ISO 15378 TRAINING COURSE – SQS GLOBAL

Gain practical knowledge of ISO 15378:2017 to establish, implement, and continually improve a Quality Management System (QMS) integrated with Good Manufacturing Practices (GMP) for manufacturers of primary packaging materials for medicinal products.

✅ Curriculum aligned with the requirements of ISO 15378:2017

✅ Practical implementation guidance from industry experts

✅ Certificate of Completion awarded upon successful course completion

GET 10% OFF – REGISTER EARLY
ISO 15378 TRANING COURS

ISO 15378 TRAINING COURSE

Gain practical knowledge of ISO 15378:2017 to establish, implement, and continually improve a Quality Management System (QMS) integrated with Good Manufacturing Practices (GMP) for manufacturers of primary packaging materials for medicinal products.

✅ Curriculum aligned with the requirements of ISO 15378:2017

✅ Practical implementation guidance from industry experts

✅ Certificate of Completion awarded upon successful course completion

GET 10% OFF – REGISTER EARLY
ISO 15378 TRANING COURS

ISO 15378:2017 Training Course Content

The ISO 15378:2017 Training Course is designed to provide participants with the knowledge and practical skills required to understand, implement, and maintain a QMS for primary packaging materials used in medicinal products.

The program consists of two modules: ISO 15378:2017 Awareness Training and ISO 15378:2017 Internal Auditor Training, enabling participants to gain a comprehensive understanding of the standard, Good Manufacturing Practices (GMP) requirements, internal auditing techniques, and continual improvement of quality management systems.

ISO 15378:2017 Awareness Training

The first three sessions focus on providing a comprehensive overview of ISO 15378:2017, including its core requirements and GMP principles for primary packaging materials used in medicinal products. Participants will learn how to establish, implement, and maintain an effective Quality Management System (QMS) within their organizations.

This session provides participants with a solid foundation in Quality Management Systems (QMS) for primary packaging materials used in medicinal products. Participants will gain an understanding of the structure of ISO 15378:2017, key terminology, industry concepts, and the relationship between ISO 15378, ISO 9001, and Good Manufacturing Practices (GMP).

Course Content

  • Introduction to Quality Management Systems for primary packaging materials used in medicinal products
  • Structure and scope of ISO 15378:2017
  • Key terms and definitions
  • Relationship between ISO 15378, ISO 9001, and GMP
  • Applicable regulations and industry guidance for pharmaceutical packaging
  • Benefits of implementing ISO 15378 within an organization
  • Roadmap for implementing and maintaining an ISO 15378 Quality Management System

This session provides an in-depth review of the requirements of ISO 15378:2017 and demonstrates how they can be effectively applied within organizations manufacturing primary packaging materials for medicinal products.

Course Content

  • Context of the organization
  • Leadership and management commitment
  • Risk and opportunity management
  • Resource management
  • Operational planning and process control
  • Performance evaluation
  • Continual improvement of the Quality Management System
  • GMP requirements integrated within ISO 15378

This session guides participants through the development of documented information and the practical implementation of ISO 15378 requirements within daily operations.

Course Content

  • Establishing quality policies and quality objectives
  • Developing procedures and work instructions
  • Control of documented information and records
  • Supplier and raw material management
  • Product traceability
  • Change control and risk management
  • Control of nonconforming products
  • Preparing for ISO 15378 certification audits

ISO 15378:2017 Internal Auditor Training

The following three sessions are designed to develop participants’ internal auditing competencies. The course covers audit planning, audit preparation, evidence collection, reporting of audit findings, and the application of ISO 19011 auditing principles to support the effective maintenance and continual improvement of an ISO 15378 Quality Management System.

This session introduces the principles of internal auditing in accordance with ISO 19011 and equips participants with the knowledge and skills required to plan, organize, and prepare effective internal audits.

Course Content

  • Introduction to ISO 15378 internal auditing
  • Quality auditing principles
  • Roles and responsibilities of internal auditors
  • Developing an internal audit programme
  • Planning ISO 15378 internal audits
  • Preparing audit checklists
  • Preparing audit documentation and records
  • Identifying risks and opportunities during audits

This session focuses on conducting effective internal audits, gathering objective evidence, identifying nonconformities, and implementing corrective actions to support continual improvement.

Course Content

  • Interviewing techniques and collection of audit evidence
  • Conducting on-site audits
  • Identifying nonconformities (NCRs)
  • Classification of nonconformities
  • Root cause analysis
  • Corrective and preventive actions (CAPA)
  • Verification of corrective action effectiveness
  • Internal audit reporting

The final session reviews the key concepts of ISO 15378:2017, GMP requirements for primary packaging materials used in medicinal products, and internal auditing practices before participants complete the final assessment.

