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MDSAP Implementation and Self Assessment for Medical Device Manufacturers

MDSAP Implementation and Self Assessment for Medical Device Manufacturers

$199.00
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MDSAP Implementation and Self-Assessment for Medical Device Manufacturers



Course Overview

This comprehensive course is designed to provide medical device manufacturers with the knowledge and skills necessary to implement the Medical Device Single Audit Program (MDSAP) and conduct self-assessments to ensure compliance with regulatory requirements.



Course Objectives

  • Understand the MDSAP program and its benefits
  • Learn how to implement MDSAP in their organization
  • Conduct self-assessments to ensure compliance with MDSAP requirements
  • Identify and mitigate risks associated with non-compliance
  • Improve overall quality management system (QMS) effectiveness


Course Outline

Module 1: Introduction to MDSAP

  • Overview of MDSAP and its history
  • Benefits of MDSAP participation
  • MDSAP structure and participating countries
  • Regulatory requirements and standards

Module 2: MDSAP Requirements

  • MDSAP audit process and procedures
  • Quality management system (QMS) requirements
  • Risk management and control
  • Design and development controls
  • Production and service controls
  • Corrective and preventive actions (CAPA)

Module 3: Implementing MDSAP

  • GAP analysis and readiness assessment
  • Developing an MDSAP implementation plan
  • Establishing an MDSAP team and roles
  • Training and awareness programs
  • Documentation and record-keeping requirements

Module 4: Self-Assessment and Audit Preparation

  • Self-assessment techniques and tools
  • Audit preparation and planning
  • Audit checklist development
  • Audit execution and reporting
  • Corrective actions and follow-up

Module 5: Risk Management and Control

  • Risk management principles and methodologies
  • Risk assessment and prioritization
  • Risk control and mitigation strategies
  • Risk monitoring and review

Module 6: Quality Management System (QMS) Requirements

  • QMS principles and standards (ISO 13485)
  • QMS documentation and record-keeping
  • QMS implementation and maintenance
  • QMS auditing and continuous improvement

Module 7: Design and Development Controls

  • Design and development principles and requirements
  • Design input and output requirements
  • Design verification and validation
  • Design transfer and documentation

Module 8: Production and Service Controls

  • Production and service principles and requirements
  • Production planning and control
  • Production and service documentation
  • Production and service monitoring and control

Module 9: Corrective and Preventive Actions (CAPA)

  • CAPA principles and requirements
  • CAPA process and procedures
  • CAPA documentation and record-keeping
  • CAPA effectiveness and follow-up

Module 10: MDSAP Audit and Assessment

  • MDSAP audit process and procedures
  • Audit preparation and planning
  • Audit execution and reporting
  • Audit follow-up and closure


Course Features

  • Interactive and engaging: Learn through a mix of lectures, discussions, and hands-on exercises
  • Comprehensive and up-to-date: Covers all aspects of MDSAP implementation and self-assessment
  • Personalized learning: Learn at your own pace and convenience
  • Practical and real-world applications: Learn from real-world examples and case studies
  • High-quality content: Developed by expert instructors with extensive experience in MDSAP
  • Certification: Receive a certificate upon completion issued by The Art of Service
  • Flexible learning: Access course materials 24/7 from any device with an internet connection
  • User-friendly: Easy-to-use platform with clear navigation and minimal technical requirements
  • Mobile-accessible: Access course materials on-the-go from your mobile device
  • Community-driven: Connect with other participants and instructors through discussion forums
  • Actionable insights: Gain practical knowledge and skills that can be applied immediately
  • Hands-on projects: Apply your knowledge and skills to real-world scenarios
  • Bite-sized lessons: Learn in short, manageable chunks
  • Lifetime access: Access course materials for a lifetime
  • Gamification: Engage with interactive elements and track your progress
  • Progress tracking: Monitor your progress and stay on track


Certification

Upon completion of the course, participants will receive a certificate issued by The Art of Service, a recognized leader in professional training and certification.

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