MDSAP: The Medical Device Single Audit Programme

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

• 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

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

• 

  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.