ISO 15378 Training – Internal Audit Course on ISO 15378

ISO 15378 Training – Understand occupational health and safety management in organizations. Grasp the main structure of an occupational health and safety management system in enterprises. Promote the application of a management system, Improve productivity and quality in line with the system.

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GENERAL INTRODUCTION TO ISO 15378 TRAINING

ISO 15378:2017 – PPM for Medicinal Products – Quality Management System Standard for designing and implementing a Quality Management System with special reference to Good Manufacturing Practices (GMP) for Primary Packaging Materials of Medicinal Products.

This course is structured to provide an understanding of ISO 9001 requirements, the knowledge and skills necessary to evaluate an organization’s Quality Management System combined with case studies, role-plays, and exercises.

This course is structured to provide an understanding of ISO 9001 requirements, the knowledge and skills necessary to evaluate an organization’s Quality Management System combined with case studies, role-plays, and exercises.

The competence of an auditor is crucial to the effectiveness of any company’s audit team and ultimately to the success of the organization’s management system. This course will help participants understand the role of the auditor and equip them with the knowledge and expertise to perform effective internal audits.

WHO SHOULD ATTEND THE ISO 15378 COURSE

  • Management representatives
  • Engineers and managers (middle and senior management) actively involved in Design, R&D, Production, Quality Control, Quality Assurance, Materials Management, and General Management.

MAIN TOPICS OF THE ISO 15378 TRAINING

Part 1:

  • Requirements of ISO 15378:2017
  • Overview of Primary Packaging Materials for Medicinal Products
  • Introduction to ISO 15378:2017
  • Understanding structure, terminology, and new concepts
  • Quality concepts & Process approach
  • Quality management principles, quality concepts, and process approach
  • Quality Management System requirements according to ISO 9001:2015
  • Application of Good Manufacturing Practices (GMP)
  • GMP requirements for printed primary packaging materials
  • Changes
  • Adoption of High-Level Structure (HLS)
  • Key differences between ISO 15378:2015 and ISO 15378:2017
  • Documentation requirements
  • Transition guidance

Part 2:

  • Auditing concepts and principles
  • Roles and responsibilities of Auditors
  • Planning Internal Audits
    o Audit plan and Checklist
    o Communication factors
  • Conducting an Audit
    o Opening meeting
    o Collecting objective evidence/evaluation
    o Effective interview techniques
    o Identifying and recording nonconformities
  • Reporting Audit results
    o Conducting the closing meeting
    o Preparing and distributing the audit report
  • Corrective actions and follow-up
    o Corrective and preventive actions
    o Planning follow-up
    o Monitoring corrective actions
  • Exam
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WHAT WILL YOU GAIN FROM THE ISO 15378 TRAINING?

After successfully completing this ISO 15378 Implementation training, participants will understand:

  • Overview of primary packaging materials for pharmaceuticals
  • Requirements of ISO 15378:2017 standard
  • Implementation of GMP and Quality Management System
  • Internal auditing

BENEFITS THE ISO 15378 TRAINING BRINGS YOU

  • Understand the structure of ISO 15378:2017
  • Learn the importance and benefits of the ISO 15378 Quality Management System
  • Understand the key requirements, terminology, and definitions of ISO 15378
  • Learn important concepts such as risk-based thinking, process approach, Plan – Do – Check – Act cycle, and quality management principles
  • Be prepared to engage in the ISO 15378 implementation process, Quality Management, and continuous improvement
  • Take steps to ensure quality is at the center of your organization
  • Attract and retain customers by better meeting their current and future needs
  • Learn techniques to create and manage documents and records related to the ISO 15378 Quality Management System, essential for products and services provided to meet customer and regulatory requirements
  • Fill gaps in your professional knowledge
  • Understand documentation and record-keeping practices for ISO 15378
  • Understand inspection and verification techniques to ensure compliance with ISO 15378 requirements
  • Understand GMP requirements for printed primary packaging materials
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