In pharmaceuticals and medical device industries, The ISO 15378:2017 certification purposes of primary packaging material for medicinal products. The web-based Certified ISO 15378 auditor training - online course is designed to provide online training and certification to become an internal auditor for ISO 15378:2017 Quality Management System. In this latest ISO 15378 training online course, you will learn everything you need to know about ISO 15378:2017 requirements and also how to perform an effective internal audit in your company. After successful completion of this ISO 15378 auditor online training course, the participants will gain knowledge and understanding of the quality management system audit, ISO 15378:2017 Internal audit records and get auto-generated ISO 15378 Certified Auditor Training Certificate online for trained ISO 15378 internal auditor.
TOPICS COVERED: ISO 15378 INTERNAL AUDITOR TRAINING ONLINE
This Newly ISO 15378 internal auditor training includes a total of 07 interactive online sessions with combinations of lectures with audio-visual presentation and handouts as well as recorded training videos and online exams to ensure a complete understanding of this 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
Each of the above sessions consists of modules such as Audio lectures, hand-outs and session exams as well as one final exam as below:
There are 7 lectures of online sessions, which are given in this course as a presentation with explanatory audio and visuals to understand the subject well.
For all the above 7 online sessions, the hand-outs are given in more than a total of 156 pages in pdf format. The users of this course can download and save the handouts to their computer and print them or read them offline to get detailed knowledge of all the seven topics mentioned above.
- Video Tutorials:
For some key sessions like documentation, requirements, audit, risk, etc. online video tutorials are given. A total of Approx. 2 hours of video tutorials help users to get detailed knowledge of all the key requirements that auditors must have known.
In this ISO 15378 internal auditor training course, the participant has to clear all 07 session's exams and one final exam as given in a separate section of the course. After successfully passing the final exam, an auto-generated ISO 15378 Auditor Training Certificate will be issued and can be downloaded and printed from the dashboard.
- Audit Checklists:
The ISO 15378 Audit checklist - complete set of more than 350 audit questions as per ISO 15378:2017 standard requirement-wise as well as department-wise. The ISO 15378:2017 audit checklist also helps participants to prepare for the final audit.
After completion of this ISO 15378 auditor training e-learning course, the user will be able to:
- Familiarize yourself with ISO 15378 Requirements in detail.
- Know about the resource requirements and process requirements.
- Understand the documentation required by ISO 15378
- Understand documentation and list of procedures to be maintained, and to check them as an internal auditor.
- Get the knowledge of internal auditing and use of audit checklist.
- Know about the types of auditing and questioning techniques.
- Familiarize yourself with the implementation of ISO 15378 Certified Auditor programs in detail.
- Get the ready-to-use audit checklist with clause-wise questions to perform an effective audit.
WHO SHOULD ATTEND THIS COURSE?
- Individuals who want to become ISO 15378 Internal Auditor
- Individuals involved in the implementation of the management system within the organization.
- Individuals having a basic knowledge of standard or working in the organization
- Key personnel in the implementation within the organization
- Other people who have found this course useful and who want to enhance their auditing knowledge and skills, and those looking to achieve formal recognition as certified ISO 15378 trained auditor.
Prerequisites for Enrol ISO 15378 Certified Auditor Course
- Knowledge of Management systems and read the standard
- Understand the Plan-Do-Check-Act (PDCA) cycle.
- Knowledge of the GMP principles and concepts.
AUTHORS & INSTRUCTORS
For details of the authors, trainers and instructors experience and background, please visit our trainers page. They have very rich experience on the subject.
This e-Learning course is provided with study materials and you can read it after your log in or download (PDF format). Use the study materials to reinforce key points and to keep a reminder of what you already learned as well as you can save it in your computer for future reference. The access of this study material is removed after exam is cleared and on line certificate is prepared for the student.
EXAMINATION AND COURSE CERTIFICATE
This training program includes the Course Certificate that is issued upon course completion and passing the session exam as well as final exam given in the course with minimum 60% marks. The option to reappear in the exam is also given to student to get this course certificate
END OF COURSE INSTRUCTION
After completing the session and passing each session examination the student can appear for final exam. Once the final exam is cleared then it is considered a end of course. The training certificate is ready on our LMS and student can print it or save the training certificate. It is also available for verification by entering the name and certificate number.