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2013 ISPE Public Training Series 1 will be held in Shanghai on June 20-22
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ISPE will organize the ICH Q10 Workshop in Beijing on Nov 19-20
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ISPE 2013 Annual Meeting will be held in Washington this Nov 3-6
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ISPE has formed an alliance with PMMI
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ISPE China Annual Conference 2013 was successfully held in Beijing
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ISPE China participated in the 45 CIPM
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An open community - ISPE China Committees are recruiting volunteers Hot!
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Student Internship Program –Volunteers recruitment
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2013 ISPE Public Training Series 1 will be held in Shanghai on June 20-22
2013 ISPE Public Training Series 1 will be held in Shanghai on June 20-22. Register and finish
the payment before May 20, you will enjoy the discount price. Public Training Series 1 includes
3 individual courses:
Course: Basic Principles of Computerized Systems Compliance using GAMP®, Including
Revised Annex 11 and Part 11 Update
Lecturer: Hong Lin, Director of Life Sciences Vertical from MES, Siemens Industry Software
(Shanghai), Chair of ISPE China Training Committee;
Date: June 20-21
Course: Applying Quality Risk Management
Lecturer: Hongyang Li, Head of Quality, Suzhou Novartis Pharmaceutical Technology, Chair
of ISPE China Regulatory Committee;
Date: June 21-22
Course: Sterile Products Manufacturing Facilities
Lecturer: Jun Wu, CFDA Training Centre visiting professor;
Date: June 20-21
Click here to register online. Please call 021-51081512 or visit www.ispe-event.org.cn for more
information.
ISPE China Public Training uses the expertise of its global members to develop courses that
address the current need to meet industry requirements. ISPE public training is a recognized
opportunity for in-depth, topic-specific learning that will help you obtain excellent effects in
lower production costs, increase production quality, improve process efficiency and meet
regulatory requirements, etc.
Please find other 2013 ISPE China Training Series introduction below:
Public Training Series 2 (August, 2013, Chengdu)
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Applying Quality Risk Management（Hongyang Li）
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Practical Application of Computerized Systems Compliance（Hong Lin）
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Application of Commission and Qualification（Peter Ma）
Public Training Series 3 (October, 2013, Shanghai)
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Oral Solid dosage Forms（Jifeng Lei）
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Science and Risk-based Commissioning and Qualification
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GMP Auditing for the Pharmaceutical Industry
ISPE will organize the ICH Q10 Workshop in Beijing on Nov 19-20
At the suggestion of FDA, ISPE will organize an ICH-Q10 workshop in Beijing on November
19-20 this year, which provides information, education and networking for companies and
regulators on the principles of ICH Q10.
This is a significant workshop in the ICH Q10 journey. 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.
Please visit http://www.ispe.org.cn for more information.
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 has formed an alliance with PMMI
ISPE has formed an alliance with PMMI, the Association for Packaging and Processing
Technologies, to develop an all-new trade show: Pharma EXPO will debut 2 – 5
November 2014 at McCormick Place – West Building, in Chicago.
Pharma EXPO will be held in conjunction with PMMI’s PACK EXPO, one of the world’s most
respected and successful manufacturing, packaging and processing events. Our new joint
event will be held annually and take place in Chicago and Las Vegas on alternating years.
As like-minded, not-for-profit associations with related missions, ISPE and PMMI share a
commitment to advance the manufacturing industry. By working closely with PMMI on the
planning and execution of Pharma EXPO, we are opening new opportunities and offering a
new marketing platform for exhibitors, including the chance to meet new buyers from around
the globe.
For more information about ISPE’s partnership with PMMI, we invite you to explore our
Frequently Asked Questions (FAQ) list. For more information, or if you are interested in
speaking or exhibiting, please email: PharmaEXPO@ispe.org.
ISPE China Annual Conference 2013 was successfully held in Beijing
ISPE China Annual Conference 2013 was successfully held in Renaissance Beijing Capital
Hotel on April 22-23. Centring round theme of “Promote Innovation and Transformation of
China Pharmaceutical Industry; With Global Approach of Regulatory & Technical
Advancement”, the conference set 5 individual tracks including “Regulatory, Quality and GMP”,
“Facility and Engineering”, “Drug Product and Manufacturing Process”, “Biological Drug
Development and Manufacturing” and “Investigational Product/Clinical Supplies”.
The speakers are composed of industry leaders from global pharmaceutical companies e.g.
Pfizer, Novartis, Bayer, Merck, as well as regulatory officials from CFDA and MHRA. They
shared the latest industry trends and best practices with almost 500 attendees.
“I have impressive experience and felt happy to find many authorities and friends concern of
same field in China.” From Koji Kawasaki, leader of ISPE SPP-COP Japan.
“It’s great to meet so many experts who can share the perspectives and trends of
pharmaceutical industry. I really gain a lot in ISPE conference.” Miss. Cui, Shenzhen Main
Luck Pharmaceuticals Inc., Head of Quality
Conference attendees please kindly click here to download all speakers’ slides. PS: We will
send all conference attendees the unzip code soon.
Visit http://www.ispe-event.org.cn/2013ISPEChinaConference/EN/ for more ISPE annual
conference information.
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ISPE China participated in the 45 CIPM
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ISPE China participated in the 45 CIPM, which was held in Qingdao on April 24-26. In the
conference, ISPE lecturers gave the speeches of “The application of lean manufacturing in
GMP”, “How to build the quality management system which complies with new GMP” and
“Combine the QBD into the technology validation”.
An open community - ISPE China Committees are recruiting volunteers! Hot!
In ISPE Annual Conference 2013, Charles Tong, 2013-2014 Chairman of ISPE China,
officially announced the establishment of 9 professional committees:
Supporting committee:
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Membership Development Committee
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Training Committee
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Conference Committee
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Students and Young Professionals Committee
Technical committee:
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Regulatory Committee
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Chemical Drug Product and Process Committee
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Biological Drug Product and Process Committee
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Manufacturing and Engineering Committee
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Clinical Supplies Committee
The establishment of these 9 professional committees indicates that ISPE China’s
development has entered the specialization stage. In the future, these committees will be
responsible for different functions, to organize more events and generate more professional
resource, bring better service to ISPE members. If you want to join us to contribute to the
pharmaceutical industry, please click here to apply for ISPE China volunteers.
Student Internship Program –Volunteers recruitment
ISPE have been engaged in providing students abundant enterprise resource to advance their
social practice. To facilitate the cooperation between students and companies, we help
students to find their career opportunities as well as help companies to find the ideal talents.
ISPE China Student Internship Program is in hunting for volunteers. Please join us and recruit
your future industry elites! Call 021-51081512 for more information.