Finesse Consults Ltd’s Online ISO 14155 Auditor Training Course is designed to provide you formal training and certification to become a certified ISO 14155 internal auditor. The participants of this course will receive an ISO 14155 Internal Auditor certificate. In this online Internal Auditor training, participants will learn in detail all the requirements of the ISO 14155:2020 international standard. This online ISO 14155 Internal Auditor Training course also provides a complete overview and awareness of the ISO 14155:2020 standard and the benefits of implementation and certification. Our ISO 14155 Auditor Training – E-learning course is beneficial especially for those who prefer to learn auditing processes and techniques from their home or office at their own convenient time and get certified as an ISO 14155 Internal Auditor. This ISO Auditor Training comprising online lectures with audio-visual presentations, handouts, ISO 14155 audit checklist, and online exams will be quite beneficial for all those who want to qualify as a certified Internal Auditor for ISO 14155 audits of medical device manufacturing organizations, healthcare organizations, or research organizations conducting clinical investigations of medical devices for human subjects in any part of the world. After completion of this online course successfully, participants will be awarded an ISO 14155 Internal Auditor certificate as a trained internal auditor.
TOPICS COVERED: ISO 14155 INTERNAL AUDITOR ONLINE COURSE
Finesse Consults Ltd’s online ISO 14155 Auditor training course comprises the following seven sessions:
Session – 1: Overview and Awareness of ISO 14155:2020
Session – 2: ISO 14155: 2020 Clause Wise Requirements
Session – 3: ISO 14155: 2020 Documents and Records
Session – 4: Risk Management
Session – 5: Internal Audit Process
Session – 6: ISO 14155 Internal Audit Records
Session – 7: Steps for ISO 14155: 2020 Installation and Certification
Each of the above sessions consists of modules such as lecture videos, handouts, and online session exams as well as a final exam at the end of all sessions, as described below:
Lectures: In this module, the user gets a video presentation with explanatory audio on each of the above-mentioned seven topics to understand the subject well.
Handouts: For all the above seven sessions, the handouts are given in approximately 125 pages in PDF format. Participants of this ISO 14155 auditor training course can download and save the handouts on their computer for future reference. Also, they can print them or read them offline to get detailed knowledge of all the topics.
Exams: In this Internal Auditor Training course, a total of seven session exams and one final exam are given. After passing the final exam, the auto-generated ISO 14155 Internal Auditor Certificate can be downloaded from our dashboard and printed by participants. This certificate can be verified by anyone anytime from this website.
Audit Checklist: A complete set of more than 150 ISO 14155 clause-wise audit questions are given as a ready tool to perform internal audits based on ISO 14155: 2020 requirements. Participants can download this checklist for future reference and use it during internal ISO 14155 system audits in any clinical investigation organization for medical devices.
COURSE OBJECTIVES
- Familiarize with ISO 14155:2020 standard
- Know the benefits of implementation of this standard and ISO 14155 certification
- Know about the ISO 14155:2020 good clinical practice
- Understand the documents and records required by ISO 14155:2020.
- Understand the process of risk management to prevent risks and accidents in clinical investigations of medical devices in human subjects
- Know the audit process for the ISO 14155:2020 management system
- Know about questioning techniques.
- Know how to prepare internal audit records, including audit plans and nonconformity reports (NCR).
- Get a ready-to-use ISO 14155 audit checklist with clause-wise questions to perform an effective audit.
WHO SHOULD ATTEND THIS COURSE?
This course is for those who want to become a certified ISO 14155 Internal Auditor.
Clinical research professionals
Individuals involved in the implementation of Clinical investigation of medical devices for human subjects — Good clinical practice
Individuals who want to have a basic knowledge of the ISO 14155 standard for working in medical device manufacturing companies or any organizations involved in Clinical investigation of medical devices for human subjects.
Key personnel responsible for the implementation of Good clinical practice within such organizations.
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 trained certified ISO 14155 auditors.
PREREQUISITES
Though there is no prerequisite for enrolling in this online course, having the following will be advantageous for the participants:
- Basic knowledge and interest in Clinical investigation of medical devices for human subjects.
- Having read about the ISO 14155:2020 international standard
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.
STUDY MATERIALS
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 on your computer for future reference. The access to this study material is removed after the exam is cleared and the online certificate is prepared for the student.
EXAMINATION AND COURSE CERTIFICATE
All paid E-learning courses include the Course Certificate that is issued upon course completion and passing the session exams as well as a final exam given in the course with a minimum 60% marks. The option to reappear in the exam is also given to the student, if they fail in any exam.
END OF COURSE INSTRUCTION
After completing the session and passing each session examination, the student can appear for the final exam. Once the final exam is cleared, then it is considered an end of course. The training certificate is ready on our LMS and students can print it or save the training certificate. It is also available for verification by entering the name and certificate number.
