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Free Seminar by International Expert on Quality by Design    

质量源于设计免费研讨会 — 国际专家主讲

Complya Asia is hosting a seminar on the application of Quality by Design to product development.  In this seminar international expert Dr. Thomas A. Little will present the basic concepts of QbD as it applies to process design and analytical method design in the pharmaceutical, biopharmaceutical, and diagnostic industries.  In recent years, European and American drug policy and regulations are frequently updated and the requirements for drug development and production have never been higher.  The concept of Quality by Design in pharmaceuticals has become increasingly important to international regulators.

苏州智真生物技术咨询有限公司正在筹备关于质量源于设计应用到产品开发的研讨会。在本次研讨会,国际专家Thomas A. Little博士将诠释质量源于设计的基本概念,即关于它如何适用于制药、生物制药和诊断行业中的工艺设计和分析方法的设计。近年来欧美药政法规不断更新,对药品研发与生产的要求越来越高,尤其是质量源于设计理念在整个制药领域中的重要性越发突出。

On December 3rd, 2015, we will hold a seminar on Quality by Design, Modern Drug Development and Critical Quality Attributes, at a hotel in Shanghai Pudong near Liujiazui.  Dr. Little, a world-renown expert in QbD, who will address the following topics: 10 Elements of Quality by Design, Practical Applications and Use of Design Space, Case Studies and Examples of Modern Drug Development per FDA and EMA, Application to Process Development and to Analytical Development, and Development and Regulatory Implications.

2015123,关于质量源于设计(QbD)、现代药物开发和关键质量属性研讨会将于上海浦东陆家嘴上海浦东假日酒店举行。QbD世界知名专家Little博士将介绍如下课题:质量源于控制的十大要素、设计空间的实际应用和使用、现代药物开发中根据FDAEMA要求的案例研究及实例介绍、工艺开发和分析开发的应用、开发和监管影响。

We invite you to participate! Please register today by contacting Juan (Juan.Shao@complya-asia.com; 0512- 6726 2997) to confirm your interest and obtain further information.  Space will be limited, so register early. Lunch is included.  This is a rare opportunity so don’t delay. 

欢迎业内人士踊跃参加! 如果您感兴趣想进一步了解详细信息,欢迎随时联系邵娟报名注册(Juan.Shao@complya-asia.com; 0512- 6726 2997)席位有限,请尽快报名包含午餐。机会难得切勿错过。

会议时间: 2015年12月03 日 9:00-16:00

会议地址:

上海浦东假日酒店

Holiday Inn Shanghai Pudong

中国上海市浦东新区东方路899号(近向城路)邮编:200122

899 Dong Fang Road, Pudong Shanghai 200122 P. R. China

会议日程:

Time

Title

Speaker

Company

9:00 – 9:15

Welcome and Introduction

Scott   M. Wheelwright, PhD

Complya Asia

9:15 – 10:30

Establishing a clear line of sight from clinical to product release   and stability

Thomas   A. Little, PhD

Thomas   A. Little Consulting

Quality risk management in every aspect of development (QTPP, CQAs,   High and Low Level Risk Assessment)

10:30 – 10:45

Break

10:45 – 12:00

Enhanced product knowledge (Product Characterization, Formulation, Forced   Degradation, Stability)

Thomas   A. Little, PhD

Thomas   A. Little Consulting

Assay understanding and control (Robustness, Stability, ATP Profilers,   and Method Validation)

Process understanding and characterization (Process Characterization, NOR/PAR,   and CPPs)

12:00 – 13:00

Lunch

13:00 – 14:15

Generation of transfer functions (DOE, Design Space, Edge of Failure,   Capability and Control)

Thomas   A. Little, PhD

Thomas   A. Little Consulting

Improved product specification limits and justification (Distribution   and Transfer Functions)

14:15 – 14:30

Break

14:30 – 16:00

Robust design space and edge of failure analysis (Regulatory   Implications)

Thomas A. Little, PhD

Thomas   A. Little Consulting

Use of modern control strategies and PAT (Enhanced Process Control)

Continuous improvement and validation throughout the product lifecycle


Speaker Introduction

Thomas A. Little, PhD

Dr. Thomas A. Little is President of Thomas A. Little Consulting (TLC) an internationally recognized consulting firm with a proven record for achieving results. He has extensive experience in developing and deploying Six Sigma programs aligned to core management and business objectives. Dr. Little has developed curricula in manufacturing excellence with Six Sigma, transactional excellence with Six Sigma and design for Six Sigma in product, service and business development.

In addition to Six Sigma course development, Dr. Little has developed specific content courses in engineering statistics, data analysis, design of experiments, performance modeling, statistical process control, measurement systems analysis, mixture design of experiments, root cause analysis, process mapping and failure modes and effects analysis. These courses are used by a variety of Fortune 100 companies to train their engineers and scientists.

Scott M. Wheelwright, PhD

Scott M. Wheelwright, PhD, is cofounder, principal consultant and president of Complya Asia. His experience includes many types of pharmaceutical and life science companies, helping them meet international standards for quality.  Dr. Wheelwright has technical expertise in fermentation, cell culture, monoclonal antibodies, proteins and viruses. He has directly participated in developing oncology, infectious disease, cardiovascular, wound healing, angiogenesis, vaccine and diagnostic products. His 30 years experience in solving the challenges companies encounter when bringing biotechnology and other medical products out of research and into the commercial marketplace and his many years in Asia enable him to support many types of projects.

Previously, Dr. Wheelwright served as the founding Chief Operating Officer for Innovent. Dr. Wheelwright has been an executive officer in several biotech start-ups, and has supervised the areas of manufacturing, process development, compliance, Quality Assurance, Quality Control, validation, engineering and facilities. 

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时间

2015-12-03 08:30 - 开始

2015-12-03 16:00 - 结束

已结束