- ISO 13485 :2016 standard review
- Understand ISO 13485:2016 Medical Device Quality Management System audit and regulatory requirements
- Internal auditing (including audit planning, auditing methodology, auditing skills, reporting and CAPA follow up
- To understand the application of Medical Device Quality Management System.
- To understand the importance of internal auditing and the responsibilities of internal auditors
- To plan and organize an internal audit
WHO SHOULD ATTEND?
- Person in charge of establishing and implementing ISO 13485:2016
- Management Representatives
- Person wishes be trained as ISO 13485:2016 internal auditors
- Person is seeking for learning essential knowledge in quality management control in medical device industry
- Medical Device professionals interested in conducting first party, second party, and/or third party audits
CERTIFCATE AND CPD:
Certificate of successful Completion will be awarded delegates who have attended full course. An e-Certificate will only be granted. You may be able to claim CPD hours for your membership at professional bodies.
** RTTP (Reindustrialisation and Technology Training Progamme) Recognized Training Course **
RTTP Pre-approval training courses, eligible company could apply for RTTP funding in order to receive up to 2/3 course fee reimbursement for each employee.