The FDA’s Compliance Program Guidance Manual for the inspection of medical devices states that the FDA field inspectors conduct administrative and enforcement activities related to the Quality System (QS) Regulation (21 CFR 820), the Medical Device Reporting (MDR) Regulation (21 CFR 803), the Medical Device Tracking Regulation (21 CFR 821), the Corrections & Removals Regulation (21 CFR 806), and the Registration & Listing Regulation (21 CFR 807).
Under the QS regulation, manufacturers are expected to control their devices from the design stage through post market surveillance. Manufacturing processes, such as sterilization, are required to be implemented under appropriate controls. However, the MDR, Tracking, and Corrections and Removals regulations involve activities with which manufacturers and importers are required to comply after the devices are distributed.
Before inspectors can conduct the above inspections, they are trained by the FDA on how to conduct inspections. This training program encompasses the five regulations for inspecting medical device firms.
Why You Should Attend
Join this virtual boot camp, where food safety expert Angela Bazigos will examine the training that FDA inspectors receive on five regulations for inspecting medical device firms. Angela will present the specific guidance FDA inspectors receive for each of the regulations.
As a result, you will understand not only what you need to do to set up your company for a successful inspection, but also why you need to do it. You will get insight into the workings of the inspectors’ mind to understand what they are looking for during an inspection.
Length: 60 Minutes
Join this session for information about the Quality System Inspection Technique (QSIT) used by the FDA, and the associated major and minor subsystems. In this session, Angela will discuss how inspection of the subsystems forms the building blocks for each inspection. Angela will also discuss inspection objectives and inspection process for each subsystem.
This session will discuss the components of QSIT, which include:
Length: 75 Minutes
This session will discuss aspects of FDA field reporting requirements, which include:
Length: 45 Minutes
This session will discuss the aspects of FDA field reporting requirements, which include:
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / client... Read More