In this issue:
hot!
-
ISPE China Training Plan 2011
ISPE-CCPIE China Conference 2010 successfully held
-
Industry Leadership Forum 2010
-
Get the most out of your guidance documents with related webinars
Upcoming live webinars
-
ISPE China new leadership
-
Tracy Clemmer won ISPE Member of the Year Award
Congratulations to anther CPIP winner Joyce Chiu
-
Advertisement opportunities on Sterile and GEP
Call for PE articles on May/June issue
PE sponsorship opportunities available
Boehringer Ingelheim guided career development for students in in Sichuan University
KSP made suggestions on Career Development to students in Sichuan University
Student‘s journey on ISPE China Conference
hot!
hot!
hot!
hot!
hot!
Events:
hot!
ISPE China Training Plan 2011
ISPE China Training Plan 2011
Course
Instructor
Basic Principles of Computer System
Compliance
Lin Hong
Practical Application of Computerized Systems
Compliance
Sion Wyn
Biopharmaceutical Manufacturing Facilities
Nick Kotlarski
Auditing for GMP
Rory Budihandojo
A Risk-Based Approach to GxP Process
Control Systems
TBD
Click here for detailed information.
Date & Location
March, Shenzhen
28-29 March , Tianjin
31March-1 April , Shanghai
3-4 March, Shanghai
7-8 March, Tianjin
25-26 July, Shanghai
TBC, Tianjin
Fall, Tianjin
ISPE-CCPIE China Conference 2010 successfully held
With the theme of “Facilitating Internationalization of China
Pharmaceutical Industry”, ISPE-CCPIE China Conference 2010
was successfully held on 26-29 October 2010 in China National
Conference Center, Beijing.
Key note session featured on topics of China new GMP, facility
inspection and pharmaceutical industry business review while
break-out sessions featured on 7 key pharmaceutical industry
topics. Officials from SFDA and FDA, experts from international
& domestic pharmaceutical manufacturers and service
providers have joined the sessions.
Over a hundred delegates also joined the factory tours in Bayer, Sanofi-Aventis, Tongren Tang in Beijing and
Novonordisk, GSK and Tasly in Tianjin.
Around 420 delegates attended this conference and 92% of them think this conference is overall very good or
excellent.
Delegate’s Voice:
It is an excellent platform for us to share information & exchange ideas. We get the overall picture, latest
development and international trends & regulation through the keynote; breakout sessions give us great case
studies about difference aspects like implementation, execution and validation. This is a great learning
opportunity.
Jimmy Wang, Business Development Manager, Siemens Building Technologies (Tianjin) Co., Ltd,
I would like to call this ISPE_CCPIE China Conference 2010 a great success, especially the GAMP 5 session
which covers the whole life circle of the Computer Validation Project. And it is thoughtful for them to even work
out two very typical and professional reports. I am sure that these two reports will edify the congregation in the
China pharmaceutical industry greatly. Looking forward to an even better conference next year.
Xiangfei Meng, Sales Manager, Beijing NeoTrident Co., Ltd,
Industry Leadership Forum 2010
hot!
China Pharmaceutical Industry Leadership Forum was held
successfully in CNCC On 27th October, 2010. It was organized
by ISPE & CCPIE. Liu Yuan from SFDA, Brenda Uratani from
FDA, Huiliang Bai from China Pharmaceutical Entrepreneur
Association and over 40 other top managements from MNCs
and local Pharmaceutical companies participated in the forum.
Attendees discussed about the advantages and disadvantages
of the China pharmaceutical industry regarding costs, marketing,
talents, resources, etc. The discussion also brings out the
opportunities and challenges as well as the strategy at the
moment.
Next year, the forum will focus more the sustainable development of China Pharmaceutical Industry and we
look forward to your constant concern.
For more information, please click here.
Online Learning:
Get the most out of your guidance documents with related webinars!
hot!
