In this issue:
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2013 ISPE Public Training Series 2 will be held in Chengdu on Aug 23-24
2013 ISPE Public Training Series 1 was held in Shanghai on June 20-22
2013 ISPE-CCPIE CHINA CONFERENCE will be held in Shanghai on Oct 30-Nov 1
ISPE Pharmaceutical Quality System (ICH Q10) Conference will be held in Beijing on Nov 19- 20
ISPE 2013 Annual Meeting will be held in Washington this Nov 3-6
ISPE Membership Ambassador Recruitment Program
The latest ISPE Guide Series：PQLI Part 4！Hot！
Events:
2013 ISPE Public Training Series 2 will be held in Chengdu on Aug 23-24
2013 ISPE Public Training Series 2 will be held in Holiday Inn Chengdu Oriental Plaza on Aug 23-24.
Register and finish the payment before July 19，you will enjoy the discount price. Public Training Series 2
individual courses:
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includes 2
Quality Risk Management includes Regulatory background, process and roadmap, Process Risk Assessment, QRM
tools formal versus informal, Risk decision tree/matrix, etc.
Instructor: Hongyang Li, Head of Quality at Suzhou Novartis Pharmaceutical Technology, chair of ISPE regulatory
committee.
Application of Commission and Qualification will apply the principles of the Commissioning and Qualification
Baseline® Guide for a project consisting of process equipment components, classified area, critical utilities, and an
associated automation platform.
Instructor: Peter Ma, manager of the Validation Test Service department of Austar Group, ISPE senior instructor.
For more information please call 021-51081512 or visit http://www.ispe-event.org.cn/ISPEchinatraining/
Public Training Series 3 (October, 2013, Shanghai)
 Oral Solid dosage Forms（Jifeng Lei）
 Science and Risk-based Commissioning and Qualification（Peter Ma）
 GMP Auditing for the Pharmaceutical Industry
2013 ISPE Public Training Series 1 was held in Shanghai on June 20-22
2013 ISPE Public Training Series 1 was successfully held in Shanghai on June 20-21. Nearly one hundred students
attended the course of “Basic Principles of Computerized Systems Compliance using GAMP®, Including Revised Annex
11 and Part 11 Update” and “Sterile Products Manufacturing Facilities”.
We selected the hottest topic in pharmaceutical industry and invited the prestigious experts to be the instructors. The
students were deeply engaged into the content and discussion, and had a fantastic experience via instructors’
knowledge, practice and views.
For more information please visit www.ispe-event.org.cn/ISPEchinatraining/
2013 ISPE-CCPIE CHINA CONFERENCE will be held in Shanghai on Oct 30-Nov 1
The 2013 ISPE-CCPIE China Conference, which is jointly organized by CCD (Center for Certification of Drug), CCPIE (China
Center for Pharmaceutical International Exchange ) and ISPE, will be held on October 30-Novernber 1 in Jumeirah
Himalayas Hotel Shanghai.
Conference highlights:
 Authoritative: Introduce the implementation of the revised Pharmaceutical GMP certification and inspection.
 High End Technology Sharing: The ideal platform to learn the latest information from global experts as well as the
industry technology development trends.
 Best Practice Case Study: Leverage insight and analysis via demonstration of successful qualification cases of newly
amended GMP to unveil the key factors.
 Premier Trade Opportunity – Grand networking banquet to maximize your communication with industry players.
Who will attend?
 Senior management of pharmaceutical companies
 Senior management of pharmaceutical equipment business companies
 Officials of Provincial Food and Drug Administration
 Drug GMP inspectors
The price:
 International Forum: 2200RMB （ISPE member only）
 Revised drug GMP workshop: 2200RMB （ISPE member only）
 International Forum on Drug GMP + Revised drug GMP workshop: 3400RMB （ISPE member only）
Registration/Sponsor：
 TEL：86-10-82212866-6018, E-mail：zf@ccpie.org, Mr. Zhu
For more information please visit http://ispe.china-pharm.net/en/index.html
ISPE Pharmaceutical Quality System (ICH Q10) Conference will be held in Beijing on Nov 19-20
At the suggestion of FDA, ISPE will organize the Pharmaceutical Quality System (ICH Q10) Conference in Beijing on
November 19-20 this year, which provides information, education and networking for companies and regulators on the
principles of ICH Q10.
With the big support of FDA, we successfully invite FDA officials as well as the managements of the industry giants, to
have a deep discussion about the hot topics of ICH Q10. The program is timely with the on-going implementation of
GMPs in China and the opportunity to emphasize sterile manufacturing case studies. We are looking forward to your
participation.
While this conference is intended to explain the principles of ICH Q10, it is not a conference that only tells you what ICH
Q10 says. It is an event where you can learn the practicalities of how to implement Q10 based on real-life case studies. It
will show you how senior management commitment and involvement is vital.
Who shall attend?
The decision-maker at mid-level or senior level, or a professional working at site or corporate level in the following areas:
 Quality Assurance, Quality Risk Management
 Manufacturing, Operations and Engineering
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Supply chain
Regulatory Affairs
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We will keep in updating the latest conference agenda on http://www.ispe.org.cn.
This is the first time we organize the top level conference focusing on ICH Q10, which will bring the industry leaders and
regulators together. It should be the best opportunity to brand your company. Please call 021-51752617 for the details
of sponsorship.
ISPE 2013 Annual Meeting will be held in Washington this Nov 3-6
The ISPE 2013 Annual Meeting brings together global industry and regulatory experts to provide you with the latest
innovative processes, technologies, and quality management techniques to accomplish your goals. Join this influential
gathering of global pharmaceutical professionals in a dialogue centred on “Quality Throughout the Product Lifecycle”.
Every session will address an important piece of the product, process and supply chain interfaces. Acquire valuable tools
for creating and maintaining quality systems and final products that exceed regulatory standards. Don’t miss this
opportunity to gain and share knowledge in this dynamic and challenging network of your industry colleagues.
ISPE Membership Ambassador Recruitment Program
To expand ISPE’s information, knowledge and business opportunities to more professionals in pharmaceutical industry,
ISPE initiated its Membership Ambassador Recruitment Program. Any member who successfully recommends someone
else to become an ISPE member will be eligible to win a free ticket for 2013 ISPE China public training, ISPE technical
guide as well as ISPE magazine, etc.
Book Recommendation
The latest ISPE Guide Series：PQLI Part 4！Hot！
®
®
ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI ) from Concept to Continual Improvement Part 4 –
Process Performance and Product Quality Monitoring System (PP&PQMS)
®
The ISPE PQLI Guide: Part 4 – Process Performance and Product Quality Monitoring System serves as practical how-to
guidance with examples of technical and scientific methodology for adopting a process performance and product quality
monitoring system (PP&PQMS) in line with the expectations of ICH Q10, Pharmaceutical Quality System.
By establishing a PP&PQMS, your company can improve opportunities to:
 Maintain compliance with global regulations
 Improve confidence that a process runs as intended
The Guide introduces the role of Quality Steward as an owner of product quality. Responsibilities of the role are
discussed for this new concept emerging from industry.
This PQLI Guide is relevant for:
 New and existing products
 Small and large molecule
 All phases of product lifecycle, from development through product discontinuation
Buy One Guide and Save 20%，buy Two Guides and Save 25%.Offer Ends 30 June.
 ISPE PQLI® Guide: Part 3 Change Management System as a Key Element of a Pharmaceutical Quality System
 ISPE PQLI® Guide: Part 4 Process Performance and Product Quality Monitoring System
Please call 021-51081512 order your guide today.