ISPE Shanghai

国际制药工程学会(International Society for Pharmaceutical Engineering , 以下简称ISPE)是一个全球化的非营利性行业学会。旨在通过在整个制药生命周期中领导科学、技术和监管的进步,为其成员提供制药专业领域的服务,致力于通过论坛交流学术思想和实践经验,提高其成员的知识水平和技术效率。目前在全球制药工程领域,享有极高的学术权威影响力,多次受邀参加美国食品药品监督管理局(FDA)针对制药工程领域监管法规制定和研讨。
在上海市科学技术委员会的业务指导和支持下,国际制药工程学会(美国)上海代表处开展制药行业的中外学术交流活动,加强ISPE全球制药工程领域同仁与中国制药企业、监管机构、高等院校和研究机构等相关人士的学术交流、探讨与合作,服务中国特别是上海生物医药科技和产业创新,为复杂的制药行业的挑战提供解决方案。

https://www.ispe.cn/

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Event Details

This activity is a guide to buying. More information about the guide can be found on the global website




You can also directly remit to Shanghai company :(please contact the staff in advance and fill in the purchase form)


公司抬头:上海埃思博益医药信息有限公司

账号:1001309909024212471

开户行:中国工商银行股份有限公司上海自贸试验区分行




Note:


1. Due to the epidemic, it may take one month to purchase the guide


2. Please fill in the form in English


3, can be issued general ticket, the content of consulting fees, after buying can contact LMiaoyi@ispe.org issued

Good Practice Guide: Operations Management

Member PriceRMB 790
Standard PriceRMB 1,880

Good Practice Guide: Membrane-Based WFI Systems

Member PriceRMB 1,080
Standard PriceRMB 2,180

Good Practice Guide: Management of Engineering Standards

Member PriceRMB 370
Standard PriceRMB 1,460

Good Practice Guide: Maintenance 2nd Edition

Member PriceRMB 1,080
Standard PriceRMB 2,180

Good Practice Guide: Knowledge Management in the Pharmaceutical Industry

Member PriceRMB 1,080
Standard PriceRMB 2,180

Good Practice Guide: Interactive Response Technology

Member PriceRMB 530
Standard PriceRMB 1,639

Good Practice Guide: IMP Reverse Logistics

Member PriceRMB 1,080
Standard PriceRMB 2,180

Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms

Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms,Just English Version。

Member PriceRMB 785
Standard PriceRMB 1,880

Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms

Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms,Just English Version。

Member PriceRMB 785
Standard PriceRMB 1,880

Good Practice Guide: Harmonizing the Definition and Use of NIMPs

Member PriceRMB 370
Standard PriceRMB 1,460

Good Practice Guide: Good Engineering Practice 2nd Edition

Member PriceRMB 1,080
Standard PriceRMB 2,180

Good Practice Guide: Equipment Reliability

Member PriceRMB 1,080
Standard PriceRMB 2,180

Good Practice Guide: Development of Investigational Therapeutic Biological Products

