The Online Medical Device Single Audit Programme With SQT Training
By Gemma Creagh - Last update
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The Medical Device Single Audit Programme (MDSAP) is the single biggest step towards global harmonisation of medical device regulation seen to date. This SQT Training course details the main requirements of the regulations from Brazil, Australia, Canada and Japan and shows how these relate to ISO 13485, the EU MDR and the US Quality System Regulation (QSR). The course also deals with the MDSAP audit process and how to prepare for the MDSAP audit. In fact, all manufacturers who sell Medical Devices (class 2 or higher) into Canada from 1st January 2019 onwards must have their Quality Management Systems approved under the MDSAP programme.
Duration: 2 training days
Delivery Mode: This programme is available In-House and via Virtual Training
Course Start Date: 17th June 2020
Fee: €795
Online Medical Device Single Audit Programme: What’s covered?
Day 1
Introduction to MDSAP
Auditing Organizations (AOs) authorised to conduct MDSAP audits
MDSAP Audit Process: o How to apply for MDSAP o The Three- Step Audit Approval System o Introduction to the Audit Companion Document o The New Non-conformance Rating System o Audit Approval and Re-certification Timelines
Advantages and Disadvantages of adopting the MDSAP approach
Overview of the Requirements for Medical Device Registration and Labelling in Brazil, Australia, Canada and Japan and how these compare to with EU and US medical device regulations: o Specific requirements of the Brazilian ANVISA Regulation of Medical Products RDC 185/2001 where these differ from US and European Requirements o Specific requirements of the Australian Therapeutic Goods (Medical Devices) Regulations SR 2002 No. 236 where these differ from US and European Requirements o Specific requirements of the Canadian Medical Devices Regulation (CMDR) SOR/98/28, where these differ from US and European Requirements. o Specific requirements of the Japanese PMD Act 2014 (formerly JPAL) where these differ from US and European Requirements
Day 2
The similarities and differences between the requirements for Quality Management System Requirements in the various regions: o Brazil; ANVISA RDC 16/2013 GMP for Medical Devices and IVDs o Australia; Therapeutic Goods (Medical Devices) Regulations SR 2002 No. 236 o Canada; Canadian Medical Devices Regulation SOR/98/28 o Japan; PMD Act 2014
How the above relate to ISO 13485 and the US QSR 21 CFR Part 820
Participation in Mock Audit Scenarios against the Requirements of MDSAP Participant Countries
How to Prepare for the MDSAP audit
Delegates must attend both days to receive a Certificate of Attendance
Who should participate?
Quality Managers and Quality Engineers
Staff with responsibility for designing and implementing Quality Systems
Internal Auditors
Personnel responsible for supplier / external audits
Departmental Managers and supervisory staff
What will I learn?
Participants achieve the following learning outcomes from the programme;
State the key points of the MDSAP approach
Identify key differences between the regulations from the various jurisdictions involved in MDSAP
Identify the key Quality Systems requirements necessary for success in the MDSAP audit
Determine the steps necessary to prepare for the MDSAP audit
Determine key elements to include in an audit programme designed to maintain compliance with the regulations of MDSAP countries
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