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Introduction to Quality Management

This training provides practical knowhow and tools to start implementing Quality practices into your development.

This Introduction to Quality Management training covers essential elements and case examples for people to advance into medical Quality roles. Next to this, it provides practical knowhow and tools to start implementing Quality practices into your development.

Target group

  • Researchers who want to implement basic Quality practises into their development and research.
  • Candidates who want to advance into Quality Assurance roles.
  • Candidates with limited Quality experience who want to have a high-level overview of Medical Quality Management.

About Quality Management

Medical Device or Medicinal Product companies must ensure their product meets strict Quality requirements. Quality Management is the coordinated activities to direct and control an organization with regard to quality to meet these requirements. An important tool in Quality Management is the Quality Management System(QMS) which includes: Procedures, work instructions, documents, methods and techniques that an organization puts in place to ensure that applicable requirements are met.

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Covered topics:

1

Introduction to Quality

Purpose and Objectives , History of Quality Management , Key Principles
2

Rules and Regulations

Applicable laws & regulation, standards and guidelines, product classification introduction
3

Quality Management System

Introduction to QMS, structure and key elements, implementation

2023 price to be confirmed

2 hours

Medace facilities, Maastricht OR Online

1:1 access to Regulatory and Quality Experts

Experts

Youri van de Beek  – Quality Officer at Medace

Youri van de Beek is responsible for maintaining and improving the Medace Quality Management System on a daily basis. Youri assists projects and clients within Medace by reviewing and updating documentation and completing technical files from a quality point of view.

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About Medace

Medace supports academic groups and companies with innovative medical concepts in need of technical, quality and clinical expertise. Bringing along a broad network, we help you to successfully develop your product into the clinical phase. With our proven pick-and-choose concept we provide you clinical product development compliant with the latest ISO and GMP standards.

Our specialists work together with you and your team in a fully equipped and state of the art biomedical co-working space – whenever it suits you. More about Medace.

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