0084-iso-15387-2017-internal-auditor-training-program

Internal Auditor Training Program on Primary Packaging Materials for Medicinal Products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) based on ISO 15378:2017

Face-to-face Training02 DaysIntermediate
  • 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

V A Shyamala Course Counsellor

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.

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
    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

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.

  • 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.


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

1. When can I get the certificate?

Internal Auditor Training Program on Primary Packaging Materials for Medicinal Products certification will be issued within 21 working days from the examination date.

2. When can I get the training material and invite?

One day before the commencement of the training program.

3. How do I pay the fees for training and examination?

Online mode

4. What are the benefits of the Internal Auditor Training Program on Primary Packaging Materials for Medicinal Products?

  • 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

5. Is there any refund policy for the paid fees?

Please refer to Cancellation and Refund policy page.

Net Price (excl. GST)
₹ 15,000.00
infoWe accept major credit cards, debit cards and UPI. EMI options are also available from major banks*


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