ISPE has created a series of Webinars to further your education in reference to Guidance Documents. As an
added membership benefit, you’ll be able to either register for the live webinar at a discount or listen to the
recorded version. Find the related webinar next to the Guidance Documents including:
9
9
9
9
9
9
9
9
Risk MaPP series
GAMP5 series
Manufacturing Execution Systems(MES)
OSD (Oral Solid Dosage) series
API (Active Pharmaceutical Ingredients) series
HVAC (Heating, Ventilation, and Air Conditioning) series
The New Maintenance Good Practice Guide
C&Q series
Click here for the complete list.
Upcoming Live Webinars - Save the dates for these upcoming live webinars!
9
9
Quality Risk Management (QRM) Tool Selection: Getting to "Right First Time" – 12/9/2010
Development and Validation of an Integrity Test Method for a Sterile Connection Device: Correlation of
Integrity Test Limits to Loss of Integrity of Devices – 12/16/2010
Membership & COP News:
New leadership for ISPE China
hot!
ISPE China has just elected its new leaders after the vote in October 2010. Mars Ho, the CEO of Austar, was
elected as the new chairman and Dr. Zhao Chunhua from Bayer as the vice chairman. The new leadership has
started their work since November. Immediate past chair Jason Tang continues to contribute as board member
working together with other 14 members from Boehringer Ingelheim, Pfizer, Novo Nordisk, PriceWaterhouse,
Siemens, Sanofi Minsheng, etc.
Mars Ho has served in the pharmaceutical industry for 25 years in China and he is an ISPE member since
2002. He was selected as “60 elites 60 years” of pharmaceutical industry recently. Dr. Zhao Chunhua has been
working in the area of pharmaceutical engineering for more than 10 years, and he joined ISPE since 2006.
Board members will lead the 7 committees of ISPE China which are Technical, Regulatory, Promotion, Training,
Conference, Students & Young Professionals and Advisory Committee.
Contact Us or Click here should you feel interested in join ISPE volunteer team.
hot!
Tracy Clemmer won Member of the Year Award 2010
Tracy Clemmer won Max Seales Yonker Member of the Year
Award 2010, which honors the ISPE Member who made the
most significant contribution to the Society during the past year.
Clemmer was awarded this honor due to her involvement with
the rapidly-growing China Affiliate.
Congratulations to another CPIP winner Joyce Chiu
Joyce Chiu has achieved the Certified Pharmaceutical Industry Professional™ (CPIP™) credential by the ISPE
Professional Certification Commission (PCC), an independent governing board within ISPE.
“Now that I’ve completed the process, I have a great sense of achievement. Overall, the program is very well
designed and thought-out. Especially in the experience requirement leading to the eligibility to test, the CPIP
program espouses the leadership, change agent behavior that it strives for.” Chiu has been a Member of ISPE
since 2007. She has over 20 years experience in technical fields related to chemistry and chemical
engineering. She believes that CPIP is relevant to any industry spanning product development to
manufacturing.
Click here for more information on the CPIP program.
Featured Resources:
hot!
Sponsorship opportunities for Chinese version of Sterile and GEP
ISPE China plans to translate ISPE Good Practice Guide: Good Engineering Practice and Baseline Guide:
Sterile Manufacturing Facilities. Sponsorship opportunities are available now:
9 Advertisement in inside front cover / back cover/inside back cover
9 Exposure on ISPE official website (technical publication page)
9 one-year-exposure on ISPE Chinese website (technical publication page)
Practice Guide: Good Engineering Practice covers the complete life cycle of engineering, from concept to
retirement, and describes the fundamental elements of GEP which should exist in pharmaceutical and related
industries.
Baseline Guide Volume 3: Sterile Manufacturing Facilities addresses the design, construction,
commissioning, and qualification of new or renovated sterile manufacturing facilities, covering facilities for both
aseptic processing and terminal sterilization of formulated products, generally for parenteral use.
Contact us or click here for more information.
Call for PE articles
Pharmaceutical Engineering, the global information source for pharmaceutical science and manufacturing
professionals, is issuing an international call for articles and case studies for the May/June 2011 issue with an
editorial focus on Green, Sustainable, and Efficient Pharmaceutical Manufacturing and Development.
