SHANGHAI, March 27, 2013 /PRNewswire/ -- Quality by Design (QbD) principles are familiar to pharmaceutical companies, and there are many trainings or conferences that focus on the introduction of this idea. However, how to practice these principles and how to make it from idea to implementation is still difficult for them.
Based on this background, the Quality by Design 2013 Conference organized by CPhI will be held on April 17 and 18 in Crowne Plaza Century Park Shanghai.
This event will be themed "From Idea to Practice, Gearing up for Pharma QbD through Practical Examples" and will focus on QbD implementation methods, including five in-depth case analyses from the perspective of generics, API and solid dosage forms R&D. QbD methodology also will be explored in this event, including DoE, PAT and RTR technology. Since QbD principles are more and more important in drug applications, according to updates of regulations, standards of FDA/SFDA and QbR evaluation models will be discussed in this event too, and attendees will benefit from the latest regulatory exploring.
Eighteen speakers will gather at this grand meeting. Luke Wang, senior director of product development from Huahai US, will talk about the experience of combining the generics application in Huahai.
Dr. Ke Hong, senior manager of PAT projects in Pfizer Global Supply, will focus on the case study of PAT-enabled QbD in drug manufacturing.
Dr. Ziqiang Gu, a former FDA officer, will talk about the FDA's expectation for QbD approaches in drug development.
The vice president from Novast Laboratories Ltd, general manager of Shanghai No.1 Biochemical & Pharmaceutical Co., Ltd, vice president from Syrex Laboratories Inc. and the former vice president from Teva will come together at this event for the deeper analysis of QbD. All the keynote speakers and panel guests have rich overseas R&D experience and have participated in QbD projects in their careers.
Recently, the organizer interviewed Pedro Hernandez, Senior Director of Quality Assurance from Frontage Laboratories Inc., and Mehtap Saydam, R&D Specialist from Sanovel Pharmaceuticals, about the five hottest QbD topics.
- How to understand the fundamental impacts of QbD in the pharmaceutical industry, and the basic principles and tools of QbD?
- How to practice QbD in the areas of generics, API and excipients?
- How to use PAT/DoE and other specific methodology in QbD practice?
- How to clarify the QbD implementation standards, such as new GMP and QbR?
- How to utilize FDA and EU regulations with QbD to get through the evaluation process?
For their answers to the questions above, please click www.qbd-china.com to download them for free.
Now, more than 60 pharmaceutical companies have registered for this event, including Hisun, Hengrui and Celltrion Pharm, which are famous in China and overseas. To download a full attendees list, please visit www.qbd-china.com.
For more information or questions, please call +86-21-6157 3930 or email firstname.lastname@example.org.
Ms. Tracy Cui
Tel: +86-21-6157 3919
Fax: +86-21-6157 7299
SOURCE CPhI Conferences