It's already mid-year and we're looking forward to meeting you, our members and non-members at our annual Conference & Exhibition in August.
We're also pleased to see increased attendance at our events and your committee is working hard to provide you with more social and educational opportunities in the months ahead.
Your feedback and suggestions for improvement are most welcome, or better still, contact us and get involved in our programmes!
Best Wishes,
from your ISPE Singapore Affiliate
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Guest Editorial
Bob Tribe
Asia Pacific Regulatory Affairs Advisor,
ISPE & former Chairman, PIC/s Australia
PIC/S in the Asia Pacific Region
Since retiring from TGA, Australia in 2004, after 23 years as Head of GMP at TGA, most of my consultancy work has involved assisting regulatory authorities around the world to obtain PIC/S membership.
Many of these authorities are from the Asia Pacific region; of its 24 countries, 19 are being influenced in some way by PIC/S. For example, ASEAN countries that are not yet members of PIC/S have committed to use the PIC/S GMP Guide as the basis for their GMP inspections.
The table below summarises this growing influence of PIC/S in Asia Pacific (regulatory authorities of).
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Current PIC/S Members
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PIC/S Applicants being assessed
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Interested in joining PIC/S
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Using the PIC/S GMP Guide
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Australia
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Philippines
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P.R. China
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Cambodia
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New Zealand
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Thailand
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India
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Laos
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Singapore
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Bhutan
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Myanmar
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Malaysia
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Brunei
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Indonesia
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Vietnam
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Taiwan
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Japan
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South Korea
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Hong Kong
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The fact that PIC/S decided to hold its most recent annual event in Indonesia in October, 2015 highlights the importance of Asia Pacific to PIC/S. This Seminar provided training to GMP inspectors on "How to Inspect Manufacturers of Biopharmaceuticals"
The current Vice Chairman of PIC/S is Mr Boon of HSA, Singapore; he will become Chairman of PIC/S in 2018 for a 2 year period. This will likely coincide with China being assessed for PIC/S membership - an important milestone for PIC/S once China becomes a member.
As Chairman of PIC/S in 2000 & 2001, I know about the hard work that lies ahead for Mr Boon. He is currently Chairman of a PIC/S project to establish the PIC/S Inspectorates' Academy (PIA) which is an on-line training platform for PIC/S GMP inspectors. ISPE has offered Mr Boon assistance with training materials for this important training Academy, with upcoming discussions on this and PIA, to be held at the ISPE Singapore Conference & Exhibition on 25 - 27 August 2016
.
Mr Boon will be attending this conference as a speaker and in a Panel Discussion on
"Meeting Inspection Requirements of Major Regulatory Bodies"
, along with regulators from Japan (Mr Morisue of PMDA), Singapore and ASEAN Inspectorates (Mr Sia of HSA), Thailand (Ms Manchanda of Thai FDA), WHO, Switzerland (Mr Sachedva of WHO PQ) and Europe (Dr Revithi, former Head of GMP of a European regulatory authority). I will be moderating this Panel Discussion and I look forward to an interesting panel discussion with these regulators.
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ISPE Singapore Conference Committee Member & Senior Technical Regulatory Specialist, Global Regulatory Affairs, GSK Vaccines
ISPE SG: What prompted you to join ISPE Singapore?
CL:
Being able to contribute back into the science/pharma business in Singapore on the same topics that fuel my passion at work.
ISPE SG: How does your experience here compare with your previous postings?
CL:
My current job allows me to discover and learn from the complexity of the operational side of a pharmaceutical business, while decisions on my previous posting protected the Singapore publics' health. On both fronts, the core values remain i.e. to contribute and shape the medical industry for the future and to protect patient's health.
ISPE SG: What prompted your participation in this year's Conference Planning Committee and what highlights are you looking forward to at the 2016 Conference?
CL:
I am impressed with the drive of the core team and their ability to bring to the audience the most relevant and cutting edge topics. I'm also happy to be able to contribute to their planning this year.
ISPE SG: Anything else that you'd like to share with our readers?
CL:
Organization of the event took months of preparation and planning. The amount of pre-conference work performed behind the scene are substantial; and is a key element in delivering the best topics and speakers for you. This event is also an excellent platform to share best practices and to lay a stronger foundation for the future of Singapore's pharmaceutical industry. You will find that the topics will deliver both breadth and depth - valuable to both beginners and established professionals in the business. I hope you will find this years' conference informative and enjoyable.
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Featured Article
Implementation of the Dance Floor Concept: A Case Study
Presented by Dave Wolton, Biopharma Technology Consultant at PM Group
With over 25 years of experience, Dave Wolton is one of PM Group's experts in Biopharmaceuticals manufacturing and a member of our in-house international technology team. Dave has particular expertise in single use equipment and lean design, with a significant contribution to the next generation of cell culture facilities. He is continually looking for ways to achieve operational excellence whilst remaining focused on compliance with industry regulations and standards.
In the past few years, Dave has spent much time developing the well-known "Ballroom Concept" and publishing many industry articles on his theory of the "Dance floor Concept". This approach seeks to learn from operational facilities and suggest ways of improving their performance. His work champions the reduction of movement, fitting the facility around the equipment, standardisation and defined tubing paths; making the facilities leaner, smaller and more reliable.
