CAPA Considerations: Problem Statement Writing and Investigation Techniques

Utilizing proven methodologies, this highly interactive medical device CAPA writing 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 course covers how to effectively write concise, understandable problem statements and specific corrective action plans relative to problem statements. Learners are provided with instruction and guidance as they conduct hands-on medical device writing exercises, working through case studies of investigation data, and summarizing key findings. Our highly experienced instructor will provide real-time feedback to help learners write concise medical device nonconformity statements.

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
• 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 and the requirements to close CAPAs in a timely and complete manner.

This course 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 selected from the following:

Janet Book - anet 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 – Cathy has more than 30 years of direct experience in medical device regulatory compliance within the engineering, manufacturing, servicing, supplier, quality, complaint, recall, and audit management fields with both large and small companies. She is an experienced facilitator of FDA inspections, has contributed to the development of responses at all levels of regulatory enforcements actions, and has participated in numerous FDA/Corporate meetings, directly and as a consultant. Cathy has served as a lead auditor for internal audits, external audits, and mock FDA inspections. She has provided training in forensic failure analysis, investigation techniques, CAPA, complaint handling, recall management, and auditing. Cathy has also served as an expert witness.

Gert Sorensen - Gert Sorensen has worked in the field of Medical Device quality for the past 22 years in different roles; as a QA specialist within global companies producing class I, II and III Devices also including electronics and software. Gert has also worked as a consultant specialized in FDA 21 CFR compliance, Process Validation and Software Validation and as Notified Body Auditor.

Gert has conducted internal audits, supplier audits and third-party audits under ISO 9001 and 13485, MDD 93/42/EEC, MDR 2017/745 and MDSAP. He has also conducted due diligence evaluations as well as capability assessments. He has been involved with writing quality procedures; developing supplier, internal and corporate audit programs; developing global quality management systems; and developing and presenting quality-related training and seminars.

Ashley Kelleher - Ashley has more than 14 years of professional experience in the medical device, pharmaceutical and certification industries. Her experience includes program management and project management of global, third-party, and notified body certifications for the medical industry. In addition, Ashley has expertise in reviewing technical file documentation (CE marking) and holds lead auditor certifications for ISO 13485, GDP, MDSAP, EU-MDR, ISO 14971, ISO 9001, and ISO 15378. Her educational background is in veterinary science.