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Lead Auditor Training for MDSAP (Medical Devices Single Audit Program)

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Seminar Content

Omnex is an international training provider and offers this 5-day course on MDSAP to cover the requirements for and the auditing of the Medical Devices Single Audit Program (MDSAP) as a lead auditor. The MDSAP specifies requirements for combined ISO 13485:2016 and compliance requirements for all participating Regulatory Authorities.

Many medical device companies are utilizing ISO 13485 as a platform to build their business management systems because of its value or due to requirements by customers and/or regulators to hold third party certification. The MDSAP offers further value by adding an Audit Model that is recognized by various countries’ Medical Device(s) Regulating Authorities. Currently Australia/TGA, Brazil/ANVISA, Canada/HC-CAMDCAS, Japan/MHLW and US/FDA have accepted the MDSAP as either supportive or alternative to their Routine Inspections.

If your company participates or plans to participate in the MDSAP, it is inevitable that you be ready for any planned or unannounced audits.

Who Should Attend

This seminar is designed for Management Representatives, MDSAP Implementation Teams, Internal Auditors and others who would like to learn the MDSAP auditing process for management systems based on ISO 13485 using MDSAP Audit Model.

Recommended Training and/or Experience

  • A solid understanding of quality management systems conforming to ISO 13485 and an understanding of applicable regulatory requirement is required.
  • A minimum of six months of relevant experience is recommended.
  • Participants must successfully complete the pre-class exercises

Seminar Materials

Each participant will receive a seminar manual and a group workbook that includes auditing case studies.

Seminar Goals

  • Understand the application of MDSAP
  • Understand the relationships between ISO 13485 and participating regulatory authority compliance requirements
  • Relate the quality management system and regulatory requirements to the organization’s medical devices, and provision of related services
  • Understand MDSAP Audit Model and Audit Trail
  • Understand the application of the regulations, and other considerations that are relevant to the management system, and the conduct of MDSAP audit.
  • Practice personal attributes necessary for the effective and efficient conduct of a management system audit.
  • Establish, plan and task the activities of an audit team.
  • Communicate effectively with the auditee and AO.
  • Organize and direct audit team members.
  • Understand conflict management principles.

Seminar Outline

Day One

  • Introduction and Welcome
  • Chapter 1 – Introduction to MDSAP
  • Chapter 2 – The MDSAP Explained
    • - MDSAP Written Exercise 1 (individual)
  • Chapter 3 – Overview of MDSAP Audit Model Requirements
    • - MDSAP Group Exercises (Audit Scenarios)

Day Two

  • Chapter 3 – Overview of MDSAP Audit Model Requirements (cont’d)
    • - MDSAP Group Exercise (Audit Scenarios)
    • - Understanding MDSAP Examination (individual)

Day Three

  • Introduction to MDSAP Audit Trail
    • - Breakout Exercise 1: Scope and Objectives
  • Management of Audit Programs
  • MDSAP Audit Planning and Preparation
    • - Breakout Exercise 2: Audit Duration Calculation
    • - Breakout Exercise 3: Documentation Review
    • - Breakout Exercise 4: Audit Plan
  • Performing the Audit

Day Four

  • Writing Nonconformity Statements
    • - Breakout Exercise 5: Writing Nonconformities
  • Closing Meeting
  • Completing the Audit Report
  • Corrective Action and Closeout
    • - MDSAP Auditing Examination (individual)

Day Five

  • Leading Audit Teams – Conflict Resolution
    • - Conduct MDSAP Mock Audit
    • - MDSAP Lead Auditor Examination (individual)

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