SS 620:2016 Good Distribution Practice for Medical Devices Internal Auditor
With this interactive training program, you will:
- Receive a recognised certificate demonstrating your proficiency in conducting internal audits based on SS 620:2016 Good Distribution Practice for Medical Devices (GDPMDS) requirements.
- Gain in-depth knowledge of the SS 620:2016 standard, focusing on quality management systems specific to the distribution of medical devices in Singapore.
- Develop practical skills to plan, conduct, and report on internal audits of GDPMDS, ensuring compliance with regulatory requirements and maintaining medical device integrity throughout the distribution chain.
- Learn to identify and assess potential risks in the medical device distribution process, enhancing your ability to evaluate the effectiveness of quality controls and procedures.
- Acquire techniques for gathering objective evidence, conducting interviews, and documenting audit findings in accordance with SS 620:2016 guidelines.
- Network with professionals from the medical device industry, sharing experiences and building relationships with peers facing similar quality management challenges.
- Enhance your professional qualifications and broaden your career prospects in the fields of medical device quality assurance, regulatory compliance, and distribution management.
- Prepare yourself to contribute significantly to your organisation's efforts in achieving and maintaining compliance with SS 620:2016, ensuring the safe and effective distribution of medical devices in Singapore
At the end of the course, you will:
- 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.
In this program, you will learn the following:
- 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 relabelling)– 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
The course is specially designed for:
- Anyone who is interested or would like to conduct distribution activities of medical devices
The career prospects for the SS 620:2016 Good Distribution Practice for Medical Devices Internal Auditor Training Programme are excellent. As the medical device industry places greater emphasis on maintaining high standards of distribution practices, there is a growing demand for professionals skilled in conducting internal audits based on SS 620:2016 standards.
Career prospects include:
- Internal Auditor for Good Distribution Practice (GDP)
- Quality Assurance Manager
- Regulatory Compliance Specialist
- Medical Device Distribution Consultant
- Compliance Officer
- Logistics and Distribution Manager
- GDP Trainer and Educator
The course content and structure are developed by the domain experts from TÜV SÜD. With immense experience and knowledge of the relevant standards, our team of product specialists and technical experts at TÜV SÜD have developed the course content based on the current business landscape and market requirements.
Upon completing the course, you will receive a certificate from TÜV SÜD.
1. Can I also attend e-learning courses on top of attending the SS 620:2016 Good Distribution Practice for Medical Devices Internal Auditor course?
Yes, you can register for any e-learning course at TÜV SÜD.
2. How do I enroll for the SS 620:2016 Good Distribution Practice for Medical Devices Internal Auditor course?
To enroll, please click on "Buy now" and check out your cart.
3. What is the SS 620:2016 Good Distribution Practice for Medical Devices Internal Auditor methodology?
Participants will learn through lectures, case studies, group exercises and discussions.
4. Can I get a refund if I cancel my enrolment?
- If you communicate the cancellation to us by email within 14 days before the confirmed training date, we will not provide a refund for the training.
- If you communicate the cancellation to us by email more than 14 days before the confirmed training date, we will provide a 50 % refund for the training.
5. Are there any tests in the middle of the course?
There are no in-between assessments, but case studies will be included in the SS 620:2016 Good Distribution Practice for Medical Devices Internal Auditor course.