Preparing for FDA Medical Device Inspections – The Requirements

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 13485:2016
• 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:

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.

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.