Qualys Innova
Qualys Innova is an expert of FDA focusing to medical device & IVD.
Over not only the prepare project for accommodating to the FDA
inspections based on extensive experience, FDA-GMP (QSR) compliance,
but FDA seminar preaching the medical device development principle in
unique approach and changing awareness of participants, contracting of
the multi support internal audit for QSR, ISO and the Pharmaceutical
Affairs Law ( Japan ), contracting of supplier audit, and contracting
of the OEM product development contracts that was in the market in
Japan, the high quality measure of Qualys Innova own accelerates your
innovation.
With experience of auditting the plant in the world as FDA support
corporate audit staff of GE healthcare with 100 or more factories and
performance of supporting many improvement projects as GE six sigma
Black Bert, the seminar for FDA preparation which changes mind of the
employee completely not only observing FDA regulatory requirement but
focusing on the product quality which is the essence of the
regulation, and GAP audit are very popular.
Qualys Innova deals with many on-site seminars, the FDA inspection
preparation project, and OEM product development, and popularity has
been acquired.
Contact Us
Qualys Innova
5-5, 7 Seishin, Sagamihara-shi, Kanagawa, Japan
Mail : mail@qualysinnova.com
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FDA GMP ( QSR ), Design Control Guidance, CAPA, P&PC Process Validation, Software Validation, On-Site Training.
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The prepare project for accommodating to the FDA inspections.
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OEM development of Medical Device in Japanese market. / Application to MHLW and testing for application.
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Establishment of FDA GMP ( QSR )
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Outsource of Internal Audit and Supplier Audit. / Any improvement projects based on Six Sigma method.