ISO 13485:2016 Medical Devices Quality Management System-Internal Auditor

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. 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

Details
Course Code: TMD4
Duration: 2 days
Venue: ACI Training Venue
Language: Cantonese supplemented with English material
Methodology: Presentation, workgroups discussion and exercise
Price: $3,800
Schedule
Date:
11 Jun, Thu - 12 Jun, Fri
27 Jul, Mon - 28 Jul, Tue
24 Aug, Mon - 25 Aug, Tue
28 Sep, Mon - 29 Sep, Tue
29 Oct, Thu - 30 Oct, Fri
23 Nov, Mon - 24 Nov, Tue
28 Dec, Mon - 29 Dec, Tue
Course Code: TMD4
Price: HKD3,800
Duration: 2 days