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Medical Device Single Audit Programme (MDSAP) Training Course

A Comprehensive and Practical Introduction

The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices. This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.

23-24 Mar 2023
+ 2 more dates

Need help?  Enrol or reserve

  • Format: Live online, Classroom
  • CPD: 12 hours for your records
  • Certificate of completion

Overview

The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices.

The MDSAP audit is based on BS EN ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes - with the applicable regulatory requirements of the participating jurisdictions – Australia, Brazil, Canada, Japan and the USA – included as areas of focus. Audits conducted in accordance with the MDSAP follow a closely prescribed process of defined tasks. An MDSAP audit uses a process approach, based on a foundation of risk management, to select samples of procedures and records to examine. The audit focuses on how risks are identified and addressed.

This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.  

Recommended Reading

It is recommended that delegates have access to the MDSAP Audit Guide and ISO 13485:2016 standard prior to attending the course.  

Benefits in Attending

  • Gain a comprehensive overview of MDSAP
  • Enhance your understanding of the MDSAP audit approach
  • Recognize how MDSAP supports the regulations in the participating jurisdictions
  • Understand the MDSAP processes and their interrelationships
  • Learn how to implement the MDSAP audit model

Who Should Attend

  • Quality Management System (QMS) specialists
  • Regulatory Compliance specialists
  • Internal Auditors
  • Regulatory and Quality professionals

Enrol or reserve

The Medical Device Single Audit Programme (MDSAP) course will cover:

Introduction and welcome

Overview of MDSAP

  • Background to MDSAP
  • Benefits for regulators and manufacturers
  • Participating jurisdictions
  • Auditing organizations
  • Interaction with EU regulations for medical devices

MDSAP audit approach

  • MDSAP process sequence
  • MDSAP audit planning
  • Grading of nonconformities
  • Post audit activities
  • MDSAP documents

Management process

  • Audit tasks
  • QMS planning
  • Policy and objectives
  • Management review

Device marketing authorisation and facilty registration

  • Audit tasks
  • Marketing authorization
  • Facility registration
  • Change notification

Syndicate exercise - Management process

  • Feedback and discussion

Measurement, analysis and improvement

  • Audit tasks
  • Data sources
  • Investigations
  • Nonconforming product
  • Post-production information

Adverse events and advisory notice reporting

  • Methodologies
  • Introduction to threat modeling
  • Relation to safety risk management

Syndicate exercise - Measurement, analysis and improvement

  • Feedback and discussion

Q & A

Introduction and recap of Day one

Design and development

  • Audit tasks
  • Regulatory requirements for design and development
  • Design and development planning
  • Risk management
  • Design and development processes
  • Design and development transfer

Syndicate exercise - Design and development

  • Feedback and discussion

Production and service controls

  • Audit tasks
  • Planning of product realization
  • Production control
  • Contamination control
  • Infrastructure
  • Process validation
  • Sterile devices
  • Monitoring and measuring equipment
  • Documents and records
  • Handling, storage and delivery

Syndicate exercise - Product and service controls process

  • Feedback and discussion 

Purchasing

  • Audit tasks
  • Planning of purchasing
  • Purchasing controls
  • Supplier selection
  • Verification of purchased product

Syndicate exercise - Purchasing

  • Feedback and discussion 

Wrap up and Q & A

Enrol or reserve

Eamonn Hoxey
E V Hoxey Ltd

Eamonn Hoxey, is a technical author, trainer and consultant in life science areas including regulatory compliance, quality management, sterility assurance and standards development. Eamonn worked for Johnson & Johnson for 17 years in positions of increasing responsibility for Quality and Regulatory including Vice President of Compliance for J&J’s medical devices companies. Prior to joining J&J, Eamonn spent 16 years with the UK Medical Devices Agency, including six years as Head of Device Technology and Safety.

Eamonn is past chair of ISO TC 210 ‘Quality management and related general aspects for medical devices’ and ISO TC 198, ‘Sterilization of Healthcare products’. He is past chair of the Board of Directors of AAMI.

Dr Hoxey graduated as a Bachelor of Pharmacy and has a Ph.D. in Pharmaceutical Microbiology from the University of Bath. He was designated a Fellow of the Royal Pharmaceutical Society of Great Britain in 2004. He received the BSI Wolfe-Barry medal in 2016 for his contribution to standards development.

 


More details

Book Medical Device Single Audit Programme (MDSAP) Live online/Classroom training

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

23-24 Mar 2023

Live online

09:00-17:30 UK (London) (UTC+00)
10:00-18:30 Paris (UTC+01)
05:00-13:30 New York (UTC-04)
Course code 12573

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 16 Feb

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Not ready to book yet?

for 7 days, no obligation

6-7 Jul 2023

Live online

09:30-17:30 UK (London) (UTC+01)
10:30-18:30 Paris (UTC+02)
04:30-12:30 New York (UTC-04)
Course code 12748

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 01 Jun

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Not ready to book yet?

for 7 days, no obligation

30 Nov-1 Dec 2023

Classroom
Rembrandt Hotel
London

09:00-17:30 UK (London)
Course code 12749

  • GBP 1,299 1,499
  • EUR 1,869 2,149
  • USD 2,137 2,449

Until 26 Oct

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

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Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

Poland

  • LiNA Medical Polska Sp. z o.o.
  • LiNA Medical Sp. z o.o.

Enrol or reserve

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy