MDSAP Internal Quality Auditor

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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 course details the main requirements of the regulations from Brazil, Australia, Canada and Jap... Read More

The Medical Device Single Audit Programme (MDSAP) is the single biggest step towards global harmonisation of medical device regulation seen to date.  This course details the main requirements of the regulations from Brazil, Australia, Canada and Japan and shows how these relate to ISO 13485: 2016 and the US QSR and how to audit against them.

All manufacturers who sell Medical Devices (class 2 or higher) into Canada from 1st January 2019 onwards must have their Quality Management Systems (QMS) approved under the MDSAP programme. In order to meet this deadline, manufacturers will have to apply for MDSAP and successfully complete the audit programme in 2018. The Auditing Organizations that approve Medical Device manufacturers under MDSAP will expect to see evidence that the QMS has been audited, by trained auditors, against the MDSAP requirements.

This two day course provides detailed training in developing the skills necessary to be an effective MDSAP internal auditor.

 

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What's covered?

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Please Note: A practical audit within the company forms the basis of Day 2. Audit areas within the company must be organised prior to the training so that effective preparation can commence on Day 1.  For this reason the numbers on this course are restricted to max 12 (4 audit groups of 3) to ensure all delegates get the attention necessary to ensure that they become effective Auditors.

Day 1:

  • Introduction to MDSAP
  • Specific QMS Requirements of MDSAP
  • 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
  • Purpose of Internal Audits
  • The Audit Process
  • Selecting the Audit Team & Audit Behaviour (Assumptions, Effective Listening, Dealing with Conflict)
  • Tools available to Auditors
  • Review of Internal Quality Audit Procedure
  • MDSAP Internal Audit Preparation

Day 2:

  • MDSAP Internal Audit Preparation (follow on from day 1)
  • Practical on site MDSAP Internal Audit
  • Evaluating and Reporting the Audit

Delegates must attend both days to receive a Certificate of Attendance

Who should attend?

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  • Any person in the organisation with responsibility for conducting internal audits to MDSAP requirements
  • Departmental managers and supervisory staff new to MDSAP
  • Quality Managers, Quality Engineers and supervisory staff new to MDSAP
  • Staff with responsibility for designing and implementing quality systems
  • Personnel responsible for supplier / external audits
  • It is desirable, but not essential that personnel attending this course have a basic knowledge of ISO 13485: 2016
  • It is not necessary for attendees to have any prior knowledge of experience of internal auditing to get the best out of this course.

What will I learn?

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Participants achieve the following learning outcomes from the programme;

  • Understand the importance of internal auditing within a Quality Management System
  • Understand the responsibilities of Internal Auditors
  • Conduct an effective internal audit e.g. plan and prepare for an internal audit against the organisation’s documented procedures and specific sections of:
    o   the Canadian Medical Devices Regulation SOR/98/28
    o   the Japanese PMD Act 2014
    o   the Brazilian ANVISA RDC 16/2013 GMP for Medical Devices and IVDs
    o   the Australian Therapeutic Goods (Med. Dev.) Regulations SR 2002 No. 236
    o   the US QSR 21 CFR part 820
  • Collect and analyse evidence objectively
  • Evaluate and report the results of a MDSAP internal audit

Who are the tutors?

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How do we train and support you?

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In-House Courses
For In-House courses, the Tutor will contact the Course Organiser in advance to discuss the programme in more detail in order to tailor it specifically to the organisation.

Course Manual
Delegates will receive a very comprehensive course manual.

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SnapshotSnapshot

Duration
2 training days
Course Times

9.00am to 3.00pm

Delivery Mode
This programme is available In-House

MDSAP Internal Quality Auditor

Duration: 2 days
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