Job Description (JD)
Nama Program | KAWALAN OPERASI PENGELUARAN ALAT PERUBATAN [C210-001-4:2017] |
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Kod CU | C210-001-4:2017-C08 |
Competency | Core |
Tajuk CU | MEDICAL DEVICES MANUFACTURING QUALITY MANAGEMENT SYSTEM COMPLIANCE |
Penerangan CU | Manufacturing Quality Management System Compliance describes the competency in planning, auditing and fulfilling manufacturing QMS requirements in compliance with client and related regulatory bodies requirements. A competent person in this CU shall be able to plan manufacturing QMS requirements compliance, assess manufacturing QMS documentations and report manufacturing QMS activities. The outcome of this competency is to ensure compliance of manufacturing QMS in order to produce biocompatible and biosafety medical device products. |
Tempoh Latihan | 300 |
Objektif Pembelajaran | The person who is competent in this CU shall be able to ensure compliance of manufacturing QMS in order to produce biocompatible and biosafety medical device products. Upon completion of this competency units, trainees will be able to:- 1. Plan manufacturing QMS requirements compliance 2. Assess manufacturing QMS documentations 3. Report manufacturing QMS activities |
Pra-Syarat | 0 |