"Spring is nature's way of saying let's party." -- Robin Williams
Living as we do, in the tropics, the 4 seasons may come and go without notice, perhaps marked by holidays and festivals. Whether that's Qing Ming, Songkran, Easter or Sakura blossoms, Spring is in the air!
Spring cleaning is the practice of thoroughly cleaning a house in the springtime. The practice of spring cleaning is especially prevalent in climates with a cold winter. In many cultures, annual cleaning occurs at the end of the year, which may be in spring or winter, depending on the calendar.
The term is also used metaphorically for any kind of heavy duty cleaning or organizing enterprise. A person who gets their affairs in order before an audit or inspection could be said to be doing some spring cleaning.
Quite apt for this industry, don't you think?
Best regards,
Your ISPE Singapore Affiliate
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PhD MBA, Head of Global Quality Control, Roche/Genentech
Dear colleagues,
These days we hear a lot about 'Innovation', 'Industry 4.0' and how our ways of doing things will change ...to the ultimate benefit of our patients we have the privilege to serve within the biotech and pharma industry.
My time in Singapore and working regionally in South-East Asia has taught me many things about trying to work differently and approaching challenges with the power of diversity.
I learned that organizations can be fast in the implementation of innovative technologies following the principle of "think big - start small - scale fast". The regional diversity in infrastructure and standardization is fostering this principle, while ensuring specific regulatory requirements are met. A key enabler for such agility is the openness to change as part of an organisation's cultural fabric.
Indeed, many recent studies from consulting firms in the pharmaceutical industry report that the main behavioral drivers for successful projects are empowerment, ownership and openness to change.
Many of us already knew this - having worked through many different projects in our respective organizations. Still, it is interesting to see companies once again focusing on those behaviours in the midst of the current innovation revolution.
The success and especially the pace of ISPE Singapore is remarkable, and I attribute this to the mentioned behavioral drivers of successful organisations and especially the swift adaptation. Very recently you have elected the new EXCO and its team composition strongly suggests continued support for the innovation within the region of South- East Asia.
It is now 6 months since I left Singapore. I remain connected to the ISPE Singapore chapter, and keep what I learned during my time there at the forefront of my mind - especially important to me now as we are experiencing this unprecedented period of accelerated innovation.
Working in a global environment is exciting also because you see so many aspects of innovation in different parts of the world.
I believe the key to success for our industry will be to stay focused and find new ways of identifying and quickly implementing true and real "moon-shot technologies" - while meeting compliance and regulatory requirements - to maximise benefits for our patients.
I am excited and look forward to hosting the Compliance and Regulatory track this year at the ISPE Singapore conference. If you have topics and aspects you want to share and/or present during the conference, please let me know. I'd be very happy to chat with you!
Best Regards,
Georg Singewald
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Executive Committee member of the ISPE Singapore Affiliate
This seminar drew 50 attendees from 20 different pharmaceutical companies in Ho Chi Minh on 10 April. They held the role of Quality Assurance or Quality Control, Engineer, Business Development and Quality Management for new projects.
Hosted by Exyte, the 1 day seminar provided simultaneous translation from English to Vietnamese and comprised topics on:
- Accelerating Growth in Pharmaceutical Markets
- Digital Transformation in GMP production
- Safety - Quality - Transparency: Binding Values for Business Success
- Optimized Delivery Model for Life Science Production Facilities
- EU GMP Requirements for Medical Products.
During this seminar, I gained direct feedback from many existing and new pharmaceutical companies about ISPE Singapore's joint workshop with DAV in Ho Chi Minh last year. Da Nang emerged as a popular location and preferred topics include: EU GMP Requirements for pharmaceutical, how to bridge the compliance gap from GMP WHO to EU GMP.
As the majority of the Vietnamese Life Science industry is not familiar with ISPE, such opportunities are ideal to generate awareness and new members in a dynamic growth market.
Through our good connection with the regulator, once they announce their new Centre for Education Head, we will discuss plans for future events. Watch this space!
Catherine Pham
+84 764742474
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Drive and Leverage Innovation for Pharma -
2019 ISPE Europe Annual Conference
Vice President, ISPE Singapore Affiliate
The pharmaceutical industry is evolving so rapidly, with agility and flexibility, we will all have to advance and adapt ourselves to innovative technologies and approaches. To solve the challenges facing patients, i.e. drug shortage, drug price and to solve the challenges facing manufacturers, including patent cliff, long approval cycle, etc.
My major takeaways from the conference could be best summarized in a few key areas:
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valves require only FOUR MINUTES PER CHANGEOVER, a reduction of up to 75%.
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COMING SOON!
ISPE Singapore Quiz Night 2019
25 Apr 2019 | 6.30-9.30pm
Harry's @ Harbourfront
Don't miss our most popular annual social event of the year! Bring your team and sign up with 4-6 friends, or sign up individually and have a team assigned to you.
FREEFLOW beer/soft-drinks/wine, plus finger food!
Member - S$10 | Non-member - S$40
Pharmaceutical Technology Transfer Training Course
Practical Application of Technology Transfer (T19)
6 & 7 May 2019 | 9.00 - 5.00pm
Holiday Inn Singapore Orchard City Centre
Attend this official ISPE 2 day practical application course to identify criteria for successful technology transfer. It will provide examples and tools for industry and regulators to use when conducting and evaluating technology transfer activities.
