ISO 15378:2017 Internal Auditor Training Program on Primary Packaging Materials for Medicinal Products

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:

• Day 1
  • ISO 15378:2017 Requirements
  • Overview of Primary Packaging Materials for Medicinal Products
  • Introduction to ISO 15378:2017
  • Understanding of new structure, terminology and concepts
  • Quality Concepts & Process Approach
  • Quality Management principles
  • Quality Management System requirements based on ISO 9001:2015
  • Application of Good Manufacturing Practices (GMP)
  • GMP requirements for Printed Primary packaging materials
  • Updates in ISO 15378:2017
  • Adoption of High-Level Structure (HLS)
  • Key differences between ISO 15378:2015 and ISO 15378:2017
  • Documentation requirements
  • Transition guidelines
  Day 2
  • Auditing Concepts and Principles
  • Roles and responsibility of Auditors
  • Planning an Internal Audit
    • Audit plan and Checklists
    • Communication factors
  • Conducting an Audit
    • Opening meeting
    • Collecting objective/audit evidence
    • Effective interviewing techniques
    • Identifying and recording nonconformities
  • Reporting Audit Results
    • Conducting the closing meeting
    • Preparing and distributing the audit report
  • Corrective Actions and Follow ups
    • Corrective and Preventive actions
    • Follow up scheduling
    • Monitoring corrective actions
  Note: Classroom exercises, case studies, role plays and assignments will be spread across all 2 days. Attendance for all 2 days is compulsory for certification. Defaulters will be disqualified.

ISO 15378:2017 – PPM for Medicinal Products - 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.

This course is structured to provide an understanding of ISO 9001 requirements, knowledge and skills required to assess the Quality Management System of an organization blended with case studies, role plays and exercises.

The caliber 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 assist the participants to understand the role of an auditor and equip them with the knowledge and expertise to perform effective internal audits.

• Knowledge and understanding of High-Level Structure based on ISO 9001:2015.
• Application of Good Manufacturing Practice (GMP)
• Audit planning and conduct of audits using the process and techniques
• Identification of non-conformances and subsequent actions

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.

• Participants who pass the written examination will be issued a TÜV SÜD Academy US internal auditor certificate. Unsuccessful candidates will be issued a certificate of attendance.

• Preferred to have basic knowledge of ISO 9001 & GMP Requirements and / or experience in pharmaceutical operations.