In this issue:
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In this issue: ISPE China Annual Conference 2012 Counting Down- Last chance to register! ISPE will place booth on the conference ISPE calls for Subject Matter Experts for China Trainings Welcome to ISPE booth at CIPM ISPE monthly gift- sterile presentation ISPE COP turns to member-only COP offline event held on March in Tianjin ISPE New Guide Release: Comparator Management ISPE committee introduction- Training committee ISPE China Annual Conference 2012 Counting Down- Last chance to register! Don’t miss the last chance to sign up the top notch industry summit and block your calendar on April 16-17, 2012, for ISPE China annual conference. You will be thrilled to meet with the world’s leading pharmacy company leaders’ well as regulators from USFDA, SFDA, PIC/S and MHRA. Three breakdown sessions features more than 30 speakers on topics of “Product & Process”, “Manufacture & Quality Management” and “Facility Design, Refurbishment and Operation Management’. Speaker introduction (partially): Helena Baiao – Chair, PIC/S Ilisa B.G.Bernsein – Director (Acting), Office of Compliance of CDER, USFDA Helena Baiao – Chair, PIC/S Gordon Muirheak – Vice President and Head of the New Product Introduction group GSK; Co-Chair Fangdong Yin – PhD, Research Advisor, Eli Lilly and Company, Indianapolis, Indiana, USA Jun Ouyang Ph.D - Senior Manager and CMC Team Leader at Technical Regulatory of Genentech Roger Nosal – Vice President of Global Chemistry at Pfizer Bob Tribe - former PIC/S Chairman, and former Chief GMP Auditor for TGA Wu Jun - SFDA Training Centre visiting Professor, PDA, ISPE registered members Richard O’Keeffe - Director of International Quality at Amgen Inc. Jifeng Lei - Founder and CEO of Shanghai Anbison Lab. Co. Ltd. View more speakers Highlight topics (partially): Session A: Product & Process Provisions for Submitting a Quality by Design Regulatory Application – Industry Perspective of Regulatory Review & Inspection Experience Technology Transfer Handling Regulatory GMP Inspections Session B: Manufacture & Quality Management Sustainable GMP Implementation – Proactive Approach Aseptic Process Validation Implementing QRM as a New Quality System – An Asia & International Perspective Session C: Facility design, refurbishment and operational management Risk management in facility & equipment design based on products Characteristics Facility design, refurbishment and operational management: State of the art packaging facility design following LEAN production principles Commissioning & Qualification Services Integrated into the Pharmaceutical Project Lifecycle After the each session, there is a panel discussion that is a platform for each participant can discuss with the regulators from the SFDA, USFDA, PIC/S and work side-by-side with the professional in the industry. Know more topics Registered companies (partially): So far, there are more than 70 pharmaceutical companies has been confirmed to attend ISPE China annual conference 2012, and some of them are top multi-national pharmaceutical companies, including: -Bayer Healthcare Company Limited, Qidong Branch -GlaxoSmithKline (GSK) -Shanghai Roche Pharmaceuticals Ltd. -Tianjin TASLY Group Co.,Ltd. -Lilly Suzhou Pharmaceutical Co., Ltd. -Siemens Industry Software (Shanghai) Co., Ltd. -Pfizer -NNE Pharmaplan -Yangtze River Pharmaceutical group View more registered companies ISPE will place booth on the conference During the event, ISPE will place a booth near the registration area, to display ISPE high value technical resource: ISPE knowledge center: You have chance to read ISPE technical guides onsite and order directly! A series of ISPE guides covered the most prestigious and valuable industry knowledge. ASK ISPE: On the booth, you can ask questions about pharmaceutical industry. Professionals will reply and give answers on ISPE pharmaceutical BBS: http://blog.ispe.org/forums/. Besides, you can register as a member on ISPE BBS on the booth. ISPE prepared some gift to encourage registers. ISPE membership application You can apply as an ISPE member on our booth! ISPE member can enjoy a series of member benefit, such as purchase technical guide by discount price, take part in training and other event which ISPE organized. ISPE job board If your company would like to hire professionals or individual hopes to look for job opens, you can bring job description/ personal resume and it can be shown on ISPE job board that we prepared. Now we are collecting job vacancy information, if you have job opens, please feel free to send to eyan@ispe.org. ISPE calls for Subject Matter Experts for China Trainings ISPE is calling for Subject Matter Expert (SMEs) and volunteers (main task is to translate technical materials). Topics include: -Application of Commissioning and Qualification: Applying the Commissioning and Qualification Baseline Guide Principles -Practical Application of Computerized Systems Compliance: Applying the GAMP5® Guide: A Riskbased Approach to Compliant GxP Computerized Systems -Process