Sept-Oct, 2011
In this issue:
-ISPE-CCPIC China Conference 2011: Register Now! Last days for your enrolment!
-ISPE training topics in 2012
-Chinese version of “Baseline Guide Volume 2: OSD” and “Baseline Guide Volume 3: Sterilend
Manufacturing Facilities (2 version)” are about to publish now
-ISPE new website will be alive
-ISPE Online Learning area- best channel to increase knowledge
-ISPE monthly gift for October
-ISPE China poster competition successfully held
-2011 ISPE facility design competition starts to register
-COPs offline activity connected professionals in Beijing
-ISPE Committee introduction - Membership Development Committee
ISPE-CCPIC China Conference 2011: Register Now! Last days for your enrolment!
ISPE-CCPIE China Conference 2011 will be held on October 25 -28 in Shanghai, InterContinental
Shanghai Expo-Shanghai, China. As a grand gathering of Chinese pharmaceutical elites, it will be
themed as "The New Age in the Chinese Pharmaceutical Industry – come and get world class best
practice.” The SFDA, FDA, WHO officials, industry leading experts will be invited to bring high-quality
keynote speeches.
Featured keynote speech:
-New China GMP Regulatory - SFDA, Department of Drug Safety & Inspection
-How to conduct and prepare GMP inspection under Pharmaceutical Quality System :European
Regulatory Affairs Advisor, Bryan Wright
-Prequalification of Medicines Programme as a WHO tool to upgrade manufacturing standards WHO
official: Milan Smid
-New China GMP Compliance Implementation and Current Status: SFDA official, Zhang Aiping
-China Pharmaceutical Business Overview: Director, PricewaterhouseCoopers, Xujia
Special Segment of Conference
Delegates who participate for whole conference will have opportunity to win the free ticket for ISPE
2012 conference. For full package ISPE members, they can take part in lucky draw session, members
may get free ticket and 50% vouchers for one ISPE training course in 2012, as well as one ISPE
technical guide: “Chinese version of “Baseline Guide Volume 2: OSD” and “Baseline Guide Volume 3:
Sterile Manufacturing Facilities (2nd version)”. Also only ISPE members will be given away PE
magazine.
Beside, conference will have a job posting board. If your company would like to post job vacancy and
hope to display on the conference, please feel free to prepare job vacancy and you can post on the
board we prepare. Also, you can send it to china@ispe.org before the conference; we will help to post
on the conference.
Click here to see speaker information| feature topics
Click here to register the ISPE-CCPIE conference, last days for your enrolment!
ISPE training topics (TBD) in 2012
In 2011, there are several trainings held in China and has attracted many professionals in
pharmaceuticals industry. Now training topics in 2012 has been launched, for more detail please visit
our website: www.ispe-event.org.cn
Curriculum for ISPE Training Courses 2012(TBD)
Course name
Process Validation in Biotechnology Manufacturing
Biotechnology
Applying the Biopharmaceutical Manufacturing Facilities Baseline® Guide Principles
GMP fundamentals for the Biotechnology Industry
Cleaning
Cleaning Validation
Commissioning
and Qualification
Application of Commissioning and Qualification: Applying the Commissioning and
Facilities
Qualification Baseline Guide Principles
Sterile Drug Manufacturing Facilities: Applying ISPE Baseline® Guide and FDA
Guidance Principles to Design and Operation
Practical Application of Computerized Systems Compliance: Applying the GAMP5®
GAMP
Guide: A Risk-based Approach to Compliant GxP Computerized Systems
GMPs
GMP Auditing for the Pharmaceutical Industry
HVAC
HVAC for Pharmaceutical Facilities
Manufacturing
Managing the Risk of Cross Contamination: Applying the Risk-MaPP Baseline® Guide
Chinese version of “Baseline Guide Volume 2: OSD” and “Baseline Guide Volume 3: Sterile
nd
Manufacturing Facilities (2 version)” are about to publish now
With the solid assistance of ISPE volunteers, Chinese version of “Baseline Guide Volume 2: 2nd
Edition: Oral Solid Dosage Forms” and “Baseline Guide Volume 3: Sterile Manufacturing Facilities”
nd
(2 version) now are about to publish. The price for each technical guide is 350 Yuan respectively.
nd
The reason to publish Chinese version of OSD and Sterile Manufacturing Facilities (2
version)
After discussion with ISPE technical committee, everybody agrees that OSD and Sterile
nd
Manufacturing Facilities (2 version) are the most popular technical guide among the professionals.
