Internal auditor training program based on ISO 15378:2017 Standard (Primary Packaging Material (PPM) for Medicinal Products)
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.
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.
Preferred to have basic knowledge of ISO 9001 & GMP Requirements and / or experince 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.
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Bosnia and Herzegovina