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发布时间: 2018-12-14
为FDA 和EMA cGMP 合规检查做准备

为FDA 和EMA cGMP 合规检查做准备

会议时间:2019-03-07 至 2019-03-08 结束

会议地点:上海 上海

联系人:

会议先容

学习目标Objective

The objective of this course is to provide participants with the information they need to implement and operate a Quality Management System that meets the expectations of international regulatory agencies.

本课程旨在为参与人员提供第一手的信息,使他们清楚如何建立及运行一个满足国际药品监管机构希望的质量管理体系。

本实践课程将帮助您理解:This hands-on course will provide you with an understanding of

如何与FDA 和EMA 的审查员一起工作how to work with FDA and EMA inspectors

如何开发满足国际标准的质量管理体系。how to develop Quality Management Systems that meet international requirements

文档要求QMS document requirements QMS

操作步骤要求operating procedure requirements

设施和仪器要求facility and equipment requirements

质量控制要求Quality Control requirements

什么是合规以及做到合规意味着什么what is compliance and what does it mean to be in compliance

合规的需要有哪些?what are the requirements for compliance

大家如在所有不同级别的员工那里建立质量观念how do we develop a quality mindset among all levels of employees

以下群体将从本培训中获益The following people would benefit from this training

质量管理经理和总监Quality Assurance managers and directors

生产经理和总监Manufacturing managers and directors

法规经理和总监Regulatory affairs managers and directors

会议议程 (最终议程以会议现场为准)

培训内容:The agenda includes the following topics

09:00   先容Introduction

课程目的  purpose of course

讲师先容  instructor introduction

学生先容 student introductions

检测方法  test method

09:30   什么是合规What is compliance

是态度而不是规则 attitude, not rules

审查员的目标 the goal of the inspector

抽样类比 sampling analogy

标准的定义及在哪里找到它们 definition of standards and where to find them

10:00   质量体系的构成Components of a Quality System

质量管理体系钻石图及所含区域 introduction to QMS diamond and listing of areas合规的一些关键问题 key issues in compliance

数据真实完整性 data integrity

风险评估 risk assessment

10:30   质量管理体系1Quality Management Systems 1

文案 Documentation

纠正预防措施及偏差 CAPA and Deviations

变更控制 Change Control

12:00   午餐Lunch

13:00   质量管理体系2Quality Management Systems 2

内部审计 Internal Audit

培训 Training

14:30   操作Operations

批记录 Batch Records

洁净室 Cleanrooms

16:00   厂房和设施Facilities

公用设施:注射用水系统 Utilities: HVAC and WFI

维修保养和校准 Maintenance and Calibration

17:30   会议结束 End Of Day One

会议第二天Day Two

09:00   质量控制Quality Control

方法验证 Method validation

超规 OOS

10:30   验证Validation

设备认证 Equipment qualification

电脑系统验证Computer system validation

12:00   午餐Lunch

13:00   和检查员一起工作 Working with inspectors

有哪些期待what to expect

如何互动how to interact

14:00   总结和回顾  Summary and review

14:30   会议结束  End Of Day Two

会议嘉宾 (最终嘉宾以会议现场为准)

培训专家Trainer


联合创始人和首席顾问Scott M. Wheelwright博士智真生物的联合创始人兼首席顾问。Wheelwright博士与不同类型的制药和生命科学企业有过合作,帮助他们符合国际质量标准。Wheelwright博士拥有发酵、细胞培养、单克隆抗体、蛋白质和病毒等相关的专业技术常识。Wheelwright博士曾直接参与治疗肿瘤、感染性疾病、心血管疾病、伤口愈合、血管生成的药物、以及疫苗和诊断药物的开发。过去30年,Wheelwright博士一直在帮助企业解决药物产品由研究进入商业销售阶段时遇到的问题。

Wheelwright博士也是SMW企业的创办人和总裁,SMW是一家提供有关生产操作和质量保证cGMP符合性的美国咨询企业。SMW还为生物技术和相关云顶国际登录官网提供运营管理、生产外包、CMC开发活动和厂房设计等方面的业务和技术支撑。此前,Wheelwright博士是Innovent的创始人之一并一直担任COO。Innovent是一家中国生物制药企业,主要开发和生产单克隆抗体产品并在中国和全球销售。Innovent设计了容量超过70000L的大型cGMP细胞培养生产厂房。

Wheelwright博士曾经在多家生物技术创业企业担任实行官,并负责监督生产、工艺开发、符合性、质量保证、质量控制、验证、工程和设施等方面的工作。Wheelwright博士曾经作为研究员在实验室工作,并领导过一些已上市产品的开发。Wheelwright博士还领导建设了多个符合cGMP要求的工厂。Wheelwright博士工作过的企业包括雅培、Chiron(现为诺华)和Scios(现为强生)。

Wheelwright博士在犹他州大学取得化学工程专业学士学位,在加州大学伯克利分校获得化学工程专业博士学位。他在德国马克斯普朗克研究所进行博士后生物物理学研究。Wheelwright博士有一本关于蛋白质纯化的着作,并发表了多篇关于工艺设计、制造、生物药和生物制剂符合性的论文。

Dr. Wheelwright is founder of Complya Asia Co., Ltd., a consultancy focused on improving the quality of pharmaceutical practice in China.  Dr. Wheelwright was founding Chief Operations Officer with Innovent Biologics, one of the leading biopharmaceutical development companies in China.

Dr. Wheelwright has been an executive officer in several biotech startups, and has supervised the areas of manufacturing, process development, compliance, quality assurance, quality control, validation, engineering and facilities.  He has worked as a researcher in the laboratory and has led the development of several products that are now on the market.  He has led the construction of multiple manufacturing facilities that meet the international compliance requirements for current Good Manufacturing Practice (cGMP).

Dr. Wheelwright has over 30 years experience in solving the challenges companies encounter when bringing biotech, pharmaceutical, and other medical products out of research and into the commercial marketplace.

Dr. Wheelwright obtained his PhD degree in chemical engineering from the University of California at Berkeley and his BS degree in chemical engineering from the University of Utah.  He performed post-doctoral studies in biophysics at the Max Planck Institute in Germany.  Dr. Wheelwright is the author of a book on protein purification and has published many papers on process design and manufacturing for biotechnology.

概述Overview

开发并实行满座国际希望的质量方案对很多企业来说都是一个挑战。挑战的一部分是理解国外监管机构的要求,另一个挑战是改变员工的思想方式,是他们认识到他们可以一直保持合规(是的,这是可能的。)Developing and implementing Quality programs that meet international expectations is a challenge for many companies.  Part of the challenge is understanding the requirements of foreign regulatory agencies.  Another challenge is changing the way of thinking of employees to recognize how they can always be in compliance (yes, this is possible!).

在培训中,你将会学到为了确保质量体系符合国际质量确认标准,你需要做什么。大家将审视质量管理系统里的每一部分并且确认常见问题,制定克服问题的方案。大家将讨论企业在把它们的合规表现呈现给审查员时面临的问题,以及如何帮助审查员来理解大家真实的合规水平。

In this training you will be taught what you need to do to ensure your quality system is in compliance with international standards for Quality Assurance.  We will go through each of the Quality Management Systems and identify common issues and how to overcome them.  We will discuss the problems companies face in presenting their compliance performance to inspectors and how to help inspectors understand our true level of compliance.

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