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Training requirements

培訓(xùn)要求

Training on a regular basis (at least annually)

定期培訓(xùn)（至少每年一次）

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

基礎(chǔ)知識和技能：根據(jù)主要任務(wù)和職責(zé)的培訓(xùn)需求和頻率（至少一次）

Applicable  international GMP guidance and legislation

適用的國際GMP指南和法規(guī)

X

Applicable  national GMP guidance and legislation

適用的國家GMP指南和法規(guī)

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

上市和生產(chǎn)許可系統(tǒng)及其關(guān)系/監(jiān)管事務(wù)

x

Microbiology

微生物學(xué)

x

Process  engineering/ HVAC
 Systems

工藝工程/空調(diào)系統(tǒng)

x

Utilities

公用系統(tǒng)

x

Analytical  equipment and instrumentation

分析設(shè)備和儀器

x
 (see also 5.2)

Analytical  methods and validation

分析方法和驗證

x

Computer systems  and validation

計算機系統(tǒng)和驗證

x

(New)  Pharmaceutical technologies and production

（新）制藥技術(shù)和生產(chǎn)

x
 (see also 5.2)

Manufacturing,  quality control, release and distribution of IMPs

IMP（臨床試驗用藥）的制造、質(zhì)量控制、放行和分銷

x

API: technology,  equipment, processes

原料藥：技術(shù)、設(shè)備、工藝

x

Process  validation

工藝驗證

x

Instrument and  equipment qualification, calibration, maintenance

儀器設(shè)備確認(rèn)、校準(zhǔn)、維護

x

Storage and  distribution

儲存和運輸

x

Pharmacovigilance

藥物警戒

x

Import and  export of medicinal products

醫(yī)藥產(chǎn)品進出口

x

Complaint  handling and recalls

投訴處理和召回

x

OOS/ Deviation  handling and failure investigation

OOS/偏差處理和失敗調(diào)查

x

Change  Management/ Change Control

變更管理/變更控制

x

Risk analysis  and risk management

風(fēng)險分析和風(fēng)險管理

x

Stability  testing

穩(wěn)定性測試

x

Good  documentation practice and review

良好文件記錄規(guī)范和審核

x

Serialization

序列化

x

Product Quality  Review

產(chǎn)品質(zhì)量回顧

x

Data Integrity/  Data Governance

數(shù)據(jù)完整性/數(shù)據(jù)治理

Auditing  techniques

審計技術(shù)

x

Inspection  preparation

檢查準(zhǔn)備

x

Communication  skills, time and conflict management

溝通技巧、時間和沖突管理

x