ISPE Communities

We understand that the sheer scale of ISPE can be overwhelming. To circumvent this, we are delighted to offer ISPE Communities, which are free to be part of. Smaller groups of people will convene for discussion-oriented roundtables to initiate focused networking in a more intimate setting.

Participants will have access to the full ISPE attendee list, can source meetings and visit the virtual booths.

Attendance at the roundtables is free, but this does not give access to the main conference. Please register separately if you wish to attend the main conference.

Attendance at the roundtables is free, but this does not give access to the main conference.
Please register separately if you wish to attend the main conference.

DATA INTEGRITY LIVE THEATRE

Sponsored by

8 December 2020 | 3pm – 4.30pm SGT
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Data integrity is of utmost importance in any CGMP pharmaceutical manufacturing setting now more than ever. Data integrity guidance may not be a new concept but there is increased scrutiny of data integrity and compliance matters are on the rise. This session will benefit manufacturers who are trying to attain a high degree of data integrity, benchmarking regional manufacturers, and this is an open forum to encourage discussions for effective implementation and outlining robust strategies.

This session is sponsored and chaired by NNIT.

Chairperson’s Opening Remarks
Sudjati Rahardjo, 
Principal Consultant, NNIT Singapore

15:00-15:20
Data Integrity Compliance and Key to Reduce Data Integrity Violation Trends

Hosted by:
Shantha Kumara, Quality Assurance Manager, Strides Pharma, Singapore

15:20-15:40
Statistical Techniques for Product Quality Improvement & Monitoring

You will learn:

  • Importance of applying statistical thinking to quality improvement
  • Overview of practical and simply statistical methods used for quality improvement
  • Practical and statistical considerations when choosing a statistical method to use

Hosted by:
Md. Zakar, Executive Director, Plant Operations, NIPRO JMI Pharma Ltd., Bangladesh

15:40-16:00
Developing a Robust Quality System to Assure Data Integrity

You will learn:

  • Regulatory trends and guidance in Philippines’ pharma industry
  • How data integrity and process monitoring are critical to each other for regulatory compliance
  • Link between data integrity and quality culture
  • Remaining pain-points in data integrity

Hosted by:
Cloyd Lambojon, Supervisor Production / Site Data Integrity Lead, GSK, Philippines

16:00-16:30
Q&A with the Hosts – Chaired by NNIT

Moderator:
Sudjati Rahardjo, Principal Consultant, NNIT Singapore

Speakers:
ShanthaKumara, Quality Assurance Manager,Strides Pharma, Singapore
Md. Zakar, Executive Director, Plant Operations, NIPRO JMI Pharma Ltd., Bangladesh
Cloyd Lambojon, 
Supervisor Production / Site Data Integrity Lead, GSK, Philippines

MANUFACTURING FOR THERAPIES OF THE FUTURE-CHALLENGES AND OPPORTUNITIES OF PERSONALISED MEDICINE

Hosted by

8 December 2020 | 4pm – 5pm SGT
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(Separate Registration Needed)

*Limited seats, Registration subject to approval

Discussion topics include

  • Personalized medicine require rethinking logistics and manufacturing facilities
  • Miniaturization of the manufacturing systems with full automation, fully integrated manufacturing platforms, what are the benefits and compromises?
  • Manufacturing hubs and small scale onsite therapy manufacturing, what direction will prevail?
  • Cut Cost of Goods and Time to Market in a competitive market, how can Pharma 4.0 help?

Moderator:

Luca Mussati, Vice President Pharma and Biotech, Exyte

Panellists:

Dr. Stefan Kappeler, Technology Manager GBU Biopharma & Life Sciences, Exyte
Gordon Nicholson, Technical Director for APAC Life Sciences Business Unit, Exyte
Hermann Bohnenkamp, VP Business Development APAC, Miltenyi
Ulf Bethke, Head of Clinical Products, Senior Vice President, Miltenyi
Mr Andrew Whytock, Head of Digitalization and Innovation, Pharmaceutical Business Segment, Siemens

PANEL & ROUNDTABLE DISCUSSION ON ‘THE POWER OF YOUR PERSONAL BRAND’

8 December 2020 | 5.30pm – 7pm SGT
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Join our distinguished panel of inspiring women leaders from the region! Explore what makes up a personal brand, how to develop it, and how to promote it to improve your opportunities and success:

  • How do you distinguish yourself in our highly competitive world?
  • Engage your personal brand to gain your next promotion, new job, or new opportunity.
  • Use your personal brand to secure your seat at the table and get you paid what you are worth.
  • Develop your personal brand to set you apart from others who have a similar education, experience, and credentials.

