In the pharmaceuticals and medical device industries, ISO 15378:2017 certification serves the purpose of ensuring the quality of primary packaging materials for medicinal products. The web-based Certified ISO 15378 auditor training – online course is designed to offer online training and certification for individuals aspiring to become internal auditors for the ISO 15378:2017 Quality Management System. In this latest ISO 15378 training online course, participants will acquire comprehensive knowledge about ISO 15378:2017 requirements and how to conduct an effective internal audit within their organizations. Upon successful completion of this ISO 15378 auditor online training course, participants will gain understanding in quality management system audits, ISO 15378:2017 internal audit records, and receive an auto-generated ISO 15378 Certified Auditor Training Certificate online as a certified ISO 15378 internal auditor.
TOPICS COVERED: ISO 15378 INTERNAL AUDITOR TRAINING ONLINE
This newly introduced ISO 15378 internal auditor training consists of 7 interactive online sessions, combining lectures with audio-visual presentations, handouts, recorded training videos, and online exams to ensure a comprehensive understanding of the subject.
- Session – 1: Overview of ISO 15378:2017
- Session – 2: ISO 15378:2017 requirements
- Session – 3: ISO 15378:2017 Documented Information
- Session – 4: ISO 15378:2017 Internal Management system audit
- Session – 5: ISO 15378:2017 Internal audit records
- Session – 6: Risk Management
- Session – 7: Steps for ISO 15378:2017 Installation and Certification
Lectures: There are 7 lectures in the online sessions, presented as audio-visual presentations to facilitate understanding.
Handouts: For all 7 online sessions, handouts totaling over 156 pages are provided in PDF format. Course participants can download, save, print, or read these handouts offline to gain in-depth knowledge of the seven topics.
Video Tutorials: Key sessions such as documentation, requirements, audit, and risk are supplemented with online video tutorials. Approximately 2 hours of video tutorials provide in-depth knowledge of key auditor requirements.
Exams: In this ISO 15378 internal auditor training course, participants must pass all 7 session exams and one final exam provided in a separate course section. Upon successfully passing the final exam, an auto-generated ISO 15378 Auditor Training Certificate can be downloaded and printed from the dashboard.
Audit Checklists: The ISO 15378 Audit checklist offers a complete set of over 350 audit questions in line with ISO 15378:2017 standard requirements and department-wise criteria. The ISO 15378:2017 audit checklist aids participants in preparing for the final audit.
COURSE OBJECTIVES
Upon completing this ISO 15378 auditor training e-learning course, users will be able to:
- Familiarize themselves with ISO 15378 requirements in detail
- Understand resource and process requirements
- Comprehend the documentation needed by ISO 15378
- Understand documentation and the list of procedures to be maintained, as well as check them as an internal auditor
- Acquire knowledge of internal auditing and the use of an audit checklist
- Learn about various auditing types and questioning techniques
- Familiarize themselves with the implementation of ISO 15378 Certified Auditor programs in detail
- Access a ready-to-use audit checklist with clause-wise questions to conduct an effective audit
WHO SHOULD ATTEND THIS COURSE?
This course is suitable for:
- Individuals aspiring to become ISO 15378 Internal Auditors
- Individuals involved in implementing management systems within their organizations
- Individuals with basic knowledge of the standard or working within an organization
- Key personnel involved in implementation within their organizations
- Others seeking to enhance their auditing knowledge and skills, and those looking to gain formal recognition as certified ISO 15378 trained auditors
PREREQUISITES FOR ENROLLING IN ISO 15378 CERTIFIED AUDITOR COURSE
Applicants should have:
- Knowledge of Management systems and familiarity with the standard
- Understanding of the Plan-Do-Check-Act (PDCA) cycle
- Knowledge of Good Manufacturing Practice (GMP) principles and concepts
AUTHORS & INSTRUCTORS
Details about the authors, trainers, and instructors’ experience and background can be found on our trainers page. They possess extensive expertise in the subject.
STUDY MATERIALS
This e-Learning course comes with study materials that you can access upon logging in or download in PDF format. Utilize these materials to reinforce key points, serve as reminders of what you’ve learned, and save for future reference. Access to study materials is revoked after the exam is cleared, and the online certificate is prepared for the student.
EXAMINATION AND COURSE CERTIFICATE
All paid e-learning courses include a Course Certificate issued upon course completion and passing the session exams, along with the final exam with a minimum score of 60%. Students failing an exam are provided the option to retake it.
END OF COURSE INSTRUCTION
Upon completing the sessions and passing each session examination, students can take the final exam. Successful completion of the final exam marks the conclusion of the course. The training certificate is available on our Learning Management System (LMS) for printing or saving and can be verified using the name and certificate number.
