HSA GDPMDS SS 620:2016 Good Distribution Practice for Medical Devices Internal Auditor Training

ABOUT THE COURSE

The SS620:2016 Good Distribution Practice for Medical Devices Internal Auditor training course will introduce participants to the SS 620 Singapore standard, the requirements and expectations of a quality management system required to ensure that the medical device integrity is maintained. This SS 620 course is relevant for anyone or organisation which intends to do distribution activities including the storage of medical devices in Singapore.

Duration: 2 - day course
Language: English

WHAT WILL YOU LEARN FROM THE COURSE?

At the end of the course, participants will be able to appreciate the intent, objectives of HSA GDPMDS SS620: 2016 Quality Management System (QMS) its application and what is the purpose of an internal audit & what it brings about to an organisation.

Topics to be covered in this course include:

• Medical Device Definition and Categories 
• Brief description of risks with regards to Medical Devices application
• Scope, objectives and application of HSA GPMPMDS SS620: 2016 Standard 
• Terms and Definitions associated with Medical Devices
• Storage Handling requirements associated with Medical Devices
• Documentation (SMF, Procedures and Records) requirements - Clause 4.0
• Management Responsibility (Roles and Responsibilities)– Clause 5.0
• Resource Management (People Competency) – Clause 6.0
• Premises and Facilities – (Medical devices activities) Clause 7.0
• Secondary Assembly (Re-packing and relabeling)– Clause 8.0
• Traceability (Stock Inventory and Control and Transaction)– Clause 9.0
• Counterfeit, Adulterated, Unwholesome or Tampered Medical Devices (Integrity of medical devices) – Clause 10.0
• Complaint Handling (Application issues）- Clause 11.0
• Field Safety Corrective Action (FSCA) (Potential user safety issues) – Clause 12.0
• Internal Audit – Clause 13.0
• HSA Guidance Documents 
• Outsourced Activities (Scope and activities)– Clause 14.0
• Audit Fundamental (Differences between External and Internal)
• Terms and Definitions
• Internal Auditing Scope, Plan, Method and Reporting
• Nonconformity Management

WHAT IS THE COURSE METHODOLOGY?

Participants will learn through lectures, case studies, group exercises and discussions.

WHO SHOULD TAKE THE COURSE?

This course is specially designed for:

• Anyone who is interested or would like to conduct distribution activities of medical devices

Prerequisite: None

WHO IS THE COURSE ADVISOR?

The course content and structure are designed by the domain experts from TÜV SÜD.

With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.