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M11 - Medical Device Auditing Professional - How to Audit Series - Medical Devices - Combination Products

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Part of Medical Devices Training Module 11

Dates: Thursday 12 November 2025
Venue:
Manchester - Venue to be confirmed
Cost:

£735.00 excl VAT

Type: Medical Devices
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About this course

This course is particularly biased towards medical device manufacturers that now face the likelihood of a GMP (pharma) based inspection or audit. The course is aimed to address the cross over between medical device and medicinal product regulations and enables traditional medical device auditors to understand the specific requirements for the active ingredient or specialist material that may be subjected to non-medical device regulation. From controls of raw materials, environmental and GMP expectations to the release of a combination product this course will certainly enable you to undertake audits in a way you would not have covered as a general medical device auditor.

Who Should Attend

Any professional with the responsibility for internal, supplier or third party audits where understanding the best practices for medical device auditing is crucial. This module establishes you as a thoroughly trained auditor in the field of medical device regulatory compliance. Pharmaceutical quality professionals now responsible for medical device organizations will benefit greatly from this course.

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Bev Willett, Course Administrator, NSF Heath Sciences

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