAP Audit Model and the Quality System Inspection Technique (QSIT). He also developed the FDA’s computer-based training for QSIT, the Quality System Regulation and the Medical Device Reporting Regulation.

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.

Cathy Arroyo