Member PriceRMB 785
Standard PriceRMB 1,880

Good Practice Guide: Decommissioning Pharma Equipment & Facilities

Member PriceRMB 785
Standard PriceRMB 1,880

Good Practice Guide: Critical Utilities GMP Compliance

Member PriceRMB 1,080
Standard PriceRMB 2,180

Good Practice Guide: Controlled Temperature Chambers 2nd Edition

Member PriceRMB 1,080
Standard PriceRMB 2,180

Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms

Member PriceRMB 1,080
Standard PriceRMB 2,180

Good Practice Guide: Containment for Potent Compounds

Member PriceRMB 1,080
Standard PriceRMB 2,175

Good Practice Guide: Comparator Management

Member PriceRMB 365
Standard PriceRMB 1,460

Good Practice Guide: Cold Chain Management

Member PriceRMB 785
Standard PriceRMB 1,880

Good Practice Guide: Clinical Supply Systems

Member PriceRMB 530
Standard PriceRMB 1,630

Good Practice Guide: C&Q of Pharma Water & Steam Systems 2nd Edition

Member PriceRMB 785
Standard PriceRMB 1,880

Good Practice Guide: Booklet Labels

Member PriceRMB 365
Standard PriceRMB 1,460

Good Practice Guide: Asset Management

Member PriceRMB 785
Standard PriceRMB 1,880

Good Practice Guide: Assessing Particulate Containment 2nd Edition

Member PriceRMB 785
Standard PriceRMB 1,880

GAMP RDI Good Practice Guide: Data Integrity by Design

Member PriceRMB 1,450
Standard PriceRMB 2,540

GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records

Member PriceRMB 920
Standard PriceRMB 2,010

GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

Member PriceRMB 920
Standard PriceRMB 2,010

GAMP Good Practice Guide: Testing GxP Systems 2nd Edition

Member PriceRMB 785
Standard PriceRMB 1,880

GAMP Good Practice Guide: Regulated Mobile Applications

Member PriceRMB 785
Standard PriceRMB 1,880

GAMP Good Practice Guide: Operation of GxP Computerized Systems

Member PriceRMB 785
Standard PriceRMB 1,880

GAMP Good Practice Guide: Manufacturing Execution Systems

Member PriceRMB 785
Standard PriceRMB 1,880

GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition

Member PriceRMB 785
Standard PriceRMB 1,880

GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition

Member PriceRMB 785
Standard PriceRMB 1,880

GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition

Member PriceRMB 785
Standard PriceRMB 1,880

GAMP Good Practice Guide: Global Info Systems Control & Compliance 2nd Edition

Member PriceRMB 785
Standard PriceRMB 1,880

GAMP Good Practice Guide: Enabling Innovation

Member PriceRMB 1,080
Standard PriceRMB 2,175

GAMP Good Practice Guide: Computerized GCP Systems & Data

Member PriceRMB 785
Standard PriceRMB 1,880

GAMP Good Practice Guide: Calibration Management 2nd Edition

Member PriceRMB 785
Standard PriceRMB 1,880

GAMP5 第一版中文版

Member PriceRMB 1,442
Standard PriceRMB 2,537

GAMP 5 Guide 2nd Edition

Member PriceRMB 1,442
Standard PriceRMB 2,537

GAMP Guide: Records & Data Integrity

Member PriceRMB 1,442
Standard PriceRMB 2,537

Good Practice Guide: Ozone Sanitization of Pharma Water Systems

Member PriceRMB 790
Standard PriceRMB 1,880

Good Practice Guide: Packaging, Labeling, & Warehousing Facilities

Member PriceRMB 790
Standard PriceRMB 1,880

Good Practice Guide: Process Gases 2nd Edition

Member PriceRMB 1,100
Standard PriceRMB 2,200

Good Practice Guide: Process Validation English Version

Member PriceRMB 790
Standard PriceRMB 1,880

ISPE Good Practice Guide: 践行生命周期模式的工艺验证指南

中文版本

Member PriceRMB 790
Standard PriceRMB 1,880

Good Practice Guide: Project Management for the Pharmaceutical Industry

Member PriceRMB 790
Standard PriceRMB 1,880

Good Practice Guide: Quality Lab Facilities

