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Welcome to the Spring edition of the newsletter.
Certainly, we are living in a situation that is unprecedented for most of us! We are going through an extraordinary period, and we are collectively responding to it with extraordinary measures.
With the omnipresence of the COVID-19 pandemic, we are all adjusting to new ways of working. Protecting the health of our employees, volunteers and members is the first priority. To this end, we have limited our event schedule during this period of social distancing. Many of our products, solutions and services ISPE members provide are improving healthcare systems, so it is important we keep our engine running to serve communities that rely on us. The ISPE website, online training, good practice guides, and communities of practice remain active for our members to engage with.
At the same time, we have implemented business continuity plans for our annual conference to ensure that we continue to serve our sponsors and partners. As a member or not, you may consider attending the conference with peace of mind as we have a full money back policy in the event of continued disruption.
As a non-profit professional society, we have faced many challenges during our history in Singapore. And each time, we successfully overcame them with teamwork and a common sense of purpose. I am confident we have the right capabilities, values and unity to see us through this current crisis. I also deeply appreciate the determination, commitment and effort that everyone is demonstrating to go the extra mile in this challenging period.
Please stay healthy, take care of your loved ones, and stay focused on the important things. We will come out stronger.
Best regards
Geoffrey Brown, Editor
ISPE Singapore Affiliate
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Editor's Pick
iSpeak is the official blog of ISPE. There is no better way to stay connected to other members, the pharmaceutical industry, or look out for volunteer opportunities!
Learn how we can support pharmaceutical supply chains during this critical period:
Your membership now has more value! Take a look at some of the online exclusives to the Pharmaceutical Engineering® magazine:
ISPE Women in Pharma is looking for collaborators-here is your chance to get your voice heard:
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Interview with... 
Alfonsus Karli
APAC GCMC Advisory Office Director, Pfizer Pte Ltd
& ISPE Singapore affiliate Vice Chair, Regulatory Affairs
ISPE SG: What do you enjoy most in your current role?
AK: I have been in the various regional regulatory positions for more than ten years. The current role that I hold is considered new, which I have undertaken since Oct 2019. What I enjoy the most from this new role is learning how science and technology can influence the regulatory policy, for example ICH Q12, Q13. I also enjoy interacting with various colleagues and regulatory agencies, understanding their perspectives and helping them comprehend the novel science and technology.
ISPE SG: At this time, what do you believe are some key lessons we can learn and apply in our industry?
AK: Exchanging knowledge is the key lesson in regulatory affairs. Every different industry has a different strategy of regulatory filing. Currently, we don't have a forum, where industry can share their success or even their failure that we can learn to avoid in the future with agencies in the region. I hope that Technical Tuesday or Regulatory Focus Group / Communities of Practice would be among the tools that can be used for knowledge sharing.
Apart from knowledge, I also believe that we need to have a training or education center that can assist professionals and agencies to understand new science and technology that are impacting the registration, e.g. gene therapy regulation, etc. Due to the current situation, it would also be wise to consider an online/virtual training course that we can access online anywhere.
ISPE SG: We look forward to our annual conference, including the Regulatory and Compliance track. What would you like to hear about which would be most useful in the near/long term?
AK: ICH Q12 - Lifecycle Management and ICH Q13 - Continuous Manufacturing are the topics that I would like to hear in our annual conference. I believe these two topics would not be only beneficial to the industry but also to the regulatory agencies since these two topics can be considered new in the region. I also believe that the industry will start utilizing these two concepts in their regulatory filing in the next few years. A few days ago, I had a call with a global team and we were exploring to apply ICH Q12 in the region.
ISPE SG: Is there anything that you'd like to share with our readers?
AK: Regulatory environment is very dynamic. Regulatory requirements that I used to know 10 years ago are evolving and different from regulatory requirements now. In some countries, the regulatory submissions become less complex, but the majority of regulatory requirements are getting more complex as the agencies are progressively more experienced. However, this creates intricacies in industry as the latter needs to meet the regulatory requirements for each country in the world. I hope that one day, we will have more uniform requirements to reduce the number of divergences from one country to the other country, even though they are in the same region.
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VIVA Foundation For Children with Cancer
Make sure hope is not cancelled!
Cancer does not stop-even in the midst of the #COVID19 pandemic.
VIVA is putting together a
Stay Home Pack
to show our support for children and families affected by childhood cancer as they stay home during this difficult period. And we need your help!
