This is a 'bumper' edition featuring additional articles and news which may be of interest, alongside our Guest Editor, Interview with.. and expanded events section.
Please take a few moments to check out our line-up of educational and social events, created just for you! Where possible and for your convenience, we've included details in the links as well as registration forms online. Time to check your calendar and plan your attendance for the year!
We'd also like to welcome our new Executive Committee and Student Chapter, whose details and photos can be found under the 'Recent Events' links below.
See you soon,
your ISPE Singapore Affiliate
|
Wendy Han
President, ISPE Singapore Affiliate Student Chapter
Warm greetings, everyone!
As a penultimate undergraduate from Nanyang Technological University, I'm humbled to be re-elected as Student Chapter President. I look forward to another successful collaboration with our new executive committee that was carefully assembled and restructured based on individual strengths and aspirations.
Why ISPE Singapore Affiliate Student Chapter?
I am deeply motivated by the cause that ISPE student chapter continually advocates, which is to encourage networking amongst tertiary students from all science and engineering backgrounds. Beyond the mastery of knowledge, today's working professional needs to be equipped with soft skills such as communication, team work, and leadership skills in order to navigate through the ongoing revolution in the global workplace, fuelled by disruptive technology.
Therefore, I'd like to thank ISPE Singapore Affiliate for providing me with ample opportunities to network, build connections and hone my communication and leadership skills.
So, What's Cooking This Year?
This year's YGEN will be completely derailed from the usual orientation-like activities. YGEN 2017 will morph into a large scale event where representatives from the biopharmaceutical industries are invited to share about their previous internship experience, the transition from school to the workplace, and their career development. Additionally, the games and panel discussions will optimise interaction and networking amongst students and industry professionals.
We invite your organisation to sponsor or participate as speakers, to raise awareness and encourage students to become future leaders of the biopharmaceutical industries.
Also in the pipeline are industry visits and the student poster competition where students are invited to submit their research posters and stand to win attractive prizes.
On behalf of the student committee, I would like to thank ISPE and our sponsors for their unwavering support and extend a warm welcome to all of our new student members. Our executive committee is committed to value-add student members through personal empowerment, leadership and networking opportunities. Please feel free to provide any feedback on how we could serve you better at
sgispesc@gmail.com
. Do like our
Facebook page
and/or follow us on
Instagram
to stay updated with exciting content and events that will be coming your way!
|
Interview with...
Danny Tan
Global GMP Compliance Audit Manager, Global Quality Compliance and External Collaboration (PTQG)
Roche Singapore Technical Operations
ISPE SG: How long have you been a member of ISPE and what were your primary reasons for joining?
DT:
I have been an ISPE member since 2011. My primary reason for joining is to meet more like-minded people for sharing of knowledge and to contribute back to the industry that I am passionate about.
ISPE SG: What do you consider your team's biggest challenge in 2017?
DT:
In my personal opinion, in today's context, Data Integrity is the biggest challenge, with the fact that it is now the centre of focus of many health authorities around the world. It's high on the agenda for most companies and regulators, including in Asia. This will continue to impact company policies and our work in the future.
ISPE SG: What new developments will impact what you do in the near future?
DT:
With the attention on Data Integrity in the Regulatory world, I can foresee that there will be more controls on data management, which will require review of current auditing tools and checklists. This will help to ensure that all aspects of data integrity are covered effectively.
ISPE SG: How does ISPE and/or our Annual meeting help you in your role?
DT:
It keeps me updated on this fast changing regulatory landscape of the pharmaceutical industry, which is essential to my role as a GMP Compliance auditor.
In particular, the annual conference allows me to keep up with latest industry trends and practices. It's a good meeting place to gain knowledge, sharing practical hands on experience.
|
Did you read...
This article provides a handy overview of the merging and acquisition of big pharma players in the industry last year and the causes behind it:
Patient safety is a key cause that's being stressed in drug manufacturing. See how product advertisements can be misinterpreted by consumers/patients and put them at risk :
South Korea a promising country for clinical trial destination?
Is cloud storage still a taboo topic for healthcare and pharmaceutical providers?
