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.
- 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
- 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
- Adoption of High Level Structure (HLS)
- Key differences between ISO 15378:2015 and ISO 15378:2017
- Documentation requirements.
- Transition guidelines
- Auditing Concepts and Principles
- Roles and responsibility of Auditors
- Planning an Internal Audit
- Audit plan and Checklists
- 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 both days. Attendance for both 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.
Participants are preferred to have basic knowledge of ISO 9001 and GMP Requirements and / or experience in pharmaceutical operations.
Participants will be assessed through a 60 marks written examination (open book) at the end of the course. Minimum passing % criteria: 70%.
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.