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Happy New Year! It's been a pleasure to serve as affiliate President and eventful, literally as I recently moved to Japan. I'll miss the AGM next week, but wish to take this opportunity to thank all who contributed to our events and activities last year. Some highlights:
- Over 20 events held, an increase from 9 in 2015 and 14 in 2016!
- New quarterly networking with 'Thirsty Thursdays' on the first Thursday of each quarter
- Successful launch of APAC Regional conference on GAMP Data Integrity with US HQ
- Singapore represented at the US Annual Meeting and affiliate meetings in Indonesia, Thailand and Japan
- Joint affiliate-affiliate workshops in Jakarta and Bangkok
- Revived and active Student Committee with extended YGEN Challenge and 3 site tours
In another new initiative, look out for the PharmBio (formerly BioTech) Directory which features ISPE and and expanded section on manufacturing, to be published in February.
No doubt, there are more exciting developments to come and I encourage you to get involved and make the most of these opportunities. Wishing you all a great year ahead and a warm welcome to the new Executive Committee for 2018!
Geoff Brown
President 2016-2017, ISPE Singapore Affiliate
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From ISPE Singapore affiliate's longest serving Board of Directors member:
Lee Hong Ping
Executive Committee member, past Assistant Secretary, Vice-President, Treasurer, Secretary & Membership Chair.
ISPE Singapore Affiliate - 18 years and going strong....
The ISPE Singapore Affiliate started in June 2000 with the support from the Singapore Economic Development Board (EDB). Its mission is to develop an active events calendar and provide education and training services in Singapore and South East Asia for pharmaceuticals manufacturing and GMP compliance. The 1st ISPE Singapore Affiliate Executive Committee was formed by a few volunteers and leaders from GlaxoSmithKline, Schering-Plough, Sanofi, engineering service providers and local pharmaceutical manufacturers.
I have been serving in the Singapore Affiliate Executive Committee after being elected as the Assistant Secretary in 2001. Since then, I have served on the ISPE Singapore Affiliate Board of Directors as Vice-President, Treasurer, Secretary and Membership Chair.
In the beginning years, Singapore as a whole managed to attract many foreign direct investments as a commitment to participate and grow the Singapore Biomedical Eco-system. The ISPE Singapore Affiliate also helped to provide the leadership and drive for cGMP education and training for the Asia Pacific countries. In 2007, ISPE Singapore Affiliate was bestowed the Affiliate of Year Award by ISPE HQ.
In October 2017, I attended for the first time the ISPE Annual Meeting & Conference in San Diego, USA. It was definitely a good opportunity for me to meet with all the ISPE HQ leaders and staff whom I have corresponded with for many years. Meeting and interacting with all the ISPE members worldwide, enabled very good exchanges of ideas and lessons learnt. It was also an icing on the cake when the Singapore Affiliate was presented with the "Affiliate and Chapter Excellence Award for Innovation and Society Support".
I hope to continue to serve in the ISPE Affiliate Board of Directors and contribute to the growth and advancement of the biomedical industry in Singapore for many more years to come.
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George Kaliviotis
Senior Operations Start-Up Manager, Cell Culture & Central Services
AbbVie Operations Singapore Pte Ltd
ISPE SG: You're leading the cell culture & central services manufacturing operation in AbbVie's state of the art facility. How did you arrive at your current role and what do you enjoy most about it?
GK: I have been with AbbVie for almost 10 years, working at our biotech facility in Worcester, Massachusetts. In those 10 years, I held a variety of diverse roles with a focus on biotechnology manufacturing operations. When AbbVie announced the investment in Asia, I immediately talked to our Senior Management about potential opportunities there and how I could contribute to the start-up. It worked out and two years have already gone by quickly. What I enjoy about my current role is the varied activities to deal with during the startup of the facility, coaching and training of our new teams, and setting up the manufacturing facility to prepare for full operation mode. I can say that there is never a dull day especially in startup mode!!!
ISPE SG: With over 17 years in this industry, this is your first overseas posting. What difference have you experienced in your role and industry, working in Asia?
GK: For over 17 years now I can say that I have seen and dealt with a lot of challenges, which helps me in my current role. One of the biggest adjustments I had to make was adapting to the local culture and working style. It was a bit of a challenge to get people to speak up and recognize that all input is essential regardless of one's role or the organization's hirarchy. Being more remote from North America or Europe, some of the technical and vendor support for equipment and technology is also more challenging with time and distance. This will ease as the industry grows and develops in Asia.
ISPE SG: What do you consider your team's biggest challenge in 2018?
GK: Now that our plant is up and running, we are focused on the execution of our process validation runs, and ensuring that all our procedures are in place and ready for the upcoming regulatory inspections. As we look forward to additional throughput we need to focus on continuous manufacturing improvements to be more efficient, and execute against our staffing plans.
ISPE SG: How does ISPE and/or our Annual meeting/events help you in your role?
GK: ISPE events are a great way to collaborate with people from the industry and discuss ways that can make our industry better. Our job is to bring life changing medicines to our patients faster so that they have better quality of life. Sharing these practices and having the industry support is important.
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See what our student chapter was up to in 2017
An article by Wendy Han, President, ISPE Singapore Student Committee
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My Experience at ISPE Annual Meeting,
San Diego, USA
A beautiful professional and personal learning experience to lead the Pharma research and Industry.
Hear from our 2017 Student Poster Competition winner, Himanshu Kathuria, National University of Singapore on his prize trip!
