Technical Medical Device
Take all the three and earn your certificate or choose from individual courses
This certificate is geared toward students who have completed the Essential Medical Device Certificate or have at least one year of industry experience.
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- Fundamentals of Internal/ISO and FDA Audit Preparation
This course is both an introduction and a good refresher for all personnel involved in the FDA inspection and ISO certification processes and an opportunity to compare your internal audit system against what might be expected for compliance. Included is a summary of the types of the FDA inspections and the different outcomes, along with some tools and knowledge needed to assure that your quality system conforms to the QSR.
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Essentials of Risk Management
This course provides participants insight and awareness of how to implement a Risk Management system and use it throughout the product lifecycle and in support of the Quality Management System. The key components of an effective risk management process, how to perform a risk analysis using both hardware and software examples. How to apply the risk analysis techniques to validation activities and the CAPA process. Also included is a review of the relationship between FDA and ISO regulations and adequate risk management.
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Process and Equipment Validation for the Medical Device Industry
This intensive course covers the key aspects of an absolutely essential part of medical device manufacturing...the validation of processess and equipment. Understanding of the key terms and steps in process validation and verification, including qualification steps (IQ, PQ, OQ, etc.) protocol definitions, GHTF guidelines, and selected tools and techniques are all covered in this course.
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