Regarding to OSD, as the most widely produced dosage formulation, OSD baseline provides a good
technical guideline for China pharmaceutical manufacturers to reach the international level. About
nd
Sterile Manufacturing Facilities(2 version), ISPE Baseline Pharmaceutical Engineering Guides for
new and renovated facilities created in partnership with the US Food and Drug Administration (FDA),
ISPE’s Baseline Guides offer practical answers to the complex, dynamic challenges facing facility
designers today.
Meanwhile, English e-version Sterile Manufacturing Facilities (2nd version) also has been launched
and paper version will be published in the end of 2011.
Now it’s time to reserve!
The launch ceremony of the Chinese version of OSD and Sterile Manufacturing Facilities (2nd version)
will be held in ISPE conference you could buy new books onsite directly. Chinese version guides are
dedicated to press close to the professionals and help them to enhance their business. Please fill the
purchase form and send to china@ispe.org if you would like to purchase Chinese version OSD and
Sterile Manufacturing Facilities (2nd version)
ISPE new website will be alive
ISPE new website will be officially online on Oct. The new website will be displaying in a simplified
style and more functional. The section, such as technical article, COPs, career solutions are easily
touched and you can visit all affiliates website via homepage of ISPE new website.
ISPE China new website will be launching at the same time. By visiting ISPE China new website, for
enjoying following features:
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Introduction on membership benefit
Webinar courses
Online discussion forum
ISPE local and regional trainings and events
ISPE Online Learning area- best channel to increase knowledge
ISPE’s online learning offerings include live and on-demand webinars, webcasts, and online courses
to help you expand your skills and knowledge from the comfort of your desk. With such an extensive
library of online learning options, you’re sure to find something that meets your needs. Online learning
provided many aspects in pharmaceutical industry, such as API, Biotechnology, commission and
qualification, etc. Meanwhile, CPIP training courses are provided as well.
ISPE expects to combine the internet and delivery of professional knowledge and to furnish the best
way for learning and communication to the professionals. Click here to start your learning.
ISPE monthly gift for October
For this month, ISPE would like to provide members for English translation of the SFDA Guideline
revision as the monthly gift. This 115-page document contains a paragraph-by-paragraph English
translation of Annex 1 - Annex 5 of the SFDA Guidelines’ original Chinese text. Creating and
providing this document is just one of the many ways ISPE is connecting a world of pharmaceutical
knowledge. Download your copy now!
If you are an ISPE member, please download here: Good Manufacturing Practice (2010 Revision)
(Free to members through 31 October 2011)
ISPE China poster competition successfully held
The first-ever Poster Competition in ISPE China has been successfully held in the end of Aug. Finally,
the contestant from Sichuan University, Wangwei, has won the champion.
The Post Competition has been started since in June, more than 40 posters have been posted and
the first 3 winners have been finalized with final review by judge. All the contestants expressed that
ISPE furnished a good platform for student to put their study into practises.
2011 ISPE facility design competition starts to register
To better promote the development of education in major of pharmaceutical, also to enhance the
ability on operation and designing for college students, governmental committees for pharmaceutical
major would like to organize a facility design competition with ISPE and Sichuan University.
Students majored in machinery, construction, automation are welcomed to participate this competition.
For more details please feel free to view the announcement. If you would like to get involved into this
competition, please download the registration form and send to chengqiang@scu.edu.cn
COPs offline activity connected professionals in Beijing
COPs offline activity was held in Sept and more than 10 professionals got involved in this meeting.
For this activity, the professionals Zhu Liming and Meng Xiangfei were invited to be the speakers and
both of them introduced about LIMS, QMS,etc. Later, delegates shared their insights with speakers
regarding to topics of management of quality system, validation,etc.
Finally, all participants expressed that they shared knowledge and get to know others in this industry
and would like to take part in more activities with ISPE.
ISPE Committee introduction - Membership Development Committee
In this issue, we would like introduce the updated committee-Membership Development Committee.
This committee formed in this August, transformed from the previous Promotion Committee. The main
role of MDC plans to recruit more members with sales and marketing background. The Chair of this
committee is Ray Liu from Austar. Current members include Ray Liu, Peter Ma, Jiang Yang, Eric
Meng, Shannon Wang, Qi Ying,etc.
This committee will be mainly focused on membership development, retention and improvement of
membership services. Currently the committee is in the process of defining its key objectives and
action plan for 2012.