FDA Medical Device Inspections: What to Expect

Recognizing what to expect during an FDA inspection enables a medical device manufacturer to effectively prepare for the inspection. This instructor-led two-day course is designed to prepare domestic and foreign medical device manufacturers doing business or intending to do business in the United States to recognize and prepare for FDA pre- and post-market inspections.

This course focuses on identifying FDA inspection criteria, resources (including key standard operating procedures such as CP 7382.845) and practices used to plan, conduct, and assess inspections of medical device manufacturers.

On completion of this FDA medical device inspections course, you will be able to:

• Identify key requirements of the FDA’s Quality System (21 CFR Part 820) and Medical Device Reporting (21 CFR Part 803) Regulations
• Recognize the intent of regulatory requirements as described in preamble discussions
• Recognize key similarities and differences between 21 CFR Part 820 and ISO 13486:2016
• Identify inspectional resources used by FDA investigators
• Identify key elements/focus of FDA’s Quality System Inspection Technique (QSIT)

This course benefits quality professionals responsible for managing, facilitating, and participating in FDA inspections, as well as those responsible for defining, documenting, implementing, and maintaining an effective quality management system.

This course is important for medical device professionals, especially those who conduct or participate in any project and/or quality management system activity.

Course tutors selected from the following:

Robert Ruff - Rob 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 FDA’s computer-based training for QSIT, the Quality System Regulation and the Medical Device Reporting Regulation.

Nanci Dexter - Nanci has over 35 years of experience in the medical device and IVD industries. Nanci has created numerous quality systems for small and medium-sized companies, conducted mock FDA and ISO13485 audits and authored many worldwide regulatory submissions. Her diverse experience ranges from auditing, leading compliance remediation projects, conducting regulatory strategies and holding regulatory and quality management positions in both the United States and Europe.

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.

Christine Brown - Christine has over 30 years of experience working with regulated medical device, combination products, and pharmaceutical manufacturers and FDA class I, II and class III devices. Her areas of expertise include Post Market Quality, CAPA), Quality Systems, Quality Management, Product Development, Production and Process Control, and External Agency Inspections (FDA-483, warning letter, and consent decree situations). She has been an expert witness and participant in the FDA 510(k) premarket applications under the FDA Accredited Person Program for medical devices, as a third party-reviewer. Christine holds a Bachelor of Science in Biomedical Engineering And holds certifications as a Certified Software Quality Engineer, Certified Reliability Engineer, and Certified Quality Auditor from the American Society for Quality in addition to being a certified Quality Systems Auditor for ISO13485:2016 and MDSAP.