"Change is inevitable. Change is constant."
- Benjamin Disraeli
As the year progresses, we find ourselves continuously keeping up with changes, whether personal, organisational, personnel, process, systems and so on. How we adapt to and learn from change, which is a constant, will influence our 'success', however we measure this.
We hope that our activities can help you along your professional journey and look forward to meeting you at our events. As we strive towards continuous improvement, we invite and welcome your feedback and suggestions!
Best regards,
your ISPE Singapore Affiliate
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ISPE Singapore President 2018/2019
I am pleased and honored to begin my term as President of the ISPE Singapore Affiliate. Congratulations to all our new Executive Committee Members. The first few months as President has been gratifying because of the extraordinary Executive Committee. Their enormous energy and passion actively promoting ISPE throughout the APAC region is exemplary of the organization's vision.
As you see already this year, our Executive Committee is continually active in many ways, through the student chapter and our new series entitled "Technical Tuesdays". I encourage you to visit our website to explore the range and quality of the workshops, events and future training available and to share this information on to members and non-members of ISPE.
As we prepare for our upcoming conference in August, I want to acknowledge the terrific work done by our Conference Planning Committee with our organising partner, IBC Asia. Many hours, planning and dedication has been put into development of the various tracks to meet our Industry needs. As Q1 is coming to an end, I would like our focus to increase membership for 2018 and promote our Affiliate events. For the long term, we should continue to help develop, build relationships and expand our reach with other APAC countries and ISPE affiliates. Let's grow the momentum off of Q1!!!
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Shan Shan Liu
Vice President, ISPE Singapore & Senior Technical Expert, NTO Global Engineering
ISPE SG: You've held various roles in projects in the region and internationally. What would you consider the key take-aways, which have helped you in your career so far?
SS: I've been grateful for all the opportunities provided to me, indeed equipped me with various knowledge and experiences, i.e. process, CQV, automation, project management, even business development. Hence I could view the project from different perspectives and coordinate with different functions. It's been enjoyable working with teams from diverse backgrounds and in different countries. It did open my eyes greatly. I constantly find the people I work/worked with are inspirational, with loads of ideas coming out of our discussion or even debate.
ISPE SG: What has been your greatest professional challenge and how did you overcome it?
SS: As a process engineer, there's huge potential for many different roles for self-development and various systems/process you can work on. That also means we need to, constantly, learn new process, skills, and technologies. I still remember the first time I worked on an OSD facility, or the first time I entered a facility to execute validation tests. There's no other way but hard work. I do have a secret though, which is communication, to learn from people. People from different functions, SME in the area, and equipment supplier who understand their system best.
ISPE SG: As ISPE Singapore affiliate's VP, what is your goal in 2018?
SS: For 2018, my vision is to grow our affiliate stronger technically, hence we initiated 'Technical Tuesday' which has so far received very positive feedback and interest. The events and our annual conference are very well planned throughout the year on various interesting and practical topics. Also we'd like to grow ourselves as the leader in the region, and be more recognized globally.
ISPE SG: What would you like to share with our readers here?
SS: I'd very much like to share that our Singapore affiliate is very determined to build our society and organization to help this industry to grow, develop a network for sharing knowledge and best practices, establish guidelines to follow, encourage new technology and innovation, and assist people with career development.
Shan Shan recently attended ISPE Europe's annual meeting on behalf of ISPE Singapore in Rome. Read about it here.
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Highlights from "Managing Your FDA Inspection: Before, During and After"
Presented by Casper E. Uldriks, Former Associate Center Director of FDA's CDRH
Attended by Carissa Choh, Honorary Secretary, ISPE Singapore
For most in the pharmaceutical industry, an FDA (Food and Drug Administration) inspection is
regarded as THE audit to pass and companies spend much time and efforts in their preparation leading up to the inspection. In fact, an attendee flew from Europe to Singapore just for this 2-day seminar, to prepare for her company's impending audit by the FDA. Glad to say that this event was quite worth the trip.