Patients, Healthcare Professionals: what say you on fast-growing Biosimilar products?
|
|
|
|
|
 |
|
ISPE Singapore Quiz Night
26 Apr 2017 | 6.30-9.30pm
ISPE Singapore's most popular social has moved West to Jurong East! Join as a team or sign up and we'll form one for you. Will CAI's "Sassy Agents" retain their Winner's title?
Click here for registration and details
Process Validation (PV) Workshop: Life Cycle Management & Risk Based Approaches
Gain regulatory updates and practical implementation for your validation programme at this 1 day workshop. Recommended for participants who are familiar with basic concepts of validation and quality risk management prior to attending this course.
YGen Challenge
17-18 Jun 2017, 9am-5pm
The revamped YGEN 2017 has expanded to 2 days, featuring sharing sessions from industry and young professionals, fun and intellectual games. Contact the
Student Chapter for details.
Introductory Workshop to Biosafety
6 Jul 2017, 2-5.30pm
Devan Nair Institute for Employment & Employability
If you missed last year's session, led by Basler & Hofmann, this is your chance to attend!
Thirsty Thursday with ISPE!
6 July 2017, 5.30-7.30pm
Twenty15 @ Big Box
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
23-26 Aug 2017
Watch out for the final programme, out soon!
www.ispesingapore.org
ISPE Singapore Go-Karting Challenge
8 Sep 2017
Kartright Speedway
Save the date!
IChemE Singapore Awards
ISPE Singapore is pleased to be supporting this event in judging the awards.
Pharmaceutical GMP Course
30 Oct - 1 Nov 2017, 9am-6pm
Led by 2 lead trainers from UK based NSF, this comprehensive course will be the first-run in Asia. See brochure for
details and register
here
ISPE Singapore Soccer Tournament
ISPE Data Integrity Conference
16-17 Nov 2017, 9am-5pm
Save these dates for the first joint event with ISPE USA on the industry's current hot topic!
This 2 day regional conference will feature international and regional speakers and authorities. Watch out for more details soon.
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.)
|
|
ISPE Australasia Statistics for Validation
19 Apr 2017, Johnson & Johnson Sydney
20 Apr 2017, Melbourne City Convention Centre
ISPE Australasia Process Validation
1-3 May 2017,
Pullman, Sydney Olympic Park
ISPE Thailand Cleanroom Testing and Certificatoin
2-3 May 2017, Bangkok
ISPE Indonesia Affiliate Annual Conference
9-10 May 2017, Jakarta, Indonesia
ISPE Japan 2017 Annual Meeting
18-19 May 2017, Toyama, Japan
ISPE Philippines Seminar on Microbiology and Cleaning Validation
20/21 Jun 2017, Crowne Plaza Hotel, Quezon City
ISPE Phillipines Seminar on Quality Management System
11/12 Aug 2017, Crowne Plaza Hotel, Quezon City
ISPE Phillipines Seminar on PIC/S updates and Project Management
14/15 Nov 2017, Crowne Plaza Hotel, Quezon City
|
|
|
|
|
Data Integrity - Reflections
No deviation Pte Ltd
Originally, I thought of writing how good No deviation was in data integrity, but it would have been another boring article based on our theoretical view. So, I asked one of our employees to give me his view of why data integrity matters. Funny enough here is his answer:
The topic chosen for this article has a rather unexpected origin - I was making a taxi expense claim for my trip from Tuas to home. However, I did not have the original receipt. Now, I am very convinced I am a person with integrity who would not dream of amassing wealth ($14.20 is an inheritance in some nations) that does not rightfully belong to me. I make taxi expense claims on a regular basis and every claim is almost the same value. So then, why is this piece of thermal paper so significant for the claims process? And are you wondering what in the world this has to do or how it relates to Data Integrity.
Let's define data integrity. As per Wikipedia (not always the best source of information, but it's often the first one available): Data integrity is the maintenance of and the assurance of the accuracy and consistency of, data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data. If you are reading this newsletter you surely sat through Good Documentation Practices (GDP) training and you are familiar with the ALCOA acronym - Attributable, Legible, Contemporaneous, Original, Accurate employed to ensure Data Integrity. So, what could we learn about a taxi claim and why is it important.
