MDSAP Internal Quality Auditor

This practical two-day course develops both understanding and capability in internal auditing under the MDSAP framework. Topics include: 

• Introduction to MDSAP and its global scope 
• Regional regulatory requirements: Australia, Brazil, Canada, Japan, USA 
• Relationship of MDSAP to ISO 13485:2016 and US QMSR 
• Internal audit purpose, process and preparation 
• Selecting audit teams and effective auditor behaviours 
• Tools and techniques available to auditors 
• Internal quality audit procedure review 
• Practical audit exercises (case study or in-company audit) 
• Evaluating evidence and reporting audit results 

On Day 2, learners participate in a practical internal audit exercise, which may take the form of a live in-company audit or a structured case study (for Public courses), providing valuable experience in preparing for, conducting and reporting on an MDSAP internal audit. 

Content can be tailored to reflect your organisation’s specific processes, risk profile and regulatory setting. 

This programme is designed for individuals responsible for conducting internal audits against MDSAP requirements.  

The training is particularly beneficial for: 

• Quality Managers, Quality Engineers and Supervisors new to MDSAP 
• Departmental Managers and staff with audit responsibilities 
• Personnel responsible for supplier or external audits 
• Staff involved in designing or implementing quality systems 

A basic knowledge of ISO 13485:2016 is helpful but not essential. No prior internal auditing experience is required.  A good standard of written and spoken English is important to engage effectively with this programme. 

On successful completion of this course, learners will be able to: 

• Explain the purpose and importance of internal auditing in a Quality Management System. 
• Identify and interpret the MDSAP requirements of Australia, Brazil, Canada, Japan and the USA. 
• Map regulatory requirements to ISO 13485:2016 and US QMSR 21 CFR Part 820. 
• Plan and prepare for an internal audit against MDSAP requirements. 
• Apply effective audit techniques, including evidence collection, analysis and reporting. 
• Demonstrate professional auditor behaviours, such as active listening and constructive communication. 
• Evaluate audit findings and prepare clear, structured reports. 

These outcomes ensure that learners return with the practical skills and knowledge necessary to perform effective internal audits against global MDSAP requirements. 

Our tutors are industry specialists with extensive experience in medical device regulation, auditing and quality systems. Each Tutor brings a wealth of industry experience, sector-specific insights and a passion for practical training. Their focus is on building learner confidence through engagement, hands-on exercises and personalised support. 

Both provide learners with expert guidance, practical knowledge and ongoing support throughout the training. 

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.

Our training approach is practical, highly interactive and discussion-based, with flexibility to meet organisational needs 

• Pre-training consultation for in-company courses to tailor content to organisational needs 
• Emphasis on industry specific application through practical exercises, case studies and group activities that reinforce key concepts and encourage active participation. 
• Access to comprehensive course material that is regularly reviewed and updated to reflect the latest industry standards and guidance. 
• Live training is available virtually or delivered onsite to suit the needs of the team 
• Real-time support from expert tutors 

Class sizes are generally limited to 10-12 participants to support personalized learning and individual support. 

Learners who complete this course often continue to deepen their skills in: 

• ISO 13485:2016 & The Medical Devices Regulation (CE Marking Process) 
• Internal Auditing for Manufacturers of Medical Devices 
• Medical Device Risk Management and ISO 14971:2019 
• Technical Writing Skills