Job Description (JD)
| Nama Program | KAWALAN OPERASI PENGELUARAN ALAT PERUBATAN [C210-001-4:2017] |
|---|---|
| Kod CU | C210-001-4:2017-C03 |
| Competency | Core |
| Tajuk CU | MEDICAL DEVICES PRODUCTION REGULATORY BODIES REQUIREMENTS COMPLIANCE MANAGEMENT |
| Penerangan CU | Regulatory Bodies Requirements Compliance Management describes the competency in coordinating related activities in order to fulfil the requirements of related regulatory bodies on facility and products in accordance with Medical Device Act (Act 737) 2012 and related quality standard. A competent person in this CU shall be able to perform facility certification and product registration. The outcome of this competency is the ability to ensure that manufacturing facility and product are in compliance with related act and regulations. |
| Tempoh Latihan | 240 |
| Objektif Pembelajaran | The person who is competent in this CU shall be able to ensure that manufacturing facility and product are in compliance with related act and regulations. Upon completion of this competency units, trainees will be able to:- 1. Perform facility certification 2. Perform local registration for product 3. Perform international registration for product |
| Pra-Syarat | 0 |