Topics could be sustainability, green manufacturing, LEED design, energy optimization and efficiency, waste
reduction, disposables, manufacturing waste handling, recycling opportunities, quality by design, cost of goods
reduction, and decreased risks. We also look for case studies that demonstrate the holistic approaches used to
implement sustainable manufacturing.
The article submission deadline is 3 January 2011.
For more information, please visit www.ISPE.org and click on Publications and Pharmaceutical Engineering.
PE sponsorship opportunities available
PE (Pharmaceutical Engineering) magazine is the leading global information resource for the pharmaceutical
and biotechnology manufacturing industry. Reviewed by editorial board of ISPE, the magazine is published bimonthly for ISPE Members. Articles and case studies cover the latest industry trends, technical developments,
topics of interest and feature practical applications and specific industry information. It is circulated to over
30,000 industry professionals in more than 90 countries. 67% subscribers are actively involved in the decisionmaking or influencing the decision of purchasing specific products.
Sponsorship opportunities are available; Click here for ISPE Global Media Planner and more advertisement
information.
Student & Young Professionals:
Boehringer Ingelheim guided career planning for students in in Sichuan University
Mr. Andreas Bahne (Chair of ISPE Student & Young
Professional Committee; Plant Expansion Project of Boehringer
Ingelheim) made a speech about “Career Orientation-Career
Opportunities in Pharmaceutical companies for technical
professionals” in Sichuan University on Nov. 24th. The speech is
mainly focused on introducing pharma company`s daily work,
project management and career development. Over 40
attendees including students and teacher attended this lecture.
Student representative Wang Xin presented a hand-writing map
of Sichuan University to Mr. Bahne as a gift.
Mr. Andreas also had a discussion with chapter members about
the chapter development & action plans later on.
KSP made suggestions on career development to students in Sichuan University
Wei Hong and Li Jia from KSP (Chen Du) delivered “career building after school” speech in Sichuan University
recently.
Mr. Wei took his own life experience as an example. He shared his hard way to college and experience of
being looked down on during his internship, to point out that only through tough environment could a person
succeed eventually. Mr. Li distributed 4 pieces of advice - clear logical thinking ability, self –definition and
ability to find gap, to be careful and meticulous to do things and to be good at studying and innovating. These
abilities are the capital to find work in the future.
“We benefited a lot from the lecture. I believe if we have the will and abilities as the two managers adviced, we
will have a bright future” said Wang Xin, a student in Sichuan University who took the lecture.
Students’ journey on ISPE China Conference
Michael Wangxin and Zhang Benhe in Sichuan University attended the ISPE-CCPIE China Conference 2010 in
Beijing. They are excited about their journey, “As a learner, we got large amount of information from those
wonderful lectures, such as the new GMP, PAT, GAMP etc. We also got an overall understanding of
pharmaceutical industry’s current situation and challenges in future. The conference gave us very good social
networking opportunities as well; we are introduced to many contacts in this industry”.
Click here for more information about activities in Sichuan University of ISPE Student Chapter.
广告机会 Advertisement – Broadcast your company brand to the world!
在ISPE官方网站、中文网站和《制药工程》杂志刊登广告，建立品牌知名度！详情请联系 ISPE 中国
办公室。
Advertisement opportunities at ISPE main website ISPE Chinese websites, and even on one of the
most famous magazine in pharmaceutical industry- PE( Pharmaceutical Engineering) to broadcast
your company to the world and establish your authority brand! For more details,please contact
Jackie Liu,
ISPE China membership& Affiliate Relations Manager.
ISPE 中国办公室 ISPE China Office
Tel: +86 21-5116 0265
Fax:+86 21-5116 0260
Email: china@ispe.org
Add: 上海市静安区陕西北路66号科恩国际中心2302室，200041
Suite 2302,Wise Logic International Center
No.66 North Shanxi Road Shanghai ,China 200041