ISO 15378:2017 Primary Packaging Materials For Medicinal Products - Particular Requirements For The Application Of ISO 9001:2015, With Reference To Good Manufacturing Practice (GMP) Internal Auditor Training Course

The purpose of this course is to equip learners with an understanding of the concept of Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices and provides an overview of the purpose and requirements of ISO 15378:2017 as a tool for business improvement.

2 Days Virtual Class English Identifier: 105425999
ISO 15378:2017 Primary Packaging Materials For Medicinal Products - Particular Requirements For The Application Of ISO 9001:2015, With Reference To Good Manufacturing Practice (GMP) Internal Auditor Training Course

Course Overview

What you'll learn

Upon completion of this course, learners will be able to:

  • Understand the basic requirements of ISO 15378:2017
  • Explain the purpose of GMP for cosmetic products
  • Explain the purpose, content and guidance provided by ISO 15378:2017
  • Understand the purpose and benefit of GMP requirements in addition to ISO 9001 requirements
  • Understand and interpret the structure and requirements of clauses 3 to 10 of ISO 15378:2017

Virtual Course requirements:
To ensure your access to the virtual course and to gain the most out of this training we request all learners have:

  • Reliable internet access (High speed)
  • Computer with microphone and camera capabilities

 Assessment and group activities for this course requires your camera to be turned on. Background effects such as blurring can be used for preserving privacy. 

Who This Course Is For

This course is designed for those wishing to learn to conduct internal audits of ISO 15378:2007, according to ISO 19011 guidance.

NOTE: Learners are required to obtain a copy of the ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) Standard. Learners should familiarise themselves with the standard prior to attending the training course.

About this course

The purpose of this course is to equip learners with an understanding of the concept of Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices and provides an overview of the purpose and requirements of ISO 15378:2017 as a tool for business improvement.

Course Content:

  • Introduction to development of ISO 15378 and comparisons to ISO 9001
  • Clause 3: Terms and definitions
  • Clause 4: Context of Organisation
  • Clause 5: Leadership
  • Clause 6: Planning
  • Clause 7: Support
  • Clause 8: Operation
  • Clause 9: Performance Evaluation
  • Clause 10: Improvement
  • Annex D Guidance on verification, qualification and validation requirements for primary packaging materials
  • Auditing for Continual Improvement
  • Audit Definition, Types and Principles
  • Roles and Responsibilities of Auditors
  • The Audit Process
  • Preparing for the Internal Audit
  • Conducting the Audit
  • Audit Review

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