Job Description (JD)
| Nama Program | KAWALAN OPERASI PENGELUARAN ALAT PERUBATAN [C210-001-4:2017] |
|---|---|
| Kod CU | C210-001-4:2017-C07 |
| Competency | Core |
| Tajuk CU | MEDICAL DEVICES PRODUCTION STANDARD OPERATING PROCEDURES DEVELOPMENT & COMPLIANCE |
| Penerangan CU | Standard Operating Procedures Development & Compliance describes the competency in preparing and producing policies, procedures, guidelines and forms to ensure that establishment’s documents are consistent, clear and well communicated. A competent person in this CU shall be able to assess SOP review and development requirements, prepare SOP documentation, manage SOP development and manage SOP revision. The outcome of this competency is to develop, revise and maintain comprehensive SOP for operational needs in accordance with International Organisation for Standardisation (ISO), and relevant regulatory bodies requirements. |
| Tempoh Latihan | 180 |
| Objektif Pembelajaran | The person who is competent in this CU shall be able to develop, revise and maintain comprehensive SOP for operational needs in accordance with International Organisation for Standardisation (ISO), and relevant regulatory bodies’ requirements. Upon completion of this competency units, trainees will be able to:- 1. Assess SOP review and development requirements 2. Prepare SOP documentation 3. Manage SOP development 4. Manage SOP revision |
| Pra-Syarat | 0 |