COURSE CONTENT
- 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
OBJECTIVE
- 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.
Coupon:
Available
Enhance Your Expertise with ACI Training Courses + Enjoy a Complimentary Lunch Worth HK$100! with every public paid full day training course
As a gesture of appreciation for your dedication to professional growth, we are delighted to offer a complimentary lunch valued at HK$100 with every public paid training course. This is our way of ensuring that your learning experience is both enriching and enjoyable. To make your experience even more delightful, participants can enjoy a delicious meal at the popular Sushiro Japanese Food Restaurant conveniently located just downstairs from our training venue.
