MDSAP Internal Quality Auditor

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

• 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.

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

• 

  Gerry Burke

  Gerry is a self-motivated medical industry professional with kn...

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• 

  John Lafferty

  John Lafferty is a Quality professional with over 25 years expe...

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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.