Moderator:
Shanshan Liu, President, ISPE Singapore Affiliate

Panel members & roundtable hosts:
Dr. Julia Gandhi, Chair/Adviser, Student Affairs Faculty, ISPE Singapore
Vivien Santillan
, President, ISPE Philippines & co-Chair, ISPE APAC
Herny Prasetya, President, ISPE Indonesia
Dr Sasivimol Kittivoravitkul, Treasurer, ISPE Thailand
Vasiliki (Vee) Revithi, Ex-Head, GMDP Inspectorate, EOF Medicines Agency of Greece 

This session is FREE and open to all (regardless of gender)

PANEL DISCUSSION: REACHING DIGITAL MATURITY THROUGH PHARMA 4.0

10 December 2020
5:45PM – 6:30PM Singapore Standard Time (SST)
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A more in-depth and extensive discussion on the main conference theme “Innovations in Digital Pharma”, meant for the interest of every stakeholder group involved in the pharmaceutical & healthcare industry.

Discussion points cover:-

  • Applying Big Data, information systems and digital tech in pharma manufacturing
  • Life cycle management for organisation and process
  • Major issues and success factors facing digital transformation
  • Communication and decision making driving cultural change 

Moderator:
Pierre Winnepenninckx, Conference Chair, ISPE Singapore Affiliate & Chief Executive Officer, No Deviation Pte. Ltd.

Panellists:
Roger Harty, Director of EMEA & APAC, AstraZeneca, Belgium
James Wu, Chief IT Officer, Roche, Taiwan
Samme Wang, Head of Engineering and Technology Asia, Bayer, Singapore
Rajnish Narula, Director Business Excellence, Pfizer, Singapore

PANEL DISCUSSION: LEAN MANUFACTURING OPERATIONS – ACHIEVING MORE WITH LESS

11 December 2020
4:30PM – 5:15PM Singapore Standard Time (SST)
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The intention of this discussion is to engage the audience in an in-depth discussion on strategies to achieving pharma operational excellence and best practices when it comes to lean manufacturing operations.

Discussion points cover:-

  • Strategies to achieving pharma operational excellence
  • Best practices to optimise flexible and agile production
  • Reducing waste, maximising productivity

Moderator:
Shanshan Liu, President, ISPE Singapore Affiliate

Panellists:
Minh Tran, Chief Operating Officer, Stelis Biopharma, India
Meidi Fransisca Siregar, IT Manufacturing Lead, PT Bayer Indonesia
Ahmad Fikri Hasim, Head of Production, Ain Medicare Sdn Bhd, Malaysia

Ask The Expert! Discussion Forums

Attendance at the discussion forums is free, but this does not give access to the main conference. Please register separately if you wish to attend the main conference.

Discussion forums are topic-centered chat rooms hosted on the Swapcard conference platform. These chatrooms are OPEN TO ALL but requires sign-up. Click the “Register Now” button to register for your free visitor pass.

Sustainability Water Clinic

Chatroom Hosted & Sponsored by:

Synopsis: Water treatment and compliance if done properly need not be costly and nerve wrecking. In this Water Sustainability Clinic, Veolia water experts will offer some tips and advice on how to tackle challenges in every phase of your water cycle from compendial validated water to effluent treatment. Below are some topics covered, however, you are welcome to seek consultation on any challenges you may have.

Discussion Takeaways:

  • Optimizing energy consumption in your water cycle
  • Ensuring consistent microbial compliance
  • Performing beyond local discharge standards on EDCs and PPCPs

Best safety from endotoxins in pharmaceutical water & Reducing HVAC energy consumption

Chatroom hosted by REPASSA with technical experts from BWT & Telstar

Sponsored by:

Synopsis (HVAC) : The challenge of reducing HVAC energy consumption and operation costs without negatively affecting the quality of the finished products, ensuring cleanrooms always conform to required specifications

The SmartCR is an innovative flexible solution for cleanrooms that adjusts air changes which reduces energy consumption and operation costs, ensuring cleanrooms always conform to required specifications. The adjustment is done through the HVAC control system, considering inline particle counters, differential pressure transmitters and temperature and relative humidity probes.

Synopsis (Endotoxin) : Endotoxins are the most potent exogenous pyrogens. Even very small amount can cause excessive activation with consequences like high fever, drop in blood pressure, clot formation in the capillaries and multi-organ failure. Due this clinical significance, the contamination of pharmaceutical preparations and medical devices must be avoided at all costs. The pharmacopoeias as Ph. Eur., USP, JP and CP state clear limit values for Endotoxin Units. In this topic we enlighten how to limit the risk in pharmaceutical water systems (critical utilities) to the absolute minimum, either by use of thermal distillation systems or environmental friendly and cost-effective membrane-based solutions and the right storage and distribution solution to maintain that quality level. All this is backed up and concluded with figures from studies and systems from practical experience.

Discussion Takeaways:

  • Why are endotoxins a risk
  • What do the applicable regulations say.
  • Then we look at the technology: Which processes are best suited to remove endotoxins beyond the required level in a permanent and safe way.
  • Finally, we look at the practice: What are the experiences – which solutions have proven to be reliable and what do we have to pay more attention to?
  • At the end of the day participants have a checklist with 5 points for safety from endotoxins.