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Quality is always the result of excellent work without compromise.​

MMD-109    Management Overview on 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
  • Structure & scope of the MDSAP audit program
  • Comparison between MDSAP and other Quality Management System (QMS) audits
  • The role of management in MDSAP
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-day 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.
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​All of our training modules are claimable under HRD Corp.

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©  Ampro Solutions Sdn Bhd 2023
  • Home
    • About Us
    • Authorized Training Partner
  • Our Services
    • On-Site Training
    • Off-Site Training
    • Coaching
    • Audit Support
    • Consultation Services >
      • Energy Management >
        • Remote Power Management Services
      • Management Systems >
        • ISO 50001 Energy Management System
        • ISO 9001 Quality Management System​
        • ISO 14001 Environmental Management System
        • ISO 45001 Occupational Health and Safety Management System
        • IATF 16949 International Automotive Task Force
        • ISO/IEC 17025 Testing and Calibration Laboratories
        • ISO 13485 Quality Management for Medical Devices
        • AS 9100 Quality Management System for Aerospace Industry
        • ISO 20000 IT Service Management
        • ISO 22301 Business Continuity Management
        • ISO 31000 Risk Management
        • ISO 37001 Anti-Bribery Management System
        • ISO 55000 Asset Management
        • TL 9000 The Telecom Quality Management System
        • Food Safety Management System
        • Integrated Management System (IMS)
      • The Malaysian Standard for Sustainable Palm Oil Production (MSPO) >
        • General Differences between MSPO and RSPO
        • Deadlines for MSPO Certification
        • MSPO Certification Process
        • Photo Gallery
      • Business Continuity Management >
        • How We Can Assist You
      • Halal Certification >
        • Certification Scheme
      • Safety and Health Officer Support
  • Training Courses
    • Soft Skills >
      • Leadership & Supervision Skills
      • Motivation & Teambuilding
      • Communication & Interpersonal Skills
      • Presentation & Public Speaking Skills
      • Clerical & Administrative Skills
      • Customer Relationship Management Skills
      • Negotiation Skills
      • Sales & Marketing
      • Creative Thinking & Problem Solving
      • Human Resource
      • Microsoft Office
    • Business Management >
      • Purchasing & Logistic
      • Supply Chain Management
      • Process Improvement & Core Tools
      • Responsible Business Alliance (RBA) and Sedex Members Ethical Trade Audit (SMETA)
      • Lean & Six Sigma
      • Electrical & Electronics
      • Project Management
      • Industry 4.0
    • Manufacturing Operations >
      • ISO 50001 Energy Management System / Energy System
      • ISO 9001 Quality Management System
      • ISO 14001 Environmental Management System
      • ISO 45001 Occupational Health and Safety Management System
      • ​IATF 16949:2016 International Automotive Task Force
      • ISO/IEC 17025 Testing and Calibration Laboratories
      • ISO 13485 Quality Management System for Medical Devices
      • AS 9100 Quality Management System for Aerospace Industry
      • ISO 22000 IT Service Management
      • ISO 22301 Business Continuity Management
      • ​ISO 31000 Risk Management
      • ​ISO 37001 Anti-Bribery Management System
      • ​ISO 55000 Asset Management
      • Food Safety Management System
      • TL 9000 Telecom Quality Management System
      • Integrated Management System
    • Health & Safety >
      • Occupational Health & Safety
      • First Aid
      • Fire Safety
      • Transportation Safety
    • Malaysian Standard for Sustainable Palm Oil Production (MSPO)
  • Events
    • Remote Online Training
    • Public Training in Johor Bahru
    • Public Training in Kuala Lumpur
    • Online Registration
  • External Info
    • Human Resource
    • Environment
    • Health & Safety
  • Contact Us
    • Career Opportunities