How to prepare for an FDA quality system inspection
Full set of 10 CDs—$995.00—saves 31% over the individual price
(Available as download only, link will be sent by email)
This is the only training of its kind that shows the U.S. Food and Drug Administration's (FDA) top trainer teaching new FDA inspectors how to inspect medical device manufacturers against the FDA's Quality System Regulation (QSR) 21 CFR Part 820. An FDA produced and sanctioned training series.
"I've paid $2000 to attend FDA workshops that couldn't come close to providing this depth and breadth of coverage on the Quality System Regulation. When I first saw the FDA's top trainer, training actual FDA inspectors from inside their building, I knew this was a one-of-a-kind series. It just blows my mind to witness FDA investigators having a dialogue with the trainer over ambiguities we all struggle with, and then have the trainer clarify to those investigators the proper application of the regulation. There isn't anything other resource like this. We constantly reuse the videos for training our employees."
Grant Ramaley, Director of Regulatory Affairs, Aseptico Inc., Woodinville, WA
A failed FDA inspection can damage the public image of a company with embarrassing Warning Letters that are posted for 10 years on the FDA website.
The Quality System Inspection Technique (QSIT) remains unchanged since 1999 to the present (2015). These videos were started in 2005 and represent interpretations of the QSIT inspection, styled and taught by one of the most experienced FDA investigators ever employed at the US FDA Office of Compliance. Although four minor changes were introduced in September 2013 related to "Unique Device Identification" (a separate regulation under 21 CFR Part 830). QSIT continues to focus on the Quality System Regulation processes of 21 CFR Part 820.
Windows XP (Service Pack 3), Windows 7, Windows 8, Windows 10
Internet Explorer 6 or later (this training program runs within a browser, even though is on a CD)
Note: This program will not run in Chrome, Firefox, or Safari. It will not run on a Mac.
Note: This video preview is lower resolution than what you will get with the purchased set of disks.
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Every medical device manufacturer that is required to meet the FDA Quality System Regulation will find these disks valuable and unequaled.
Different disks can cover different audience groups. For example, the disks related to "Design Controls and Process Validation" are more relevant to engineers.
Sales staff, repair department personnel, and customer service representatives will benefit from the disk related to identifying and handling "Complaints."
All quality managers and related regulatory professionals responsible for FDA compliance will find this training to be extremely valuable.
Knowing how the FDA interprets its own Quality System Regulation is important in ensuring that a company develops its quality system to meet these unique FDA legal requirements. Imagine having in hand the video record of the FDA's own words about how your quality system is supposed to function and then to be able to replay and reuse it for internal training, or even use it for dispute resolution with the FDA!As new employees come and go, the ability to replay the videos, and to emphasize the perspectives of these law enforcement officers, is training that increases in value, every time it's viewed.
See the table below, and click on each session for its outline. Each disk explains one or more parts of the FDA Quality System. The set begins with a historical overview of the FDA's Quality System Regulation, how it came to be, and its relationship with ISO 9001 and ISO 13485. The remaining disks cover all of the major sub-sections of the QSR.
This training has the added advantage for ESL (English as a Second Language) viewers, as every word spoken by the instructor is displayed right below the video.