Welcome to our first regular ISPE Singapore Newsletter!
We'd like to thank all our members and supporters for your commitment over the years and as we grow, we aim to continuously improve our communications as well as our offerings, in the form of activities, events and socials.
Best Wishes,
from your ISPE Singapore Affiliate
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Guest Editorial
Pierre Winnepenninckx
ISPE Singapore Affiliate President 2014/2015
Dear Members,
I'm writing this message at the end of my 2 years as Singapore affiliate President.
During these 2 years, we saw the rise of a new conference, an increased number of events including more social events such as the networking night and soccer tournament. Also we have thought of bringing healthier food to our events, in line with our driver to improve not only patients' lives but our own! So next time, feel free to stop at the salad bar.
Our successes are only possible thanks to both members and non members, showing interest in networking and sharing knowledge. Not to forget the committee, industry professionals and sponsors supporting us.
On a Global level, ISPE is undergoing a deep reshape and some might have noticed it through the new template of the PE magazine.
But I can assure you this is only the beginning. If ever, now is time to join us. You can expect the following in the coming months: a new logo, a new website, more training online, a record year in terms of publication and guidance documents. But maybe what impacts you more is an enthusiastic committee for 2016, an improved conference program, the come-back of the baseline guide training in Singapore (all you wish to know on statistics and Process validation brought to your door step), and of course this, our first regular Newsletter, published quarterly on the 15th Jan, April, July & October.
Our Exco members are dedicated to bringing more value for members, and are developing new ideas such as a PAT Community of practice. It may be challenging, but we are blessed by the level of knowledge here and the location of Singapore, to drive new initiatives that could be soon leading the path in Asia and worldwide.
As you might know, the presidency of ISPE Singapore Chapter is capped at 2 years and I am more than happy to step down and handover my obligation to the next president during our AGM election on 21st January. Being recently assigned with the function of ISPE Chair for Asia, I will never be far away and hope to see you all at our next events.
Wishing you a successful 2016!
Pierre Winnepenninckx
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Geoff Brown
ISPE Singapore Conference 2016 Chairman
ISPE SG:
What brought you to Singapore?
GB: I first came to Singapore in 2004 as part of a deployment aboard the submarine I was attached to. I was lucky enough to meet my wife on that trip. Early in 2013 I was lucky to find a project for work out here and have been here since.
ISPE SG: What did you enjoy most about the ISPE Singapore Conference this year?
GB: A couple of things come to mind. Most obvious, the ISPE Singapore anniversary dinner hosted by CAI and Agilent was a blast. Even organizing the event, I wasn't quite sure what we signed up for, but it turned out to be a lot of fun.
I was able to moderate the session with Atul Mathur as well on Writing Clear, Concise and Effective Standard Operating Procedures. I was able to take to work the next day, a valuable skillset, which I was immediately able to implement.
ISPE SG:
What's your vision and what can we expect from the 2016 Conference?
GB: We're building the presentation tracks this year from the ground up. We've collected many results from an information survey (thanks to the many that participated!) so I'm excited to build the conference around the challenges our members see day-to-day at work.
Also, we're adding more strategic sessions for management as well as the technical, practical workshops. Next year, we hope to introduce ISPE US Baseline Training to Asia.
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Featured Article
DESIGNING A CLEANRO
OM DI
SINFECTANT PROGRAM TO MEET PRODUCTION REQUIREMENTS
AND REGULATORY EXPECTATIONS
By Elaine Sartain Kopis
The primary objective of a cleanroom disinfectant program is to control contamination in the production environment so that safe, pure, and effective drugs can be manufactured. There are challenges inherent in this task due to a number of factors in the drug manufact
uring environment including:
- Facility design issues such as HVAC, traffic flow, and substrate selections;
- Personnel issues such as training, compliance, and supervision;
- Issues concerning the development and implementation of the disinfectant program
In the article above, the author discusses how a
well-developed and executed disinfectant program can be both a short-term solution and a long-term strategy for environmental control. The requirements of an effective and validated disinfectant will consist of:
- Identification of the type of evironment isolates that are found in the cleanroom
- Determine the type of products effective against the environment isolates
- Facility Design and Condition, including substrate compatibility
- Rotation of appropriate products to address wide biospectrum of micro-organism
- Adopt the appropriate disinfectant efficacy protocol and conduct the testing
- Execute Disinfectant Validation
- Develop residue control program with an effective rinsing strategy
A cleanroom's disinfectant program should be viewed as part of its entire microbial control program, the outcome of which cannot be greater than the sum of its parts. The success of any microbial control program depends upon many factors, including the facility's design and condition, the thoroughness of personnel training and compliance, and the development of a validated disinfectant program. If a facility experiences an aseptic production failure, each of these elements should be evaluated to identify problems and re-establish microbial control. However, if a manufacturer has thoroughly addressed all of these elements during the initial planning of the disinfectant program, their successes will far outpace their failures.
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ISPE Singapore AGM & Dinner
21 Jan 2016
Jurong Country Club
Volunteer and nominate your Executive Committee
here
Cleaning Validation: A Life Cycle Approach
28 Jan 2016
Genting Hotel Jurong
Facilitated by STERIS
BioPharma Asia Convention 2016
20-24 Mar 2016
Suntec
All members and readers are eligible for a 20% saving off conference registration fees by using the D
iscount Code "ISPE".
Quiz Nite 2016
April (TBC)
PV Training (3 days)
Mid-May (TBC)
Co-organized with ISPE ASEAN & Australia
ISPE Singapore Conference & Exhibition
Our annual gathering.
Call for Papers out soon!
View 2015 event photos
here
Soccer Tournament 2016
Nov (TBC)
NSF Training
Nov (TBC)
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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2016 Committee & Volunteers Wanted!
Are you passionate about what you do?
Do you want to contribute your time and knowledge to the industry?
Would you be willing to help the association as a volunteer or committee member?
ISPE Singapore will be holding its AGM on 21 Jan 2016.
For online nomination click
here
or
email us
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
Join ISPE!
If you
'
ve been thinking about joining ISPE, now is the time to do it! Join ISPE by 30 March 2016 and you will get a Double Bonus worth
€
570.
Your bonus includes a free copy of
Project Management for the Pharmaceutical Industry
(pdf version), a
€
370 value, and a
€
200 conference discount certificate.
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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Effective Pharmaceutical Audits & Self-Inspections
PQMS Auditor/Lead Auditor Course A17638
Organized in conjunction with NSF Health Sciences Ltd, UK
Excellent feedback from the attendees, who all passed the exam. Congrats! Those who joined the preview session found it informative, leaving with new insights and take-away learnings.
Limited to 20 places, dates for N
ovember coming soon.
ISPE Soccer Tournament 2015
3 teams from 13 organisations battled it out on the pitch in a series of exciting matches. Well done all for turning up despite the haze postponement and congratulations to the Winners, the No Deviation squad!
Thanks to sponsors
1Supplier, No Deviation & STERIS
ISPE Chromatography Workshop
20 participants attended the afternoon session and demonstration, held at Merck Millipore's training facility. Feedback was positive with requests for more related workshops.
Watch this space for updates or contact us if you have any specific requests.
Thanks to Merck Millipore for a highly informative and practical event.
Thank you to the sponsor
s 1Supplier, CAI, Fedegari, No Deviation, PM Group and SciMed for supporting this annual social event. Congratulations to team "PMGroup", the winner of the night.
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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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