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Marie Dorat

Marie Dorat, CQA, CAA is a QA/RA compliance, GxP Training and International product registration Consultant with 17 years experience in the Pharmaceutical/Medical Device & IVD Industry She also is the CEO of IPRF, LLC which specializes in helping established and start-up companies, develop compliant Quality Systems; GCP, Supplier Qualification, Audit, CAPA, and Master Validation Programs. MS. Dorat has worked with Implantables, Wearables, Vaccines, IVDs, Medical Devices with software as well as Software as a Medical Device and mobile application devices. She has also published articles on various GxP subjects

 Webinar Id: LSHCMDF001
 6 months unlimited
 Duration 75 mins
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FDA/EU MDSAP Inspections - Getting Prepared

Inspections are critical to the success of the business on several levels. Therefore, being appropriately prepared and management of the inspection process is a critical activity. The consequences if a company does not pass an inspection are time consuming, delayed product approvals, and could lead to civil or even criminal litigation by the FDA and EU inspection agencies.

$167 Recorded (6 months unlimited access)

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