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) Introduction 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.
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
Who This Course Is For
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.
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.
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
On completion of this course:
- Learners who are in attendance for the complete course will be issued with a ‘Certificate of Attendance’.
- Learners who pass the Quiz will be issued with a “Certificate of Successful Completion”
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