Successfully Handling FDA Inspections and ISO Audits for Medical Devices

This course will begin with an overview of how FDA inspections and ISO Audits have evolved and will include how the FDA prepares prior to conducting an inspection.  Discussion will include a thorough review of all relevant regulations including 21 CFR, Part 820 and ISO 13485.  Additionally, the course will detail how to prepare for an inspection and the logistics involved in assigning roles and responsibilities to inspection team members.

The course will provide a step-by-step guideline for how the inspection will occur starting with the arrival of the inspector or auditor.  These guidelines will include how to communicate with the regulator, as well as, interacting with the inspector or auditor during the process.  The course concludes with a detailed discussion, including a Case Study, on how to handle post inspection deliverables and responsibilities.