Technical Tuesday:
PM Group Office, 1 International Business Park, The Synergy,#02-15/16
Join our regular discussion-based community of practice - NO Powerpoints!
Hygienic Equipment - Mechanical Lifecycle & Care
14 May 2019 | 6.00-7.00pm
Pressure Relief Design - Background
11 Jun 2019
| 6.00 - 7.00pm
23 Jul 2019 | 6.00 - 7.00pm
Brainstorming Session
29 May 2019 | 5.00 - 7.00pm
Raffles Marina
All are welcome to this event to brainstorm for future events and share your aspirations, knowledge, experiences and even concerns for career or for life.
The discussion will be facilitated by a group of inspiring female leaders.
Transport will be provided from various sites in TUAS. Please indicate your interest in the registration form.
Contamination Control Considerations and Cleaning Challenges in Pharmaceutical Manufacturing
10 Jun 2019 | 8.30am - 5.00pm
Genting Hotel Jurong
Microbial contamination and product cross-contamination are two of the major challenges faced by manufacturing companies within GMP regulated industries. Join this seminar to take preventive action: to design an effective cleaning process, understand various causes of contamination and the strategies for remediation and preventive measures.
Facilitated by:
ISPE Singapore Student Chapter
Our student chapter is keeping busy this year with new events in the line up.
Mark your calendars:
BioPharma 2020
29 Jun 2019
SIT@Dover
Pheature (A NUSPS & ISPESC Joint Conference)
21 & 22 Sep 2019
NUS UTwon
Skills Workshop series
July-August (Saturdays)
NUS MD Building
Level Up Season 2
14 Dec 2019
Temasek Polytechnic
Thirsty Thursday with ISPE!
4 Jul 2019 | 6.30 - 8.30pm
Twenty15@BigBox, Jurong
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
21-23 Aug 2019
Suntec Convention & Exhibition Centre
Mark your calendars for our annual event, packed with learning, case study experience and informative exhibition. Call for papers open!
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 2nd Seminar 2019
Effective Auditing of Pharma Cleanroom HVAC and other Critical Utility Systems
9-10 May 2019
Ambassador Hotel, Bangkok, Thailand
ISPE Indonesia Annual Conference
24-25 Jun 2019
Holiday Inn Hotel, Kemayoran, Jakarta, Indonesia
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We want to hear from you!
Would you like to share some interesting news, articles or highlight any tips or advice for other members?
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Pharmaceutical Technology Transfer Training Course
Practical Application of Technology Transfer (T19)
6&7 May 2019 | Holiday Inn Singapore Orchard City Centre
Technology transfer (TT) includes knowledge transfer and the application of science and risk-based principles including ICH Q8, Q9, Q10, Q11, to support the business requirements from both Sending and Receiving units for drug substance, drug product and analytical procedures.
Technology transfer occurs in many circumstances involving for example active pharmaceutical ingredients (APIs), finished dosage forms and analytical methods. TTs may occur between development and manufacturing sites or to contract manufacturing organizations (CMOs).
This course identifies criteria for successful technology transfe
r and provides examples and tools for industry and regulators to use when conducting and evaluating technology transfer activities. (view program here)
- Introduction to Technology Transfer
- Knowledge: What is it?
- Planning & Success Criteria
- Quality Risk Management
- Phases of the Transfer Process, including Validation
- Analytical Procedures Transfer
- Drug Substance Transfer
- Drug Product Transfer
Take Back to Your Job
Understand technology transfer planning and success criteria including
- Forming the transfer team and developing the charter
- Consolidating knowledge for transfer and developing a technology transfer proposal
- Identifying risks, conducting a risk assessments and developing technology transfer plan
- Executing the transfer
- Developing the process (procedure) qualification
- Finalizing the transfer and performing the review
This course is intended to be useful to anyone involved in technology transfer whether in relation to commercial transfer between manufacturing sites or transfer to manufacturing from development or within development but will be particularly relevant to professionals with technology transfer responsibilities, including regulatory compliance associates, process development scientists, facilities engineers, validation and quality assurance specialists, manufacturing managers, and regulators.
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Technical Tuesday
This new series, launched in 2018, has gained a steady with a dozen events held over the year.
Importance of a Preventive Maintenance on Sterilizer Equipment
9 Apr 2019
SCT - Spray cover test, Dry Ribo vs Wet Ribo
26 Mar 2019
ICH Q9 101: A discussion on the quality risk management and its various application
26 Feb 2019
Cleaning Validation - How clean is clean?
12 Feb 2019
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ISPE Singapore Inaugural Charity Ball
29 Mar 2019
With a live auction and donation draw, over S$ 10,000 was raised for VIVA Foundation for Children with Cancer. Thanks to all who participated, donated and sponsored, including Exyte, Pharmedley, 1Supplier, Repassa, AVON Group, KPC, PM Group, No Deviation & STERIS.
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24 Jan 2019
Held at Park Hotel Alexandra, over 60 members attended the AGM, followed by Networking Drinks at the Aqua Luna. Thanks to our 2019 AGM sponsors: 1Supplier, No deviation, PM Group, Repassa & STERIS
See who's on your 2019 Executive Committee here
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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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