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Cleaning and disinfection - a one or a two steps process or scienctifically justified?
by Walid El Azab, Senior Manager, Technical Services, STERIS Life Science
Debunking the myth of cleaning and disinfection - is it a one or a two steps process, and what is the scientific justification?
The objective of this article is to clarify when a one or a two-step cleaning and disinfection procedure (for clean rooms and non-contact product surfaces) should be implemented. In other words, is a separate and distinct cleaning step always needed prior to disinfection?
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Help us to organise more relevant sessions for you!
Technical Tuesday:
Online until CoVid-19 restrictions are eased
Join our regular discussion-based community of practice - NO Powerpoints! Open to all and FREE to attend!
Contact us
if you'd like to facilitate a session with a proposed session title and preferred dates.
28 Apr 2020 | 6.30 - 8pm
Cell & Gene Therapy - Engineering Perspective
Led by Hugh McKee, Senior Process Consultant, PM Group & ISPE Singapore affiliate Technical Chair
26 May 2020 | 6.30 - 8pm
Automation: Most Common Design Issues
Led by Michael Krispin, Principal Automation Engineer, Integrix Solutions
30 Jun 2020 | 6.30 - 8pm
QbD (Quality by Design) & PAT (Process Analytical Technology) : Challenges and Opportunities
Led by Dr Chew Wee, A*Star & ISPE Singapore affiliate Subject Matter Expert, PAT
28 Jul 2020 | 6.30 - 8pm
Regulatory Divergence
Led by Dyfrig Wilson, Head of Regulatory Affairs, Emerging Markets, Upjohn at Pfizer &
Alfonsus Karli, APAC GCMC Advisory Office Director, Pfizer Pte Ltd
& ISPE Singapore affiliate Vice Chair, Regulatory Affairs
29 Sep 2020 | 6.30 - 8pm
Continuous Manufacturing Experience
Led by Thomas P Garcia, Research Fellow in Global CMC, Pfizer & Co-leader, ISPE Continuous Manufacturing Group
ISPE Singapore Quiz Night 2020
23 Apr 2020 | 6.30 - 9.30pm
* Postponed: Dates to be announced soon
Don't miss our most popular annual social event of the year.
Food and drinks provided; bring your trivia knowledge along with you!
Registration Fee - S$10 for members / S$40 for non-members.
Women In Pharma - Mentoring Evening
27 May 2020 | 5-7pm *Subject to change in CoVid-19 restrictions
Raffles Marina
This roundtable discussion will be led by senior industry peers and is open to all. Light refreshments will be provided.
Registration Fee - Free for members / S$10 for non-members or at the door.
Biosafety Workshop
Jun / Jul 2020 | 2-5.30pm *Subject to change in Covid-19 restrictions
Genting Hotel Jurong
This introductory workshop will be led by Archlab (Basler & Hofmann). It will cover Biosafety standards and hazards and introduction to a BSL-2 and BSL-3 laboratories. Light refreshments will be provided.
Registration Fee - S$10 for members / S$40 for non-members or at the door.
Register your interest here
Thirsty Thursday with ISPE!
2 Jul 2020 | 6.30 - 8.30pm
*Subject to change in Covid-19 restrictions
Meet old and make new friends conveniently in Jurong East. Finger food & first round on the house!
ISPE Singapore Conference & Exhibition
26-28 Aug 2020
Suntec Convention & Exhibition Centre
Expect more speakers, more content, more learning and networking as we celebrate our 20th annual Singapore affiliate meeting. We welcome back our regional and global regulators who will be back on the speaker panel.
Contact us if you'd like to include your event here. (Postings are vetted according to ISPE guidelines on commercial content and subject to approval by the committee.)
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Thailand Affiliate Annual Meeting
15-16 July 2020
Details will be posted as they become available.
Indonesia Affiliate Annual Meeting
*NEW DATES!* 15-16 September 2020
Holiday Inn Kemayoran Hotel, Jakarta
Deadline for Exhibitor Participation & Call for Papers: May 31st, 2020
India Affiliate Annual Meeting
*NEW DATES!* 6-7 November 2020
Sterile Manufacturing Conference, Mumbai
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NEW! WFH Series: Upgrade your Skills Online!
Make the most of this time to improve your productivity with the following sessions.
