The FDA will only approve devices that are designed so that it is practically impossible for people to accidentally harm themselves even if they use the device improperly.
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.
Session 1: Quality System Inspection Techniques (QSIT)
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.
Session 2: Inspection Strategies, Instructions, and Analytics
Length: 75 minutes
In this session, Angela will provide you with a high-level description of the regulations that are addressed, and will discuss the inspector’s objectives in assessing compliance as well as the instruction they would receive from the FDA to go ahead with the inspection. The session will then delve into details as to how the subsystem building blocks from the previous session are used to conduct the inspections. Further, Angela will discuss which parts and how to use the subsystems and what to report.
Session 3: Administrative Follow-Ups
Length: 45 minutes
When things go wrong during an inspection, the FDA conducts administrative follow up both in terms of alerting the device manufacturer, and ensuring that the manufacturer resolves the issue. In this session, Angela will discuss how FDA determines who should be held accountable for the issue, how violations for each subsystem are handled, how to handle violative devices and what administrative and/or legal actions need to be taken. The session will also include a discussion on recidivist violators.
Exclusive Q&A session following the live event to get advice unique to your situation.
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