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Asia Pacific Affiliate News
The ISPE Singapore Affiliate organised a webinar session on Implementing the ASTM Standard for Verification (C&Q) on 24 September. Hosted by Zenith Technologies, Singapore, the pre-recorded webinar was led by Robert Steen who also moderated a discussion with attendees, after the webinar concluded. At the conclusion of the webinar Robert let a discussion on the content of the presentation.
The Affiliate also ran the webinar for Pfizer Asia Pacific Pte. Ltd. and for students at the SIM University of Singapore.
On 22 and 23 October, the Affiliated hosted ISPE’s Cleaning Validation Principles training course at Singapore Polytechnic Graduates Guild (SPGG). The course was conducted by Rob Walker, Principal, Rob Walker GMP Consultancy Ltd, chartered chemist and a Fellow of the Royal Society of Chemistry.
During the two day course, participants covered elements of a cleaning validation programme from start to finish, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology process, and establishment of scientific rationales acceptable to regulatory inspectors.
Rob Walker, Principal, Rob Walker GMP Consultancy Ltd., Chartered Chemist and Fellow of the Royal Society of Chemistry leads ISPE Singapore Affiliate’s training course on Cleaning Validation Principles
The ISPE Singapore Affiliate also held a very successful ISPE Student Symposium 2009 on 6 November, with close to 400 participants. The event was a platform to reach out to tertiary-level students and to adults who were interested in getting to know more about the biopharmaceutical industry.
Mr Timothy Marshall opened the symposium with an overview of his working experience and insights into the pharmaceutical industry. Speakers from well-known pharmaceutical companies such as GlaxoSmithKline, Lonza, Baxter Bioscience and Schering-Plough also gave an introduction about their organisations and how the organisations function.
The Singapore Economic Development Board (EDB) and Merck Sharp & Dohme (Singapore) Ltd. shared with attendees the opportunities and challenges that face the professionals in the pharmaceutical industry. Representatives from EDB, GlaxoSmithKline, Lonza and ISPE were present at exhibit booths to provide information for participants.
The ISPE Singapore Affiliate extends its gratitude to the Student Committee.
The Student Committee from left to right: Leow Guohao (vice-president), Evon Lim (PR and HR), Yap Shifeng (Treasurer), Tan Pei Ying (IT), Stephanie Tan (Secretary), Cassandra Cheang (President), Mr Lawrence Wei Khia Yap (ISPE Faculty Advisor) Ms Joycelyn Kwek (Industry Advisor)
The Japan Affiliate’s yearly US plant tour took place from 2–6 November on the West Coast. The tour was organised and led by its team of five from the Board and membership, who had solicited the goodwill of several potential host companies in the months leading up to departure from Japan.
The 19 participants from pharmaceutical manufacturers, engineering companies, and vendors arrived in Seattle to visit Amgen, followed by tours to Genentech and Bayer in San Francisco. The group was also invited to join the “Commuter Conference,” which was organised by the San Francisco/Bay Area Chapter. The visit also included a tour arranged by host Amgen of its facilities in Fremont for all the conference attendees. The group concluded the plant tours with a visit to Baxter in Los Angeles, before transferring to San Diego for the 2009 ISPE Annual Meeting.
Plant tour at Genentech in San Francisco
The Affiliate’s 2009 US Plant Tour Organising Committee would like to thank the respective personnel at each of the plants for their hospitality and generosity, which helped made the week very memorable and fruitful for the participants.
On 13 November, the Pharmaceutical Facilities/Equipment Project Management Seminar — an engineering management (EM) seminar — was held at Tower Hall Funabori in Tokyo, Japan. Organised by the EM COP, which is unique to the Japan Affiliate and led by Takashi Hoshino, the event attracted close to 100 registrants. The highly popular event was oversubscribed and many event registrants were turned away because of space constraints. However, this has motivated the Japan Affiliate to look into organising another seminar in 2010.
Participants enjoying a vibrant and educational session at the EM Seminar
Since its founding in 2006, the EM COP has conducted intensive studies aimed at establishing suitable contract forms and associated technical/commercial specifications for the Japanese market. Its aim is to present interim output for both the purchaser side and the contractor side.
Meanwhile, the Maintenance COP has been busy with the translation of the ISPE Good Practice Guide: Maintenance into the Japanese language as part of the Affiliate’s continuing tradition of technical documents translation for distribution in Japan.
For more information on the Japan Affiliate and its activities, please visit www.ISPE.org or contact Office Manager Natsumi Sahara at ISPEfirstname.lastname@example.org or by telephone at +81-3-3818-6737. You can also contact Shigeru Nakamura, Head of Secretariat, via email at email@example.com.
With the theme of “Facilitating Internationalization of China Pharmaceutical Industry,” the ISPE-CCPIE China Conference 2009 was successfully held in Shanghai from 26-28 October with approximately 400 participants in attendance.
The officers from SFDA and US FDA shared their insights about the new China GMP and FDA/EU GMP. After the fantastic keynote presentations, six industry tracks with tailored addresses of technical and practical issues were held concurrently on the first two days of the conference. The topics included HVAC and environmental control, GAMP, cleaning validation, pharmaceutical water, application of C&Q, and sterile drug manufacturing facilities.
On the last day of the conference, the delegates paid a visit to seven state-of-art pharmaceutical facilities in Shanghai and Suzhou. The plant tours are an integral part of the conference and are always very welcome by both Chinese and foreign participants.
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