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SUMMARY:MPD Training Course: Medical Device Audit Fundamentals
DESCRIPTION:This one-day course is designed for those who need to better understand what medical device audit is\, what it is trying to do\, how to do it\, and when it is required. \nYou might be new to medical devices\, about to get involved with internal audit\, perhaps you are thinking of becoming an auditor? Perhaps you are a senior manager who wants to know the fundamentals to help you manage your team? \nIn just one day\, the course will cover: \n– Role of the key players in Europe: Competent Authorities and Notified Bodies.\n– Where to find key guidance so you can answer the exam question!\n– Standards you can learn from.\n– What is the ‘Blue Guide’ and why it is so important.\n– Notified Body Unannounced Audits and the effect on the supply chain.\n– Differences between Competent Authority and Notified Body Audits.\n– MDR/IVDR and ISO 13485: 2016 and effect on audits.\n– Insights about United States (US) Food and Drug Administration (FDA) Inspections.\n– Comments on the Medical Device Single Audit Program (MDSAP) and why this matters so much to those who want to market to Canada!\n– The Direction of Travel!\n– What is CE marking and why the ‘Blue Guide’ matters.\n– Auditing – the process for effective results. \nTo view the programme and further information (including target audience\, learning outcomes and speaker profile) click on the Event Brochure link below. \nMember cost: £ 200\nNon-Member cost: £ 300 \nAll prices are excluding VAT \nOnce we receive your booking form\, you will be sent a confirmation email and an invoice. \nEvent Brochure\nDelegate List \n \n  \n 
URL:https://staging.medilinkmidlands.com/event/mpd-training-course-medical-device-audit-fundamentals/
LOCATION:MeetPoint Midlands\, Conference Centre\, 28 High Street\, Kegworth\, Derbyshire\, DE74 2DA
CATEGORIES:Medilink Midlands Event
ORGANIZER;CN="Becky Sharpe":MAILTO:events@medilinkmidlands.com
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