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Technician Development

Overview

Course Description

The objective of this course is to provide basic knowledge for Technicians Development in the Medical Devices Industry, with topics such as good manufacturing practices, good documentation practices, general aspects of clean rooms and clothing, equipment validation, equipment documentation, management of work orders, interpretation of plans and audits and failures to the quality system. All these topics aimed at ensuring that the Quality System Requirements are met.

At The End Of The Course You Will Be Able To

  • Understand the regulatory framework of medical device manufacture.
  • Apply general understanding of what Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDP) mean in the Medical Device Industry, and why they are relevant in compliance to the quality system.
  • Understand the basic principles of Good Manufacturing Practices (GMPs) in the Medical Device Industry.
    • Definition.
    • Quality system.
    • Cleaning and hygiene.
    • Documentation.
    • Productive process.
    • Quality assurance.
  • Understand the definition, purpose and key elements associated with Good Documentation Practices (GDP).
    • Definition.
    • Purpose and types of documentation.
    • Requirements of good documentation practices.
    • Application of good documentation practices.
  • Learn and review general considerations for cleanrooms and gowning.
  • Know the basic principles in the interpretation of blueprint, generalities and considerations.
  • Understand the concept, function and purpose of Work Orders, as well as the essential elements to generate and close a Work Order.
  • To provide the student with the knowledge of the typical process phases of equipment validation going from defining the requirements for construction to installation and qualification.
    • User Requirement Specification URS.
    • Factory Acceptance test FAT.
    • Installation Qualification IQ.
  • Understand the importance of GMP audits and how they can help companies comply with guidelines set by regulatory authorities.
  • Learn about quality and discuss how quality products are important for safety and efficacy.
  • Apply gained knowledge to solve multiple real case situations throughout the class.

Course Content

  1. Good Manufacturing Practices.
    • Definition.
    • Quality system.
    • Cleaning and hygiene.
    • Documentation.
    • Productive process.
    • Quality assurance.
  2. Good Documentation Practices.
    • Definition.
    • Purpose and types of documentation.
    • Requirements of good documentation practices.
    • Application of good documentation practices.
  3. General Aspects of Clean Rooms and Gowning.
    • Definition of clean room.
    • Considerations within the clean room.
    • Gowning considerations.
    • Types of clean rooms and their classification.
    • Validation of clean rooms.
    • Best practices for equipment qualification and validation
    • Equipment Qualification.
      • What is equipment qualification.
      • Typical steps to validate and qualify equipment.
      • User Requirement Specifications (URS).
      • Factory Acceptance Test (FAT).
      • Installation Qualification (IQ).
  4. Work/Service Orders Management.
    • Concept
    • Function
    • Purpose
  5. Drawings Interpretation.
    • Introduction to technical drawing.
    • Dimensioning and bounding of technical diagrams.
    • Fits and tolerances.
    • Introduction to geometric tolerances.
    • General plans and exploded views.
  6. Audits and Failures to the Quality System.
    • The purpose of the audits.
    • Participation in an audit.
    • Quality system failures.

Description

Learn the basic knowledge for the development of technicians in the medical device industry.

Duration: 10 hours

Modality: Group

Participant limit: 15

Download Course Technical Information

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Course Features

Learn the basic knowledge for the development of technicians in the medical device industry.

Duration: 10 hours

Modality: Group

Participant limit: 15

Download Course Technical Information

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