ISO 15378:2017 Internal Auditor Training Program

WHAT IS ISO 15378:2017

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

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. 

YOUR BENEFITS

• 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

COURSE CONTENT / OUTLINE

Day 1

• ISO 15378:2017 Requirements
• Overview of 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 concepts and process approach
• Quality Management System requirements based on 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 guidelines

Day 2

• Auditing Concepts and Principles
• Roles and responsibility of Auditors
• Planning an Internal Audit
  o Audit plan and Checklists
  o Communication factors.
• Conducting an Audit
  o Opening meeting
  o Collecting objective/audit evidence
  o Effective interviewing 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 ups
  o Corrective and Preventive actions
  o Follow up scheduling
  o Monitoring corrective actions.

• Examination

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.

WHO SHOULD ATTEND?

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

TRAINING DURATION

2 Days

PREREQUISITES

Preferred to have basic knowledge of ISO 9001 & GMP Requirements and / or experince in Pharmaceutical operations.

PARTNER INSTITUTE INFO (IF ANY)

Nil

EXAM DETAILS (DURATION, PATTERN)

Participants will be assessed through a 60 marks written examination (open book) at the end of the course. Minimum passing % criteria: 70%.

CERTIFICATION

Participants who score 70% and above in the written examination will be issued a TÜV SÜD South Asia’s internal auditor certificate. Unsuccessful candidates will be issued a certificate of attendance.