Udemy
    •  
    •  
    •  
    •  
    •  
    •  
    •  
    •  
Subscribe
Turn what you know into an opportunity and reach millions around the world.
Learn More
Your cart is empty.
Keep shopping
ISO 15378:2017 Awareness Training
Rating: 4.3 out of 5(10 ratings)
22 students

ISO 15378:2017 Awareness Training

Awareness Training of ISO 15378:2017 Certification
Created byPunyam Academy
Last updated 1/2025
English

What you'll learn

  • ISO 15378:2017 standard for Primary packaging materials for medicinal products and its objectives.
  • The requirements of ISO 15378:2017 standard.
  • High-Level Structure (HLS) of ISO 15378:2017.
  • The benefits of ISO 15378:2017 quality management system.
  • Documentation required for ISO 15378:2017 Quality Management System implementation and certification.
  • The quality principles of ISO 15378:2017.
  • Steps involved in achieving certification for ISO 15378:2017 Quality Management System.
  • Documentation structure for ISO 22301 Business Continuity Management Systems

Explore related topics

Course content

5 sections • 7 lectures • 1h 54m total length

  • Overview of ISO 15378:201715:53

    ISO 15378 is a generic document and it does not specify "how" to do, but only states "what" to do. As per the ISO 15378:2017 standard, the quality management system should have documented information and be demonstrable in a manner consistent with the requirements of ISO 15378. The total documentation in the quality management system consists of documented information and it can be in any form.

Requirements

  • There are no specific prerequisites or customary requirements.
  • Familiarity with ISO standards can be helpful but is not mandatory.
  • Understanding basic terminology commonly used in ISO standards may be beneficial.

Description

ISO 15378:2017 Awareness Training course is specifically designed for individuals seeking to gain foundational knowledge of the ISO 15378:2017 standard for primary packaging materials for medicinal products or pharmaceutical packaging. This training course outlines the basic process approach and principles of ISO 15378 standard. Participants will also get a basic understanding of the ISO 15378:2017 requirements and the documents and records that are required for the ISO 15378 implementation and certification. This awareness training course provides knowledge of the certification steps required for ISO 15378 certification.

The ISO 15378:2017 training program includes the following key elements:

  • Overview of ISO 15378 Quality Management System Standard

  • Requirements of the ISO 15378:2017 Standard

  • ISO 15378:2017 Documented information

  • Steps for ISO 15378 Quality Management System installation and certification

Understand the types of  ISO 15378:2017 Quality Management System documents required for the implementation of a quality management system and ISO 15378:2017 certification. Documentation required for ISO 15378:2017 Quality Management System implementation and certification. Know Quality management principles useful for organizations involved in the design, manufacture, and supply of primary packaging materials for medicinal products. Learn about the key benefits of implementing the ISO 15378:2017 Quality Management System. and Learn the process steps for obtaining ISO 15378:2017 certification.

Who this course is for:

  • Employees and Managers of companies involved in the design, manufacture, and supply of primary packaging materials for medicinal products
  • Entrepreneurs
  • Quality management system consultants / ISO 15378 consultants
  • Graduate students
  • Individuals seeking certified awareness training on ISO 15378:2017
  • People looking to start a career in quality management systems in the pharmaceutical sector

Report abuse