Course Content

  • Review of ISO 15378:2017 requirements
  • Review of GMP requirements for pharmaceutical packaging materials
  • Internal audit case study exercises
  • Nonconformity identification workshop
  • Discussion of common implementation challenges
  • Final assessment
  • Course review and closing

REGISTER NOW TO RECEIVE THE TENTATIVE TRAINING SCHEDULE AND SPECIAL OFFER

SQS Global does not apply a standardized training framework for all participants. Each ISO 15378:2017 training program is tailored to the organization’s specific objectives, operational context, and competency requirements, ensuring participants gain relevant knowledge and practical skills that can be effectively applied within their Quality Management System and business operations.

ISO 15378:2017 Training Course Content

The ISO 15378:2017 Training Course is designed to provide participants with the knowledge and practical skills required to understand, implement, and maintain a QMS for primary packaging materials used in medicinal products.

The program consists of two modules: ISO 15378:2017 Awareness Training and ISO 15378:2017 Internal Auditor Training, enabling participants to gain a comprehensive understanding of the standard, Good Manufacturing Practices (GMP) requirements, internal auditing techniques, and continual improvement of quality management systems.

ISO 15378:2017 Awareness Training

The first three sessions focus on providing a comprehensive overview of ISO 15378:2017, including its core requirements and GMP principles for primary packaging materials used in medicinal products. Participants will learn how to establish, implement, and maintain an effective Quality Management System (QMS) within their organizations.

This session provides participants with a solid foundation in Quality Management Systems (QMS) for primary packaging materials used in medicinal products. Participants will gain an understanding of the structure of ISO 15378:2017, key terminology, industry concepts, and the relationship between ISO 15378, ISO 9001, and Good Manufacturing Practices (GMP).

Course Content

  • Introduction to Quality Management Systems for primary packaging materials used in medicinal products
  • Structure and scope of ISO 15378:2017
  • Key terms and definitions
  • Relationship between ISO 15378, ISO 9001, and GMP
  • Applicable regulations and industry guidance for pharmaceutical packaging
  • Benefits of implementing ISO 15378 within an organization
  • Roadmap for implementing and maintaining an ISO 15378 Quality Management System

This session provides an in-depth review of the requirements of ISO 15378:2017 and demonstrates how they can be effectively applied within organizations manufacturing primary packaging materials for medicinal products.

Course Content

  • Context of the organization
  • Leadership and management commitment
  • Risk and opportunity management
  • Resource management
  • Operational planning and process control
  • Performance evaluation
  • Continual improvement of the Quality Management System
  • GMP requirements integrated within ISO 15378

This session guides participants through the development of documented information and the practical implementation of ISO 15378 requirements within daily operations.

Course Content

  • Establishing quality policies and quality objectives
  • Developing procedures and work instructions
  • Control of documented information and records
  • Supplier and raw material management
  • Product traceability
  • Change control and risk management
  • Control of nonconforming products
  • Preparing for ISO 15378 certification audits

ISO 15378:2017 Internal Auditor Training

The following three sessions are designed to develop participants’ internal auditing competencies. The course covers audit planning, audit preparation, evidence collection, reporting of audit findings, and the application of ISO 19011 auditing principles to support the effective maintenance and continual improvement of an ISO 15378 Quality Management System.

This session introduces the principles of internal auditing in accordance with ISO 19011 and equips participants with the knowledge and skills required to plan, organize, and prepare effective internal audits.

Course Content

  • Introduction to ISO 15378 internal auditing
  • Quality auditing principles
  • Roles and responsibilities of internal auditors
  • Developing an internal audit programme
  • Planning ISO 15378 internal audits
  • Preparing audit checklists
  • Preparing audit documentation and records
  • Identifying risks and opportunities during audits

This session focuses on conducting effective internal audits, gathering objective evidence, identifying nonconformities, and implementing corrective actions to support continual improvement.

Course Content

  • Interviewing techniques and collection of audit evidence
  • Conducting on-site audits
  • Identifying nonconformities (NCRs)
  • Classification of nonconformities
  • Root cause analysis
  • Corrective and preventive actions (CAPA)
  • Verification of corrective action effectiveness
  • Internal audit reporting

The final session reviews the key concepts of ISO 15378:2017, GMP requirements for primary packaging materials used in medicinal products, and internal auditing practices before participants complete the final assessment.

