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ISO 15378 Audit Checklist and Implementation Guide for Pharmaceutical Packaging Materials Manufacturers

ISO 15378 Audit Checklist and Implementation Guide for Pharmaceutical Packaging Materials Manufacturers

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ISO 15378 Audit Checklist and Implementation Guide for Pharmaceutical Packaging Materials Manufacturers



Course Overview

This comprehensive course is designed to provide participants with the knowledge and skills necessary to understand and implement the ISO 15378 standard for pharmaceutical packaging materials manufacturers. Upon completion, participants will receive a certificate issued by The Art of Service.



Course Objectives

  • Understand the requirements of the ISO 15378 standard
  • Develop an audit checklist to ensure compliance with the standard
  • Implement the standard in their organization
  • Conduct internal audits to ensure ongoing compliance
  • Maintain certification through continuous improvement


Course Outline

Module 1: Introduction to ISO 15378

  • Overview of the ISO 15378 standard
  • History and evolution of the standard
  • Benefits of implementing the standard
  • Key concepts and terminology

Module 2: Understanding the Requirements of ISO 15378

  • Clause 4: Quality management system
  • Clause 5: Management responsibility
  • Clause 6: Resource management
  • Clause 7: Product realization
  • Clause 8: Measurement, analysis and improvement

Module 3: Developing an Audit Checklist

  • Understanding the audit process
  • Identifying audit criteria
  • Developing audit questions
  • Conducting a risk-based audit
  • Documenting audit findings

Module 4: Implementing ISO 15378

  • GAP analysis and implementation planning
  • Establishing a quality management system
  • Defining roles and responsibilities
  • Training and awareness
  • Documentation and record-keeping

Module 5: Conducting Internal Audits

  • Audit planning and preparation
  • Audit execution and reporting
  • Audit follow-up and closure
  • Maintaining audit schedules and calendars

Module 6: Maintaining Certification

  • Understanding certification requirements
  • Preparing for certification audits
  • Maintaining compliance through continuous improvement
  • Handling non-conformities and corrective actions

Module 7: Best Practices and Case Studies

  • Industry best practices for pharmaceutical packaging materials manufacturers
  • Case studies of successful ISO 15378 implementation
  • Lessons learned and challenges overcome

Module 8: Interactive Session - Audit Checklist Development

Participants will work in groups to develop an audit checklist based on the ISO 15378 standard.

Module 9: Interactive Session - Implementation Planning

Participants will work in groups to develop an implementation plan for ISO 15378.



Course Features

  • Interactive: Engaging video lessons, quizzes, and interactive exercises
  • Comprehensive: In-depth coverage of the ISO 15378 standard and its implementation
  • Personalized: Learn at your own pace and convenience
  • Up-to-date: Latest information and best practices in pharmaceutical packaging materials manufacturing
  • Practical: Real-world applications and case studies
  • High-quality content: Developed by expert instructors with industry experience
  • Certification: Receive a certificate upon completion issued by The Art of Service
  • Flexible learning: Access the course from anywhere, at any time
  • User-friendly: Easy-to-use platform with mobile accessibility
  • Community-driven: Discussion forums and community support
  • Actionable insights: Practical knowledge and skills to implement immediately
  • Hands-on projects: Apply learning through interactive exercises and projects
  • Bite-sized lessons: Short, focused lessons for easy learning
  • Lifetime access: Access the course materials for a lifetime
  • Gamification: Engaging learning experience with gamification elements
  • Progress tracking: Track your progress and stay motivated


Who Should Attend

  • Pharmaceutical packaging materials manufacturers
  • Quality managers and assurance professionals
  • Audit and compliance professionals
  • Regulatory affairs professionals
  • Anyone interested in implementing ISO 15378
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