At this year's ISPE conference in Singapore, Dave will present his work on the "Dance Floor Concept" and a case study demonstrating the implementation on a recent project. He will detail the development of the concept and the challenges faced with implementing these new practices into a full GMP environment, while adhering to a project's fast tracked schedule.
Dave Wolton is scheduled to speak at 09:45 - 10:30 on Friday, 26th August, 2016. For more information go to: www.ispesingapore.org
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Introductory Workshop to Biosafety (
sold out)
20 July 2016 | 2.00-5.30pm
Devan Nair Institute for Employment and Employability
Conducted by Basler & Hofmann Singapore
YGen Challenge 2016
30 July 2016
Organized by the ISPE Singapore Student Chapter. Contact Kristina for more information:
[email protected]
ISPE APAC Meeting 2016
23-24 Aug 2016
Suntec Singapore
ISPE Singapore Conference & Exhibition
24-27 Aug 2016
Suntec Singapore
Our annual gathering.
Early Bird closes 22 July 2016!
View 2015 event photos
here
ISPE Singapore Student Poster Competition 2016
25 Aug 2016 | 2.00-6.30pm
Suntec Singapore
1st prize: all expense paid trip to the ISPE Annual Meeting in Atlanta, GA USA
YP Go-Karting Challenge
2 Sept 2016 | 6.30-9.30pm
Kartright Speedway
Rev up and test your driving skills! Open to all and organized by the Young Professionals.
ISPE Singapore Soccer Tournament 2016
Oct/Nov
Enter your team for this annual competition! Contact
Kristina for more information.
Effective Pharmaceutical Audits & Self-Inspections
PQMS Auditor/Lead Auditor Course A17638
28 Nov - 2 Dec 2016
Marina Mandarin
EARLY BIRD RATES END 15 JULY!
Save S$ 600 each by registering TODAY!
This IRCA Certified Auditor training is led by UK-based NSF Health Sciences and was fully subscribed last year.
Don't miss this opportunity to attend world-class education from ex industry GMP and MHRA auditors.
View 2015 event photos
here
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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Recruitment:
Young Professional Executive
ISPE Singapore is looking for a young professional to join the team, on a full time basis.
Responsible for supporting the association in communications, social media and organization, the ideal candidate will possess a scientific and/or engineering education and preferably some work experience.
For a job description and to apply, please contact
Kristina
Interested in PAT?
Join our exclusive
PAT CoP Email-List and find out about all upcoming PAT related activities.
Vote in ISPE International Board of Directors' Election!
Closing date extended to 31 July. For more information Email Susan Obarski at
[email protected]
We want to hear from you!
Would you like to share some interesting news, articles or highlight any tips or advice for other members?
A S$50 voucher will be given for each one featured in the next issue. Please write in to [email protected]
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** Special Rates End on 22 July! Book your places
here
**
This year's theme is
'Continuous Process Improvement'
. Highlights include:
- Regulatory track representatives from the US FDA, Thai FDA, PMDA and WHO
- Singapore speakers from HSA and EDB
- Operational, risk-based approaches and technological topics
- HVAC & Cleanroom technology, GMP Guidance & Best Practice
- Good Automated Manufacturing Practices (GAMP)
- Tracks on automation and future technologies, aseptic processes, and critical utilities
- Post event half day workshops: Plant of the Future, Operational Optimisation & Chromotography Community of Practice
- Facility site tours to Novartis & Baxalta
"The event has been very well planned and structured. Great opportunity to meet similar people in the Biopharmaceutical industry" -
PM Group
"Comprehensive overview of single use technologies and trends in facility design. Learnt a lot about ASEAN as well!" -
GSK Biologicals
"The topics have been very insightful this year. Will definitely be attending next year." -
CAI
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Young Professional Awareness Talk: A Head Start in the Pharmaceutical & Biotech Industry
Organised by the Student Chapter, over 150 students attended this evening.
A special thank you goes to the Guest Speakers: James Graham (PM Group), Jerry O'Sullivan (Lend Lease), Geoff Brown (No deviation), Brian Orman (Novartis) and Gillian Hoe (GlaxoSmithKline Vaccines)
Thanks to sponsors CAI, No Deviation & STERIS for their support.
ISPE Training: Practical Implementation of Process Validation Lifecycle Approach (T46)
ISPE Certified trainers, Bruce Davis and Maurice Parlane from UK and Australia respectively, conducted Singapore affiliate's first Process Validation training in May. The intensive 3 day course and accompanying pre-event Introduction to Statistics for Validation workshop, met with rave reviews. An enthusiastic group of 21 attendees gained invaluable insights and practical knowledge to apply on-the-job.
We look forward to running more ISPE training to equip and develop our members' and professionals' skill-sets.
Sponsored by CAI, No Deviation & STERIS.
Introduction to Statistics for Validation Workshop
10 May 2016
A prelude to the ISPE PV Training, this standalone session was attended by the majority of participants and helped boost their understanding of statistics for validation.
Sponsored by CAI, No Deviation & STERIS.
ISPE Singapore Quiz Night 2016
Our most popular social event of the year was packed to capacity as we moved to Harry's @ Esplanade. Over 80 participants in 17 teams tested their general and industry knowledge. Congratulations to the winning team from CAI 'Sassy Agents" who emerged victorious!
Thanks to our annual sponsors, CAI, No Deviation & STERIS, along with Repassa and SciMed for their support.
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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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