This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program. The introduction will give an overview about the requirements for the quality management system and how to conduct an internal audit with MDSAP requirements to check, if your quality management system meet all MDSAP requirements.
You should attend this webinar to understand, what how is MDSAP working in relation to your internal audit program and how to adjust your internal audit program and finally how to conduct an internal audit according MDSAP requirements.
This webinar will give you a clear structured overview and introduction, how to apply MDSAP-Requirements in your internal audit program and to conduct internal audits with MDSAP requirements. First you learn to identify the relevant requirements, second you learn how to implement the identified requirements into your audit program. The course based on the MDSAP Companion-Document, issued by the FDA.Areas Covered in the Webinar:
Medical Device Manufacturer, who develop, manufact and / or sell to US, CAN, BR, AUS, JP
Senior Expert Medical Devices, Frank Stein healthcare projects
Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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