Training requirements

培训要求

Training on a regular basis (at least annually)

定期培训（至少每年一次）

Basic knowledge and skills: training needs and frequency depending on  main tasks and responsibilities (at least once)

基础知识和技能：根据主要任务和职责的培训需求和频率（至少一次）

Applicable  international GMP guidance and legislation

适用的国际GMP指南和法规

X

Applicable  national GMP guidance and legislation

适用的国家GMP指南和法规

X

General and  specific GMP requirements

一般和特定的GMP要求

X

Marketing and  manufacturing authorisation systems and their relationship/ regulatory  affaires

上市和生产许可系统及其关系/监管事务

x

Microbiology

微生物学

x

Process  engineering/ HVAC
 Systems

工艺工程/空调系统

x

Utilities

公用系统

x

Analytical  equipment and instrumentation

分析设备和仪器

x
 (see also 5.2)

Analytical  methods and validation

分析方法和验证

x

Computer systems  and validation

计算机系统和验证

x

(New)  Pharmaceutical technologies and production

（新）制药技术和生产

x
 (see also 5.2)

Manufacturing,  quality control, release and distribution of IMPs

IMP（临床试验用药）的制造、质量控制、放行和分销

x

API: technology,  equipment, processes

原料药：技术、设备、工艺

x

Process  validation

工艺验证

x

Instrument and  equipment qualification, calibration, maintenance

仪器设备确认、校准、维护

x

Storage and  distribution

储存和运输

x

Pharmacovigilance

药物警戒

x

Import and  export of medicinal products

医药产品进出口

x

Complaint  handling and recalls

投诉处理和召回

x

OOS/ Deviation  handling and failure investigation

OOS/偏差处理和失败调查

x

Change  Management/ Change Control

变更管理/变更控制

x

Risk analysis  and risk management

风险分析和风险管理

x

Stability  testing

稳定性测试

x

Good  documentation practice and review

良好文件记录规范和审核

x

Serialization

序列化

x

Product Quality  Review

产品质量回顾

x

Data Integrity/  Data Governance

数据完整性/数据治理

Auditing  techniques

审计技术

x

Inspection  preparation

检查准备

x

Communication  skills, time and conflict management

沟通技巧、时间和冲突管理

x