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. For more information about ISO 14155 Internal Auditor Training Click Here www.punyamacademy.com E mail: sales@punyamacademy.com Tele: +91-79-2979 5322
Page 3 of 5