Course Content

  • Review of ISO 15378:2017 requirements
  • Review of GMP requirements for pharmaceutical packaging materials
  • Internal audit case study exercises
  • Nonconformity identification workshop
  • Discussion of common implementation challenges
  • Final assessment
  • Course review and closing

REGISTER NOW TO RECEIVE THE TENTATIVE TRAINING SCHEDULE AND SPECIAL OFFER

SQS Global does not apply a standardized training framework for all participants. Each ISO 15378:2017 training program is tailored to the organization’s specific objectives, operational context, and competency requirements, ensuring participants gain relevant knowledge and practical skills that can be effectively applied within their Quality Management System and business operations.

ISO 15378 Training Delivery Options

SQS Global offers ISO 15378:2017 Training through flexible delivery options, enabling organizations and professionals to choose the learning format that best suits their operational needs, schedules, and team size.

On-Site Training

Training is conducted at the client’s facility, allowing participants to learn within their actual operational environment and directly relate course concepts to day-to-day activities.

✅ Reduced travel time and costs

✅ Suitable for group training programs

✅ Customized to organizational needs

Training at SQS Global

Participants attend instructor-led training at SQS Global’s facilities, benefiting from a professional learning environment, practical knowledge exchange, and direct interaction with experienced trainers.

✅ Regularly scheduled training sessions

✅ Professional learning environment

✅ Direct access to experienced trainers

Live Online Training

Participants can join the training remotely from any location while benefiting from structured learning, real-time discussions, and continuous engagement throughout the course.

✅ Flexible schedule and location

✅ Reduced travel expenses

✅ Real-time interaction with trainers

ISO 15378 Training Course Participants

This course is designed for professionals and organizations that are implementing, maintaining, or seeking to understand ISO 15378:2017 Quality Management Systems for primary packaging materials used in medicinal products.

Executive Management Quality (QA/QC/QMS) Production & Engineering Internal Auditors & ISO Personnel
  • Chief Executive Officer (CEO)
  • Deputy General Director / Vice President
  • Department Managers
  • ISO Steering Committee Members
  • Quality Director / Quality Manager
  • QA/QC Manager
  • QA/QC Specialists
  • QMS & GMP Personnel
  • Production Manager
  • Production Supervisors
  • Process / Production Engineers
  • Operations Personnel
  • Internal Auditors
  • ISO 15378 Implementation Team Members
  • Professionals seeking to enhance their expertise in ISO 15378

ISO 15378 Training Course Participants

This course is designed for professionals and organizations that are implementing, maintaining, or seeking to understand ISO 15378:2017 Quality Management Systems for primary packaging materials used in medicinal products.

Executive Management
  • Chief Executive Officer (CEO)
  • Deputy General Director / Vice President
  • Department Managers
  • ISO Steering Committee Members
Quality (QA/QC/QMS)
  • Quality Director / Quality Manager
  • QA/QC Manager
  • QA/QC Specialists
  • QMS & GMP Personnel
Production & Engineering
  • Production Manager
  • Production Supervisors
  • Process / Production Engineers
  • Operations Personnel
Internal Auditors & ISO Personnel
  • Internal Auditors
  • ISO 15378 Implementation Team Members
  • Professionals seeking to enhance their expertise in ISO 15378

Benefits of ISO 15378 Training at SQS Global

Through this training course, participants will gain the knowledge and practical skills required to understand, implement, and maintain an ISO 15378:2017 Quality Management System for primary packaging materials used in medicinal products, while strengthening their understanding of Good Manufacturing Practices (GMP) and quality management best practices.

Professional Knowledge

✅ Understand the structure and requirements of ISO 15378:2017

✅ Gain practical knowledge of GMP for primary packaging materials

✅ Understand quality, traceability, and regulatory compliance requirements

Practical Skills

✅ Learn how to implement and maintain an ISO 15378 Quality Management System

✅ Conduct internal audits in accordance with ISO 19011 guidelines

✅ Identify nonconformities and implement effective corrective actions

Practical Application

✅ Apply ISO 15378 requirements to pharmaceutical packaging operations

✅ Improve process control, risk management, and product traceability

✅ Enhance operational performance through continual quality improvement

After successfully completing the course and passing the final assessment, participants will receive an ISO 15378:2017 Training Certificate of Completion issued by SQS Global. Throughout the program, participants will engage directly with experienced trainers, discuss real-world industry scenarios, and develop practical solutions for implementing quality management systems and GMP requirements.

Special Offer: Participants and organizations enrolling in the training course are eligible for exclusive discounts on ISO 15378 consulting, implementation, and certification services offered by SQS Global.