In this issue:
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ISPE will host 2 Training Series in Beijing in November
ISPE China conference will be held on April 2013
The 2012 ISPE Annual Meeting will held in San Francisco in November
Choose your interested topics of ISPE trainings, win free training ticket!
Two ISPE Chinese Technical Guides to be published
ISPE new publication update
Free Downloading ISPE Technical Documents – member only
ISPE monthly gift-member only
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The 2 ISPE Student Poster Competition has successfully held
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ISPE will host 2 Training Series in Beijing in November
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ISPE will host 2
Training Series in Beijing in November
On the 29th-30th of November of 2012, ISPE will host the last training series of the year in Mercure
Wanshang Beijing (venue name)
ISPE training- Beijing
Date: Nov 29-30, 2012
Venue: Mercure Wanshang Beijing
Topic and instructor:
-Biopharmaceutical Manufacturing Facilities: Applying the Biopharmaceutical Manufacturing Facilities
Baseline® Guide Principles-Zhou Jing
-HVAC for Pharmaceutical Facilities-Yang Yi Xin
-Cleaning Validation-Liu Shu Lin
For more training information please feel free to visit http://www.ispe-event.org.cn/
On August of 2012, ISPE held a training in Shanghai themed as “Sterile, C&Q, and Computerized
Systems Compliance”. The training has attracted more than 200 participants. The guest professor of
SFDA training center, Mr. Wu Jun and other two experienced instructors brought in very deep
knowledge and explanation with the assigned topics. Meanwhile, the audience offstage has discussed
the problem they encountered at day-to-day work.
ISPE China conference will be held on April 2013
On April 22-23, 2013, ISPE China conference will be held in Shanghai. The conference will focus on
“The application of R&D method of science and risk into the PQLI” as well as the hot topic about
cGMP. The conference is dedicated to share the global insight and penetrate into the up-to-date case
studies, provide the most practical GMP solution.
We will invite the officers from US FDA, EMA, PMDA, PIC/S, Chinese regulatory organization, the
authors of ISPE publications, as well as the industry leaders from international pharmaceutical and
engineering companies. ISPE encourages innovation and transformation; we are looking forward to
seeing you on April, 2013 in Shanghai!
Please visit our website http://www.ispe.org.cn/ and our Weibo:www.weibo.com/ispechina
to see more details.
Link to the past conference: April 16-17, 2012, the big event of pharmaceuticals industry was
successfully held in Beijing. More than 500 participants including governmental officers, industry
senior leaders, and professionals attended the conference. The conference featured 3 topics” Product
& Process, Manufacture & Quality Management, Facility design, refurbishment and operational
management”. Meanwhile, the conference provided more than 30 hot topics covering all industry
chain.
The 2012 ISPE Annual Meeting will held in San Francisco in November
On Nov 11-14, 2012, the 2012 ISPE Annual Meeting will be held in San Francisco. The 2012 ISPE
Annual Meeting includes a four-day conference highlighting education sessions on the latest
information in technology innovation, application and best practices. Regulatory Sessions will engage
regulatory agencies from around the world in discussions with the industry, building consensus
around guidance, quality issues and technology application.
This year, ISPE offers a very interesting activity- Factory Tours. Sign up for the tours, attendees will
be available to visit the most leading pharmaceutical factory sites, such as Boehringer Ingelheim,
Genentech, UCSF 19A Neurosciences Project. You will be more deeply understood of high quality of
site design via the factory tours arranged by ISPE.
See more detailed information about The 2012 ISPE Annual Meeting
Choose your interested topics of ISPE trainings, win free training ticket!
ISPE is starting to plan the trainings in 2013. We are nowcalling for topics. In order to better
understand the need of industry, you are kindly invited to vote! Please vote your desired topics of
following selection. Your comments are important! (Only need your 1 min)
Some of lucky voters will get ISPE magazine. What's more, one complimentary ticket of ISPE
training will be given out. Don't hesitate and vote now! Survey URL:
http://www.surveymonkey.com/s/PBV7VNJ
Two ISPE Chinese Technical Guides to be published
With nearly 1 year preparation, Chinese version of “Commissioning & Qualification” and “Water and
steam systems” technical guide of ISPE baseline series will be published in the end of 2012.
