ISO 15378:2017 Awareness Training Program on Primary Packaging Materials for Medicinal Products
Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) based on ISO 15378:2017
This course is certified by Exemplar Global.
This 1-day training program is designed to provide a comprehensive understanding of the ISO 15378:2017 standard, which is specific to the quality management system for primary packaging materials for medicinal products. The training will cover the application of ISO 9001:2015 with a special focus on Good Manufacturing Practices (GMP).
- The training program will be focused, interactive and learning based.
- The training will provide the participants a forum to freely interact with our qualified trainers and auditors.
- Get an overview of Primary Packaging Materials for Medicinal Products.
- Understand the requirements of the standard ISO 15378:2017.
This training is ideal for:
- Management representatives
- Engineers and managers in middle and senior management
- Professionals involved in design, R&D, manufacturing, quality control, quality assurance, material management, and general management
In this program, you will learn the following:
- Overview of Primary Packaging Materials for Medicinal Products.
- Requirements of the standard ISO 15378:2017.
- Implementation of GMP and Quality Management Systems.
- PDCA Cycle and Risk-based thinking.
- Clarifications on Certification Process for ISO 15378:2017.
The ISO 15378:2017 is specific industry sector related Quality Management System Standard, for designing and implementing Quality Management System, with special reference to Good Manufacturing Practices (GMP) for Primary Packaging Materials for Medicinal Products.
- Enhance your understanding of ISO 15378:2017 and its application in the industry.
- Improve your organization's compliance with GMP and quality management standards.
- Gain practical insights into the certification process and risk management.
Participants will learn through lectures, case studies, group exercises and discussions.
The course content and structure are developed by the domain experts from TÜV SÜD. With immense experience and knowledge of the relevant standards, our team of product specialists and technical experts at TÜV SÜD have developed the course content based on the current business landscape and market requirements.
- Certificate of participation from TÜV SÜD Academy US will be issued to participants at the end of the program.