MMD-109    Awareness on the Medical Device Single Audit Program (MDSAP) 

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

<

>

ThThe Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. Regulatory Authorities participating in the MDSAP include the Australian TGA, Brazil’s ANVISA, Health Canada, Japan’s MHLW & PMDA and the US FDA.

Top together with senior management are seen as core to the strategization, deployment and continued maintenance in complying to regulatory and MDSAP requirements. They hence will be assessed during the audits on their familiarity on these and other compliance matters.

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 be in a position to understand the MDSAP framework as well as their roles when hosting such audits.

Participants will gain a thorough understanding of:

• The MDSAP fundamentals
• The principles and approach of the MSDAP Program
• The process structure and audit tasks.
• The approach of an auditing organization

• Overview of MDSAP
  
• Concept of MDSAP
  
• Transition to MDSAP
  
• MDSAP Audit Program, Sequence & Model
  
• Audit Approach
  
• MDSAP Nonconforming Grading
  
• MDSAP Post Audit Activities
  

The management team operating under their company’s QMS and those with executive oversight of:

• Device Marketing Authorization and Facility Registration
• Measurement, Analysis and Improvement
• Adverse Events and Advisory Notices Reporting
• Design and Development
• Production and Service Controls
• Purchasing and Supply Chain

This is a ​1 or 2-days programme.
​
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.