ISO 14155 Internal Auditor Training

PAS970: ISO 14155 Certified Internal Auditor Training E-learning Course Duration: 16 Hours (02 Days)

Website: www.Punyamacademy.com Chapter - 1: CONTENTS OF ISO 14155 CERTIFIED INTERNAL AUDITOR TRAINING E-LEARNING COURSE Sr. No.

The entire e-learning course has 5 main parts as below Lectures/Videos

1.

Details No. of Videos

1. Session - 1: Overview and Awareness of ISO 14155:2020

01

2. Session - 2: ISO 14155: 2020 Clause Wise Requirements

03

3. Session - 3: ISO 14155: 2020 Documents and Records

01

4. Session - 4: Risk Management

01

5. Session - 5: Internal Audit Process

01

6. Session - 6: ISO 14155 Internal Audit Records

01

7. Session - 7: Steps for ISO 14155: 2020 Installation and Certification

01

Total no. of Lectures/Videos (with Audio lectures) ➔ 2.

Hand-outs (each session detail document is given in PDF and participant can download, print, or save it for future reference)

3.

Session Exams at end of each session and Final Exam

4.

Audit Checklist as per Department-wise and Clause-wise

5.

SA 8000 and ISO 26000 Internal Auditor Training Certificate

09 Approx. 125 Pages in PDF Total 8 Exams More than 150 audit questions Award certificate

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PAS970: ISO 14155 Certified Internal Auditor Training E-learning Course Duration: 16 Hours (02 Days)

Website: www.Punyamacademy.com Part – 1 Lectures/Videos: 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.

Sr. No 1 2 3 4 5 6 7

Name of Videos 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

No. of Videos 01 Videos 03 Videos 01 Videos 01 Videos 01 Videos 01 Videos 01 Videos

Part – 2 Hand-outs: For all the above seven sessions, the handouts are given in approximately 125 pages in pdf format. The participants of this ISO 14155 auditor training course can download and save the handouts in their computer for future reference. Also, they can print them or read them offline to get detailed knowledge of all the topics.

Part – 3 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.

Part – 4 Audit Checklists: A complete set of more than 150 ISO 14155 clause wise audit questions are given as a ready tool to perform internal audit based on ISO 14155: 2020 requirements. Participants can download this checklist for future reference and use it during the internal ISO 14155 system audit in any clinical investigation organization for medical devices.

Part – 5 Training Certificate: After passing the exam the colorful training certificate is generated and user can download it or print it. Any one globally can cross verify the training certificate through our LMS platform.

For more information about ISO 14155 Internal Auditor Training Click Here www.punyamacademy.com E mail: sales@punyamacademy.com Tele: +91-79-2979 5322

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PAS970: ISO 14155 Certified Internal Auditor Training E-learning Course Duration: 16 Hours (02 Days)

Website: www.Punyamacademy.com Chapter - 2: COURSE OBJECTIVES After completion of this ISO 14155 Internal Auditor Training - Online Course, you will be able to: ✓ 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 risk and accidents in clinical investigations of medical devices in human subjects. ✓ Know the audit process for ISO 14155:2020 management system. ✓ Know about the questioning techniques. ✓ Know how to prepare internal audit records, including audit plan and nonconformity report (NCR). ✓ Get a ready-to-use ISO 14155 audit checklist with clause-wise questions to perform an effective audit.

Chapter - 3: WHO SHOULD ATTEND THIS COURSE? ➢ Individuals who want to become a certified ISO 14155 Internal Auditor. ➢ Clinical research professionals. ➢ Individuals involved in the implementation for Clinical investigation of medical devices for human subjects — Good clinical practice. ➢ Individuals who want to have a basic knowledge of 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 auditor.

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PAS970: ISO 14155 Certified Internal Auditor Training E-learning Course Duration: 16 Hours (02 Days)

Website: www.Punyamacademy.com Chapter - 4: USER MANUAL Compatibility and Requirements for smoothly running our course 1. Bandwidth: Internet bandwidth must me 1 MBPS or higher.

2. Operating System: Microsoft Windows XP and higher versions, iOS, Android.

3. Browser: Best viewable in Mozilla Firefox, Google Chrome. Also supports Internet Explorer.

4. Screen Resolution: To view slides properly, you must have a screen resolution of 1024 x 768 or higher.

5. Cookies: You must have browser cookies enabled, so that we can maintain your current session as you navigate through the application.

6. JavaScript: You must have enabled JavaScript, so that application runs smoothly.

7. Adobe Acrobat Reader: Some documents in our application are in .pdf format, so you must have installed adobe acrobat reader in your computer to be able to read such documents that you download.

8. Pop-up Enable: In your browser setting, check Pop-up blocker off, or enable Pop-up window.

9. Speaker: You must have speakers or a headphone attached to your computer, so that you can listen to the course lecture while learning.

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PAS970: ISO 14155 Certified Internal Auditor Training E-learning Course Duration: 16 Hours (02 Days)

Website: www.Punyamacademy.com Chapter - 5: ABOUT COMPANY Punyam Academy is registered and certified under a scheme of Personnel Certification as per ISO/IEC 17024, which offers various ISO Training Courses and conducts webinars for online certification as well as classroom training. We are a leading name in E-learning, training and certification on ISO standards and all other types of management system standards. Punyam Academy specializes in a complete range of courses on awareness, auditor and lead auditor courses on ISO 9001, ISO 14001, ISO 45001, ISO 22000, ISO 27001, OHSAS 18001, ISO/IEC 17025, ISO/IEC 17020, ISO/IEC 17021, FSSC 22000, ISO 27001, ISO 50001, ISO 13485, ISO 20000, ISO/IEC 17024, ISO 17034, Sedex, ISO 22301, NABH, Certified Calibration Engineer and other management system training courses. We provide E-learning courses on all of these topics through effective, enjoyable and time-saving online training sessions and webinars. We have conducted more than 300 public training programs as well as online corporate training sessions in more than 45 countries.

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