MDSAP Internal Quality Auditor

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.

Delivery Mode

  • Public
    Programmes

    Dates
    09 - 10 Oct 2024
  • Classroom
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  • Virtual
    Training
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  • Customised
    In-Company
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SnapshotSnapshot

Course Code
LS004

What's covered?

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 Australia; Therapeutic Goods (Medical Devices) Regulations SR 2002 No. 236
    o Brazil; ANVISA RDC 16/2013 GMP for Medical Devices and IVDs
    o Canada; Canadian Medical Devices Regulation SOR/98/28
    o Japan; PMD Act 2014
    o USA; QSR 21 CFR Part 820
  • 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

Please Note: For in-house courses a practical audit within the company forms the basis of Day 2 of this course. 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. For this reason, also it is essential that all participants and auditees who participate in the course must each have use of an individual laptop. For public courses the audit conducted on Day 2 of the course will be performed on the basis of a case study.

Delegates must attend both days to receive a Certificate of Attendance

Who should participate?

  • 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?

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?

Gerry Burke

Gerry is a self-motivated medical industry professional with knowledge and experience of remediation in the highly regulated medical device, pharmaceutical and biotechnology markets, in particular sterile products. Skilled in developing and implementing strategic remediation plans, for example those aimed at DHF completion and CAPA compliance, including completion of verification, validation and effectiveness actions. Gerry has an excellent track record in Quality Systems, Validation and Risk Management projects in Medical Industry projects. Recent projects have included; Design History File remediation, Risk Management according to ISO 14971, preparation and updating of pFMEA, dFMEA, Risk management Plans, Risk management reports, and change control optimisation for deviations. Gerry implements a hands on approach to problem solving, project development and remediation activities.


John Lafferty

John Lafferty is a Quality professional with over 25 years experience in the medical device and pharmaceutical industry. John joined SQT as a tutor in 2007. Prior to that, John spent many years working in the Medical Devices/ Pharmaceutical sectors – the final six years of which were as a Senior Manager of a multinational Medical Devices plant where he managed the Quality and Regulatory Systems. John completed his Lean Six Sigma Black Belt training through SQT in 2009 and derives great benefit from applying the techniques that he learned to Risk Management and Validation in a Life Sciences setting. “It is great to be able to bring this knowledge, and the experience gained from ongoing involvement with Life Sciences companies, into the classroom,” he says.

John passionately believes that the key to success in Life Sciences Manufacturing is the relentless application of Risk Management, Variation Reduction and Good Validation Practices. As the SQT tutor for Technical Writing Skills, John believes that good written communication skills are vital for any Life Sciences professional.

John holds the following qualifications: a Bachelor of Technology in Manufacturing Technology, a Six Sigma Black Belt, a Certificate in Training & Continuing Education and a Certificate in Quality Management. John is a member of the following committees relating to Risk Management of Medical Devices; ISO TC 210 – Medical Devices Technical Committee and CEN/ISO JWG1 – Joint Working Group on Risk Management.

One of John’s greatest achievements, in recent years, has been the development of the MDSAP and MDSAP Internal Auditor courses in response to demand from SQT’s loyal client base.


How do we train and support you?

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.

John Lafferty

Duration: 2 days **Public Price: £780
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  • 09 - 10 Oct 2024
    Location: Virtual Book Date

John Lafferty

Duration: 2 days
Classroom: £780Virtual Training: £695
Hide
  • 09 - 10 Oct 2024
    Delivery: Virtual Training
    Location: Virtual
    Book Date

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