Preparing for FDA Medical Device Inspections – Practical Guidance (Advanced)

Understanding what to expect during an FDA inspection enables a medical device manufacturer to prepare effectively for an FDA inspection. This course is designed to meet the needs of domestic and foreign medical device manufacturers doing business or intending to do business in the United States. This course focuses on group activities designed to identify the key elements of Level 1, 2, 3 and For Cause inspections; preparing for and hosting an FDA inspection; review FDA databases (MAUDE and Recall) to identify and understand the focus of an FDA For Cause inspection; review the preamble and QSIT Guide to understand how to prepare for an inspection of the primary subsystems contained in QSIT; develop effective FDA 483 responses; and prepare in advance information needed by the investigator to complete an EIR (as described in the IOM). This course is designed to benefit your organization’s quality professionals responsible for preparing for, facilitating, and responding to FDA inspections; as well as those responsible for defining, documenting, implementing, and maintaining an effective quality management system.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

• Identify key elements of FDA’s Quality System Inspection Technique
• Recognize the types of FDA inspections
• Recognize key activities and responsibilities relative to hosting an FDA inspection
• Identify pre-inspectional databases (e.g. MAUDE, Recall) used by FDA Investigators in preparation for FDA inspections and their utility
• Identify key elements of an effective FDA 483 response
• Prepare (in advance) key documents and information required to be included in an FDA Establishment Inspection Report (EIR)

Who should attend
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.

Price: $1200.00