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ISPE Singapore AGM & Dinner
18 Jan 2018 | 6-9pm
Genting Hotel, Sky Lounge, Jurong
It's not too late to nominate members for this year's committee! Review 2017, vote and relax with dinner and drinks
Supporting Event Listing
Cyber Security for Quality Assurance Professionals 101 (organized by Silver Bullet Security)
22-24 Jan 2018
Singapore Suntec Convention and Exhibition Centre
Attend three days of in depth training on cyber security and learn its importance to data integrity.
Case Study of a Sterile Boundary
2 Feb 2018 | 5.30-7.00pm
Jurong (TBC)
Biological contaminations are difficult to troubleshoot. There are significant variables that make it tough to take a step by step, systematic approach to correct the issues. We will review a steaming operation which compromised the sterile boundary, and review the changes implemented to improve the cycle and quality.
About the speaker
Sponsored by:
Supporting Event Listing
Risk Based Process/Cleaning Validation Training
9 Feb 2018 | 1-5pm
FREE! Open to Young Professionals and those who are new to the industry
Limited Places; Register here
Supporting Event Listing
Lean Training - Lean Awareness & Lean Simulation
23 Feb 2018 | 1-5pm
Location: TBC
FREE! Open to Young Professionals and those who are new to the industry
Challenges and Advances in Cleaning Ultrafiltration Membranes used in Bioprocessing
TBC Feb/Mar 2018
Genting Resort Jurong
Facilitated by:
Supporting Event Listing
Phar-East 2018
1-2 March 2018
Suntec Convention & Exhibition Centre
Asia's pharma & biotech festival, showcasing the very best in Asian pharma excellence. It's where big pharma and biotech, regulators and payers, solution providers and technology leaders all come together to build new relationships, cement existing partnerships and chart the path forward in Asia's life sciences industry.
ISPE Singapore Quiz Night 2018
25 April 2018 | 6.30 - 9.30pm
Twenty15@Big Box, Jurong
Don't miss our most popular annual social event of the year!
Thirsty Thursday with ISPE!
5 July 2018 | 6.30 - 8.30pm
Unwind, meet old and make new friends conveniently in Jurong East! Finger food & first round on the house, thereafter 1 for 1 Happy Hour. Bring a friend from or if you're full time staff from bio/pharma manufacturing facility, enjoy bonus drinks!
ISPE Singapore Conference &
Exhibition
29-31 August 2018
Mark your calendars for our annual event, packed with learning, case study experience and informative exhibition.
Limited exhibit spaces & sponsorship available,
Contact us if you'd like to include your
event here. (Postings are vetted according to ISPE guidelines on commercial content and subject to approval by the committee.)
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ISPE Thailand Workshops:
12-13 Feb 2018, Ambassador Hotel, Bangkok, Thailand
1. Applied Risk Management for Commissioning & Qualification
2. Changes to the PIC/s GMP Guidance on the Manufacture of Sterile Medicines
(Annex 1)
Member: 2,000 Baht per day
Non-member: 3,000 Baht per day
ISPE Indonesia Annual Meeting
8-9 May 2018
, Jakarta, Indonesia
ISPE Thailand Annual Meeting
17-18 Jul 2018,
Bangkok, Thailand
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Would you like to share some interesting news, articles or highlight any tips or advice for other members?
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Highlights from the ISPE 2017 Asia Pacific GAMP Data Integrity Conference, from a delegate's prespective
by David Bartlett,
No deviation
Do you use traditional paper records to hold your data? Or do you record to DVD and hard drives?
More importantly, does it matter?
Regardless of how your data is recorded -- paper or PDF - the same rules for data integrity apply. At the ISPE Singapore 2017 Data Integrity Conference held on 13 & 14 Nov 2017, industry leaders and regulators gave their stance on the use of electronic records in pharmaceutical manufacturing.
Highlights from the conference included presentations by FDA and WHO auditors, and panel discussions about data integrity in an electronic world; summaries can be found at the following links:
Questions From the Audience: "How do you start Improving Quality Culture?"
Questions From the Audience: "Is GAMP5 still relevant in 2017?"
Want to Trust Your Decision? Trust Your Data First.
What does the FDA say about Electronic Records?
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Cleaning Validation Workshops (Regional)
16-19 Oct 2017
Organised with Thai and Indonesia affiliates, our first 2-day training on Cleaning Validation saw over 150 attendees. Thanks to sponsors No deviation, Repassa and Steris for making this possible.
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PAT CoP Session
3 Nov 2017
Dr Oh Ching Mien and Dr Chew Wee held a dialogue session on Regulatory Aspects of QbD and PAT
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ISPE 2017 Asia Pacific GAMP Data Integrity Conference
13-14 Nov 2017
Close to 150 participants convened at NTU Alumni Club for this regional launch event, with speakers including FDA, Eli Lilly, Merck Biopharma, Lachman Consultants, Novartis, Abbvie & GSK.
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ISPE Soccer Tournament 2017
24 Nov 2017
5 teams and 34 players competed at the newly renovated Golazo Futsal ground, with Team Novartis lifting the winners' trophy. Congrats and thanks to our sponsors: 1Supplier, No deviation, PM Group, Repassa, Steris and all who took part!
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Thirsty Thursday
4 Jan 2018
We kicked off the year with close to 30 gathering to catch up over drinks and snacks. Look forward to our annual Quiz night in April, with Thirsty Thursdays 2018 on 5 July and 4 October.
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Your feedback and suggestions are most welcome as we strive to provide you with membership and industry news updates.
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Contact Us
ISPE Singapore Affiliate
Ph +65 6826 1105
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