Translated by ISPE technical committee members, ISPE would like to display an official Chinese
language version with the maintaining of original messaging.
The Commissioning and Qualification Baseline® Guide provides advice and guidance that may be
applied to all types of facilities, utilities, and equipment found in the healthcare industry. The Guide
has incorporated comments from industry representatives from all areas and disciplines, FDA Field
Investigators, and personnel from the FDA's Center for Drug Evaluation and Research (CDER).
The Water and Steam Systems (Second Edition) is the only comprehensive guidance of its kind
and aims to assist with the design, construction, operation, and maintenance of new water and steam
systems that meet current Good Manufacturing Practices (cGMPs) and comply with existing
regulations and related guidance.
New chapters covering microbiological considerations, such as biofilm formation, use of sanitizers,
sampling, testing, and control levels, as well as the overall impact of microbial considerations on unit
operations and finished water have been added.
These two Chinese version will be published by the end of 2012; each of the guides is CNY 350
(Membership price) Call 21-5108-1512 for purchasing.
ISPE new publication update
The ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems
The ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems provides
important insight into the design and use of pharmaceutical ozone sanitization systems, and is the
first industry Guidance Document to take a holistic view of these issues. The Guide provides an
overview of ozone sanitization systems. The Guide helps companies better understand what ozone
systems are, why they can be a safer, more efficient and more cost-effective way to sanitize
pharmaceutical water, and how they can be incorporated into both new and retrofitted facilities.
Visit here to see more details of this new Guide.
ISPE Good Practice Guide: Quality Laboratory Facilities
The Guide provides a step-by-step process that guides the reader through all phases of producing a
quality lab and all the factors that must be considered at each phase. Additionally, it can help lab
owners explain lab requirements and justify budget to senior management. The Guide is a valuable
tool for engineers, who can use the Guide’s contents to help their clients focus on the type of
information needed to successfully complete a project.
Visit here to see more details of this new Guide.
Free Downloading ISPE Technical Documents – member only
ISPE member now can enjoy more benefits! Recently ISPE China created a member-only webpage
to place more than 10 Chinese version technical documents for member to free download Most of
articles are selected from ISPE magazine- Pharmaceutical Engineering, Topics include: validation,
quality risk, C&Q, etc. These articles introduced the trend and development of pharmaceutical
industry, also has explained with the illustration of case studies. The topics can be found in the
articles such as “ new ISPE cleaning guideline, QbD, etc.
We would like to take opportunity to express our gratitude to the ISPE China technical committee,
wWthout their help, we can’t present these Chinese version articles to our members. We do believe
these resources will help Chinese professionals to learn more up-to-date knowledge and development
of industry. If you are ISPE member, click in to access free technical resources.
ISPE monthly gift-member only
On October, ISPE will offer member 3 gifts, such as assigned chapter free downloading of 2 technical
guides as well as a presentation about “Conducting Clinical Trials in India.
Gift 1: Introduction to the Quality Risk Management Process
From the ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and
Equipment (7th chapter)
Gift 2: Application of Quality Risk Management to Commissioning and Qualification
From the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification
(5th chapter)
Gift 3: Overcoming Regulatory and Logistical Hurdles When Conducting Clinical Trials in India
From the ISPE Online Learning Library
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The 2
ISPE Student Poster Competition has successfully held
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Recently, co-organized by ISPE and Sichuan University, the 2 ISPE Student Poster Competition has
ended up. 15 universities and 57 students are getting involved into this match. With nearly 4 months’
fierce competition, the top 3 prizes are selected. Congratulations to the winners.
The ISPE Student Poster Competition was initiated in 2011; it has attracted hundreds of students
majored in pharmaceutical. ISPE hopes to help students to enhance their operation and practice
ability. The next competition will be held in April 2013, save the date and go for it!