Writing Effective Nonconformity Statements During Medical Device QMS Audits

This instructor-led one-day course will introduce you to the importance of writing effective nonconformity statements during medical device manufacturer quality management systems audits

This course covers the fundamentals of medical device QMS auditing that influence the writing of effective nonconformity statements; and how to recognize when to communicate nonconformities during an audit; and identify tools and tips for writing effective nonconformity statements.

In addition, learners will apply the concepts covered during the course through practical application. Working in groups, learners will review multiple nonconformity scenarios, develop nonconformity statements relative to the scenarios and participate in instructor-led analysis of the nonconformity statements.

At the end of this training, learners will be able to:

• Identify useful techniques to apply when writing effective nonconformity statements
• Review fundamental terminology important to writing effective nonconformity statements including audit, objective evidence, audit criteria, and nonconformity
• Evaluate the use of the acronym FOCAL as a tool for developing an effective nonconformity statement.
• Apply the three key principles when writing a nonconformity statement

This course is vital for anyone who conducts or manages internal, supplier or third-party audits within the medical device manufacturing space. The tools and tips shared in this training will help ensure that the auditee organization clearly understands the nonconformities, so that they can identify and implement effective investigations and subsequent containment, correction, corrective action, and systemic corrective actions, as appropriate.

Course tutors selected from the following:

Robert Ruff - Robert Ruff has over 35 years of experience in the medical device and public health sectors, including working in orthopedic implant manufacturing and completing a long, distinguished career with the U.S. FDA. His extensive regulatory experience includes leading the development of the Medical Device Single Audit Program as well as co-authoring the MDSAP Audit Approach and the Quality System Inspection Technique (QSIT). Since 2017, Rob has conducted audits relative to a variety of criteria for NSF. He is also responsible for NSF training on medical device manufacturing topics. In this role, Rob has developed courses on a range of subjects, including auditing against the EU MDR and EU IVDR, risk management, FDA inspection readiness, design controls, and more.

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 leading European notified body. He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assurance programs for active and non-active 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.

Janet Book - Janet Book has worked in the field of quality for the past 35 years in a wide variety of industries, including blood banking, food processing, quality consulting, chemical, pharmaceuticals and medical devices, she has conducted internal and supplier audits utilizing many different industry-specific standards, due diligence evaluations as well as capability assessments. She has been involved with writing quality procedures; developing supplier, internal and corporate audit programs; developing quality management systems; and developing and presenting quality-related training and seminars. Janet is a certified Six Sigma Black Belt and served as an adjunct professor at Carnegie Mellon University. Recently, she earned her Certificate in Privacy Law and Cyber Security and worked in privacy providing guidance on quality, regulatory and compliance functions. She 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 an RABQSA Quality Systems Lead Auditor.

Deborah Baker-Janis - Deborah joined NSF after working in the medical device industry for over 10 years, in both regulatory affairs and product development. Her experience includes domestic and international regulatory strategies and submissions, design control documentation development, quality management system and regulatory affairs procedure development and remediation, and training development and execution. Deborah has supported the development and commercialization of a wide range of products including cardiovascular devices, general and plastic surgery devices, gastroenterology devices and general hospital devices. Her educational background is in biomedical engineering.

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.

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.