Validation in Biotechnology Manufacturing -Biopharmaceutical Manufacturing Facilities: Applying the Biopharmaceutical Manufacturing Facilities Baseline Guide Principles -Process Validation in Biotechnology Manufacturing -Sterile Drug Manufacturing Facilities: Applying ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation -Cleaning Validation Principles -HVAC for Pharmaceutical Facilities -Pharmaceutical Water Systems If you have relevant experience, just don’t hesitate to contact us and join us as a volunteer. You can apply SMEs and volunteer via following channel: send email to chinaevent@ispe.org or dial to 86-215108-1590. Find the latest training plan via http://www.ispe-event.org.cn/ Welcome to ISPE booth at CIPM th On May 8 2012, ISPE will attend CIPM exhibition in Shenyang, Liaoning province. As an invited organization, ISPE will kindly invite pharmaceutical professionals to take part in forum section on CIPM. Michael Lee, senior leader from TDW Pharma Company, Lena Wang, marketing director from Austar and Gao Juan, chief science consultant of Shanghai Pharma Group will be invited as speaker to represent ISPE to have speech on the CIPM. Their topics are “Sterile transfer application after launch the GMP, sterile production technical validation. 3 Speakers are influencing professionals among the pharmaceutical industry. We are looking forward visiting from the audience. Meanwhile, ISPE will have one booth in CIPM exhibition. We will display ISPE English version technical guides as well as Chinese version ones, membership brochure and other materials on our booth. Also audience will freely have a chance to receive ISPE official magazine- Pharmaceutical Engineering. Our booth no. is E1-V30. Take some to visit our booth if you are in CIPM. ISPE monthly gift- sterile presentation At last month's Global Evolution of Aseptic Processing conference, sterile expert Mark Von Stwolinski's keynote speech gave delegates a rare inside look at one of ISPE's most influential documents, the ISPE Baseline® Guide: Sterile Manufacturing Facilities (Second Edition). Don't miss this limited-time opportunity to view the presentation, which is usually available only to conference delegates. Watch the presentation to: Get an inside perspective on the newest edition of the ISPE Sterile Guide, straight from one of the Guide Authors Discover key updates on Room Environment Systems, Capping Rooms and Aseptic Processing Learn the 3 approaches for achieving environmental contamination control Chinese version of ISPE Baseline® Guide: Sterile Manufacturing Facilities (Second Edition) has also launched！Know more about this book. ISPE COP turns to member-only As of today, 14 March 2012, ISPE Communities of Practice (COPs) are a Members-only benefit. There is now an announcement on the ISPE Home Page as well as a message on the COP home page about this conversion. When Non-ISPE Members try to access Member-only content, which now includes the COP Discussions and E-Letter content, they are directed to a landing page with a message that this content is available to Members only, information about the benefits of becoming a Member and a link to the page where they can join. COP offline event held on March in Tianjin In the afternoon of March 17th, ISPE held a COP offline event in Tianjin. There are around 60 attendees who took part in the event, which includes professionals and faculties in universities. Speakers for this event are Xie Jingjun from NNE Pharmaplan and Sun Xiaobing, Zhao Yunxia from Pharm-tech Company, the topic covers “Risk based pharmaceutical facility qualification system establishment” and “Facility Design”. COP offline event is a platform for pharmaceutical professionals and will hold in different cities. If you don’t have availability to attend, you can also participate in our ISPE official BBS: ISPE pharmaceutical BBS: http://blog.ispe.org/forums/. ISPE New Guide Release: Comparator Management ISPE now launched a new technical guide- Comparator Management. This new ISPE Guide is the pharmaceutical industry’s first-ever resource for comparator processes. The Guide is a central reference source that establishes strategic and tactical considerations related to comparator sourcing, including how to set up a good sourcing team. The Guide discusses good practices for blinding and releasing a comparator for use. If your company performs comparator trials, you must buy this Guide! Know more about book. ISPE committee introduction- Training committee In this issue, we would like to introduce the ISPE China Training Committee. There are 10 members in training committee. Training committee’s main task is to work with China office to develop training plan, support the course localization to meet local needs better, identify and develop ISPE local instructors, etc. Later, training committee will work together with ISPE office to identify appropriate SMEs (Subject Matter Experts), discuss course customization with ISPE course developer, Identify appropriate facilitator and support course materials translation and review, etc.