Member PriceRMB 790
Standard PriceRMB 1,880

Good Practice Guide: Sampling Pharma Water, Steam, & Process Gases

Member PriceRMB 790
Standard PriceRMB 1,880

Good Practice Guide: Single-Use Technology

Member PriceRMB 790
Standard PriceRMB 1,880

Good Practice Guide: Technology Transfer 3rd Edition

Member PriceRMB 790
Standard PriceRMB 1,880

Baseline Guide Vol 1: Active Pharmaceutical Ingredients

Member PriceRMB 1,080
Standard PriceRMB 2,180

Baseline Guide Vol 2: Oral Solid Dosage Forms 3rd Edition

Member PriceRMB 1,080
Standard PriceRMB 2,180

Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition

Member PriceRMB 1,080
Standard PriceRMB 2,180

Baseline Guide Vol 4: Water & Steam Systems 3rd Edition

Member PriceRMB 1,460
Standard PriceRMB 2,540

Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition

Member PriceRMB 1,810
Standard PriceRMB 2,910

Baseline Guide Vol 6 Biopharmaceutical Manufacturing Facilities 3rd Edition

English Version

Member PriceRMB 1,110
Standard PriceRMB 2,236

Baseline Guide Vol 7: Risk-Based Manufacture of Pharma Products 2nd Edition

Member PriceRMB 1,080
Standard PriceRMB 2,180

Baseline Guide Vol 8: Pharma 4.0 1st Edition

Member PriceRMB 1,110
Standard PriceRMB 2,230

APQ Guide: Cultural Excellence

Member PriceRMB 790
Standard PriceRMB 1,880

APQ Guide: Change Management (CM) System

Member PriceRMB 790
Standard PriceRMB 1,880

APQ Guide: Corrective Action & Preventive Action (CAPA) System

Member PriceRMB 790
Standard PriceRMB 1,880

APQ Guide: Management Responsibilities & Review (MRR)

Member PriceRMB 790
Standard PriceRMB 1,880

APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)

Member PriceRMB 790
Standard PriceRMB 1,880

PQLI Guide: Part 1 - Product Realization using QbD: Concepts & Principles

Member PriceRMB 790
Standard PriceRMB 1,880

PQLI Guide: Part 2 - Product Realization using QbD: Illustrative Example

Member PriceRMB 790
Standard PriceRMB 1,880

PQLI Guide: Part 3 - Change Management System

Member PriceRMB 390
Standard PriceRMB 1,480

PQLI Guide: Part 4 - Process Performance & Product Quality Monitoring System

Member PriceRMB 390
Standard PriceRMB 1,480

Guide: ATMPs - Autologous Cell Therapy

Member PriceRMB 1,450
Standard PriceRMB 2,540

Guide: Biopharmaceutical Process Development & Manufacturing

Member PriceRMB 1,080
Standard PriceRMB 2,180

Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls

Member PriceRMB 1,810
Standard PriceRMB 2,910

Handbook: Sustainability

Member PriceRMB 360
Standard PriceRMB 1,460

Comprehensive Guide to Clinical Materials

Member PriceRMB 550
Standard PriceRMB 1,650

Introductory US Clinical Trial Materials Training Guide

Member PriceRMB 60
Standard PriceRMB 95

Investigational Materials Sample Retention Guide

Member PriceRMB 25
Standard PriceRMB 70

D/A/CH Affiliate: WFI Handbook (English Translation)

Member PriceRMB 550
Standard PriceRMB 1,680

Japan Affiliate: Pest Control Manual (English Translation)

Member PriceRMB 550
Standard PriceRMB 1,680

2023 ISPE Drug Shortages Prevention Model

Member PriceComplimentary
Standard PriceRMB 550

ISPE Readiness Report Bundle

Member PriceComplimentary
Standard PriceRMB 550

The Cultural Excellence Report - Six Key Dimensions

Member PriceComplimentary
Standard PriceRMB 190

Guide: 503B Compounding

Just English Version

Member PriceRMB 1,080
Standard PriceRMB 2,180

Introduction of Guidance Documents

良好实践指南:制药行业的知识管理(查看简介请点击指南封面)

制药用水系列指南(查看简介请点击指南封面)

良好实践指南:基于膜技术的注射用水(WFI)系统

ISPE 基本指南:第 4 卷 – 水和蒸汽系统(第三版)

ISPE 良好实践指南:制药用水和蒸汽系统的调试和确认方法 第二版

ISPE 良好实践指南:关键公用设施 GMP 合规性

ISPE 良好实践指南:制药用水系统的臭氧消毒

ISPE良好实践指南:温控箱/室(第 2 版)