MMD-110    Medical Device Single Audit Program (MDSAP) Internal Auditor Training

• Overview
• Course Objectives
• Course Content
• For Whom
• Schedule and Hours

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The need for self-assessment is specified and achieved through internal auditing of the Quality Management System which aids regulatory compliance as well as identifies opportunities for improvement. This course is designed to give participants familiar with ISO 13485:2016 the knowledge and skills needed to undertake an unbiased and constructive Quality Management System audit in line with the generic guidelines laid down in ISO 19011. Participants will learn the skills and techniques of a process audit and how to communicate the findings so as to increase the effectiveness of the organisation’s management.

Participants will be led by an experienced trainer whom, in addition to being a CE Marking auditor, technical file reviewer and Quality Systems/ GMP auditor, has 3 decades of assessment, training and quality assurance as well as management system development experience. Participants will engage in small group activities, lively debate and case studies, along with instructor led segments. Participants will learn how to apply these principles to produce effective internal audits of medical device manufacturing in preparation for external audits by MDSAP Auditing Organisations.

Participants will be able to:

• Improve auditing skills focused on regulatory auditing
• Understand the responsibilities of Internal Auditors
• Understand how to prepare and host a successful MDSAP audit

The course covers tutorials, discussions, case study and facilitated activities on the following:

• MDSAP Auditing Approach
• Overview of Internal Auditing
• Pre-Audit Preparation
• Conducting the Audit
• Reporting the Audit
• Follow-up after the Audit
• Risk Based Approach in Internal Auditing

This course is designed for company staff with audit responsibility for their organisation’s ISO 13485 Quality System or will be undertaking Internal Quality Audits. It is suitable for all functions and levels tasked:

• to carry out internal audits on manufacturing activities
• to organise the audit program for their GMP
• to train or guide other internal auditors.

This is a ​2-days programme.
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This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
 
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.

We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
​All of our training modules are claimable under HRD Corp.