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Cyber Security for Quality Assurance Professionals 101
(organized by Silver Bullet Security)
Attended by Dave Bartlett, Executive Committee Member.
Catch up on what you missed here
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M+W Office, 16 International Business Park
17 Apr 2018 | 6-7.00pm
Sterilization - Process Vs Load
Surface Decontamination with H2O2
(sign up here)
ISPE Singapore Quiz Night 2018
25 April 2018 | 6.30 - 9.30pm
Twenty15@Big Box, Jurong
It's not too late to sign up for our biggest social event of the year! Test your knowledge of trivia and technical questions with our new Quizmaster.
Reviewing Electronic Data & Metadata,
such as Audit Trails
6 June 2018, 6-8pm
InterContinental Hotel Singapore
Led by Monica Cahilly, this 90-minute presentation, followed by 30 minutes for Q&A, provides an overview of the GXP requirements for review of original records, including source electronic records and meaningful "metadata".
*EXCLUSIVE* Places are Limited and priority will be for Members and on a first-come-first-served basis. Reserve your place now for this special evening!
Click here to sign up
Plus: (Supporting Event Listing)
All ISPE members and supporters will receive a 25% discount off standard rates for any of the above GMQA workshops. To obtain the ISPE-Singapore discount, please enter promo code ISPE-SG when checking out on the
www.greenmountainQA.com/workshops website.
YGEN Challenge
9 June 2018, 9am-6pm
Singapore Institute of Technology
Organised by students for students, this event will be a sharing cum presentation competition style event, revolving around a predetermined case and how to tackle it with different aspects of pharmaceutical engineering. Contact
sgispesc@gmail.com
for details.
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
This year's programme will be finalised by May! Maximise networking and learning with more regulators, industry case studies, subject matter experts and exhibitors than ever.
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 Indonesia Annual Meeting
8-9 May 2018
, Jakarta, Indonesia
Click
here for details and sign up
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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Convenient Point-of-Use/Sampling Systems for Pharmaceutical Applications
Water-for-injection (WFI) loops in pharmaceutical facilities are run at temperatures of 80 -85
°
C. The high temperature presents challenges as the water is being utilized. Use points for sampling, sinks, and vessel filling can pose a safety hazard to employees if the water remains at high temperature. It may also be far above the temperature required for analytical instruments used to monitor flow or WFI purity.
Heat exchangers have been commonly used to cool WFI to acceptable temperature at use points. Allegheny Bradford Corporation provides enclosed fully automated point-of-use/sampling systems that are safe and easy to operate and clean. These include valves and piping required for operation. The figure below illustrates such a system with the cabinet door open to show components.
A pitot tube and valves route hot WFI continuously through the heat exchanger, maintaining system sterility. When a sample or draw is needed, valves reverse the WFI flow through the heat exchanger. Utility valves open to provide coolant to the exchanger, cooling the WFI to a safe and monitorable temperature. Manually operated systems are also available.
Sponsored by:
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ISPE Singapore AGM & Dinner
18 Jan 2018
Close to 70 attended our AGM and election of the new Executive Committee. Thanks to the outgoing and welcome to the new team!
Click here for the 2018 Committee.
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Case Study of a Sterile Boundary
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SOP review session with students from the Singapore Institute of Technology
30 students signed up for this first of a kind SOP Review Session facilitated by our Executive Committee. Thank you to those that helped to make this happen.
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9 Mar 2018
Attended by 30 students to review last year and elect the new committee. Congrats to the outgoing team, the new committee has big shoes to fill! Click here for the 2018 Committee.
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Technical Tuesday "Sterilization - A Simple Approach"
20 Mar 2018
The first session was attended by over 20 participants. Thanks to M+W for hosting our discussion.
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Challenges and Advances in Cleaning Ultrafiltration Membranes used in Bioprocessing
4 Apr 2018
Facilitated by:
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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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