FDA Inspection - Online Live Training (Hebrew)

An FDA inspection is a careful, critical, official onsite examination of a facility to determine its compliance with federal law. ​

Medical device manufacturers who intend to commercially distribute their products in the United States must be prepared for FDA inspections. They should know how to prepare for an inspection and how to manage the inspection process.​

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Training content:​

• What is FDA?​
• FDA Product classification​
• FDA enforcement actions​
• FDA Inspection – how to prepare? Before, during and after the inspection.​
• FDA Quality System Inspection Technique (QSIT)​
• 483’s and Warning Letters – trends and examples​

The training includes examples from the industry of how companies have prepared for FDA inspections.

Duration: 2 hours

Audience: All medical device employees - Quality, Design, Manufacturing Associates, Engineers and Managers

About the lecturer: Helit Dovrin, Executive Consultant, Auditor, Lecturer and Coacher worked for more than 25 years as Quality and Regulatory Senior Leader at the world leading medical device companies such as: Philips Healthcare, GE Healthcare, Align Technology and Biosense Webster part of Johnson & Johnson. She gained experience & expertise in all areas of the Quality Management System and Regulatory Affairs including FDA & Notified Body Inspection Management, ISO-13485, EUMDR & MDSAP Compliance Audits, and Quality & Safety escalations.