Volunteers needed to pitch in on MS-Notes, MS-Teams, GoogleHangout, WebEx & GoToMeeting
- MS-Excel & Airtable, led by Pierre Winnepenninckx
21 Apr 2020 | 6.30-7.30pm
- Online Meeting Tools, led by Hugh McKee (Zoom),
tbc: MS-Notes, Teams, GoogleHangout, WebEx, GoToMeeting
23 Apr 2020 | 6.30 - 7.30pm
- MS-Word & PPT, led by Geoff Brown
30 Apr 2020 | 6.30 - 7.30pm
- How to look good on camera, according to Tom Ford:
- How to use Microsoft Teams:
- Writing High-Quality Standard Operating Procedures
A Practical Course to Upgrade Your SOP Writing Skills
Approx 5 hours | Online | Course fee: US$ 90 (Usual price US$ 180) 30 day risk free money back guarantee
This hands-on, online course offers a step-by-step roadmap to take your SOP writing skills to the next level-and write high-quality SOPs. The learning objectives are as follows:
1 Quality:
Define high-quality SOPs.
2 Structure:
Create the right content structure for SOPs.
3 Process:
Follow the right process for writing SOPs.
4 Writing:
Apply the best writing practices.
Course instructor:
Atul Mathur, Content Alive
Atul is a certified trainer and HVAC engineer with over 25 years of experience, mostly in the areas of design, commissioning and qualification for the pharmaceutical industry.
Equivalent to 1½ days of workshop, the course includes high-quality lectures and learning materials downloads (slides in PDF and also workbooks with exercises). It can be completed in hourly sessions over 1-2 weeks (click here for suggested lecture plan).
ISPE Singapore Exclusive!
Online Q&A,
1
2 May | 6:30-7.30pm
Ideally for those who have registered and completed the course (but open to those who are interested).
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Fear, Focus and Fruitfulness - Tips to keep Focused in Challenging Times
TONIGHT! 15 Apr 2020 | 8pm (12pm GMT)
Led by UK affiliate's 'awesome coach-in-residence' Dr Catherine Evans Joines
For more information on the webinar or instructions on how to join, please email
bip@ispeuk.org
Next webinar date/times to be advised later:
- Mental Wellbeing and Overwhelm First Aid - Practical Strategies for You (and your Family)
- Working Effectively in Remote Teams - The 3 pillars of Structure, Trust and Communication
If you would like to help the Life Science Sector support the current pandemic and are looking for resources please consider the following links
ISPE UK Affiliate
https://ispe.org/uk-affiliate/Covid
ISPE COVID19 Resources
here
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| Exclusive offer to ISPE Singapore Affiliate |
Exclusive offer to ISPE Singapore Affiliate members & readers
SAVE 50% off the fee! Enter ISPESG in the Discount Code on the checkout page
Data Integrity Overview-Good Documentation Practices for Electronic Data
Taught by Monica Cahilly (US$ 399.00 per person per link)
27 Apr 11pm-12.30am / 28 Apr 8-9.30am Singapore time
Management Culture & Data Integrity Governance Plans
Taught by Monica Cahilly (US$ 399.00 per person per link)
28 Apr 11pm-12.30am / 29 Apr 8-9.30am Singapore time
Reviewing Electronic Data & Metadata, such as Audit Trails
Taught by Monica Cahilly (US$ 399.00 per person per link)
29 Apr 11pm-12.30am / 30 Apr 8-9.30am Singapore time
Data Process Mapping - Case Studies
Taught by Monica Cahilly (US$ 399.00 per person per link)
30 Apr 11pm-12.30am / 1 May 8-9.30am Singapore time
Data Integrity and Risk Management in Manufacturing Operations
Taught by Peter Baker (US$ 199.00 per person per link)
5 May 8-9am Singapore time
Computer Software Assurance & Data Integrity: A Risk-Based Approach
Taught by Peter Baker (US$ 199.00 per person per link)
6 May 8-9am Singapore time
Data Integrity & Chromatography; A Data Governance Approach
Taught by Peter Baker (US$ 199.00 per person per link)
7 May 8-9am Singapore time
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Talk & Tea: 'A Survivor's Journey'
7 Mar 2020
Marking International Women's Day, we were inspired to hear from Dr Julia Gandhi, Chair, Student Affairs/Faculty Advisor and judge for our Student Poster & Hackathons.
Thanks to Jacobs Singapore for hosting the venue and roses for all participants ;)
View photos here
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CQV101 Technical Tuesday with Pierre Winnepennickx |
Technical Tuesday: CQV 101
31 Mar 2020
Our first TT for the year was led by Pierre Winnepenninckx, CEO, No Deviation & ISPE Singapore Affiliate Conference Chair. The online Zoom / Klaxoon session was interactive with 20 attendees from Singapore and overseas, including Macau and India!
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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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