Is it important? Looks like it. 21 of 28 FDA warning letters in 2015 were found to be linked to Data Integrity breaches[i]. My taxi expense claim was not one of them but technically it is indeed a Data Integrity breach. Here I will not discuss the Data Integrity specifications and guidelines that are in place. These are comprehensive enough (and also available for free on internet) and focus on the possible opportunities for data manipulation.
Here I would like to focus on the recent interest in the impact of organizational behaviour - incentive (pressure), rationalization, and disconnect between frontline employees and their managers - with regard to Data Integrity.[ii] The Cressey model represents the following 3 elements:
Pressure usually arises from the fear of failure to meet expectations, and incentivization of unreasonable performance output. Does the management lose touch with field staff and reward time-savers while closing an eye on quality? A friend once told me, "Most companies lack the wisdom to connect the dots between the development of their staff, competitiveness and profitability. As a result, they consider training as a side activity and an expense. Good companies place staff development as a high priority, understanding that if their staff is well trained they deliver superior results". But then again, I was not under pressure to do it right when I didn't take the receipt. It would have been far worse to find another taxi receipt to cover my mistake. And I knew I could explain it to my accountant.
The taxi claim has an easier job at raising concern than say, the lack of raw data to substantiate a test result, because I see the consequence directly (I won't get my money back).
In the pharmaceutical industry, having a constant reminder that our primary purpose is ensuring patient safety will reduce the rationalization used to justify data integrity breaches on the grounds that our actions/data do not matter. An ideal company will encourage staff to question routine workarounds and challenge 'veteran' principles if it presents a problem.
One will conclude with a reminder to always ask for the original receipt, especially when taking taxis from Tuas. They can amass expenses very quickly. If you do forget, you are encouraged to ponder on Data Integrity breaches, causes and solutions, and discuss them with us.
The point I am trying to make is that the next time you record something, think of the taxi ticket because the patient depends on it and the reach of your actions is well beyond Tuas.
[i]Current Expectations and Guidance, including Data Integrity and Compliance with cGMP - Sarah Barkow, ISPE Data Integrity Workshop June 5, 2016 Bethesda
|
|
ISPE Singapore AGM 2017 & Networking Dinner & Drinks
Our biggest AGM to date, with 70+ attendees and an enlarged Executive Committee elected.
Meet your 2017 ISPE Singapore committee!
In our first and biggest outreach to 9,000 students, the most commonly asked question was 'who is ISPE?'. We recruited new members and fielded inquiries for internships and full-time jobs. CVs have been collated and are available for viewing if you have positions vacant. Contact Kristina to access the candidates here.
Designing A Risk Based Cleaning and Disinfection Programme
Following last year's popular workshop, we were pleased to welcome 30 delegates for an intensive full day programme. Thanks to STERIS Corporation for providing expert speakers.
2017 ISPE Singapore Student Chapter AGM
10 Mar 2017
Held at NUS, this year's AGM was a fulfilling session attended by around 20 students from both polytechnic and university. Congrats to our new
Student Chapter EXCO!
Biopharma Asia
22-23 Mar 2017
Thanks to all who dropped by and helped out at our exhibition stand this year; the biomanufacturing track of the conference featured some outstanding international speakers.
CoP PAT Meeting
31 Mar 2017
This first session of 2017 saw 40 industry participants from manufacturing, R&D, vendors and regulators. A talk by MKS Data Analytics Solution on multivariate data analyses in PAT applications was followed by brainstorming on PAT and quality-by-design (QbD) implementation locally. Join the community of technology enthusiasts to realise PAT/QbD at future quarterly sessions and a PAT track at the annual conference in August.
BioBiz 2017
1 Apr 2017
Outreach to students at this biomedical conference, organized for students by students.
An estimated 800 participants attended, including polytechnic and ITE students.
|
|
Jobs/Internships wanted!
At recent career fairs and events, we've received and shortlisted potential enthusiastic entry level candidates who are keen to join the industry. If you have openings for full time employment and/or internships, please contact them directly. To view the CVs, please contact
Kristina
.
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.
We want to hear from you!
Would you like to share some interesting news, articles or highlight any tips or advice for other members?
|
Your feedback and suggestions are most welcome as we strive to provide you with membership and industry news updates.
|
|
Contact Us
ISPE Singapore Affiliate
Ph +65 6826 1105
|
|
|
|
