Agenda

Day 1: 30 August 2018

Opening Plenary

  • Opening Remarks from ISPE Singapore
  • Keynote Address
  • Site Director’s Panel Discussion: Driving a Quality Culture Through Leadership
    Panellists:
    Chai Meng Chong, Head of Mammalian Manufacturing, Lonza Biologics
    Marc O’ Donoghue, Site Director API and Biologics Operations, AbbVie, Singapore
    Vincent Loret, Site Director, GlaxoSmithKline, Singapore
    Dr Jincai Li, Vice President, Biologics CMC Development, Tech Transfer, Scale-up & Clinical Manufacturing, WuXi Biologics
  • Government Address: The Mover Towards Pharma 4.0

Track A
Logistics and Distribution

Track B
GAMP/Data Integrity and Industry 4.0

Track C
Sterile and Aseptic Operations

Day 2: 31 August 2018

Track D
Regulatory and Compliance

Track E
Process Validation

Track F
(AM) Product Transfer
(PM) Single Use Systems 

23 August 2017, Wednesday

Tour 1:

PUB’s NEWater Visitor Centre Tour and Technical Briefing
(0930 – 1130)
**Transportation will be provided to/from Suntec and lunch will be provided for those attending both site tours.

International Society for Pharmaceutical Engineering ISPE Conference & Exhibition

The NEWater Visitor’s Centre is an education hub that promotes water sustainability in Singapore. It promises a fun-filled and enriching time for visitors with an interactive tour and technical briefing.


Tour 2:

Novartis Manufacturing Facility Site Tour (FULLY BOOKED!)
(1330 – 1530)

**Transportation will be provided to/from Suntec and lunch will be provided for those attending both site tours.

International Society for Pharmaceutical Engineering ISPE Conference & Exhibition

Novartis Technical Operations (NTO) Solids Singapore is a state-of-the-art bulk solid dosage manufacturing facility located at the Tuas Biomedical Park. The facility was officially opened in October 2007 and was designed to meet the excellent quality, safety and environmental standards for which Novartis is known. NTO Solids Singapore is a highly qualified site, approved by the FDA (USA), PMDA (Japan), KFDA (Korea), EMA (Europe), ANVISA (Brazil) and HSA (Singapore). The process of manufacturing solids at the site includes sieving, dispensing, granulation, blending, tableting and coating.


Tour 3:
Cultural Heritage Tour
(1830 – 2130)

Join fellow attendees and committee members on a guided walk through the colourful Geylang district.
Learn about the history of this area while sampling local snacks, followed by a seafood feast at ‘No Signboard’ Restaurant with the ISPE Singapore Exco members.

Please note that only one-way transport is provided and price excludes alcoholic beverages. Cost of alcoholic beverages will be borne by the individual. 

24 August 2017, Thursday

09:00
Opening Remarks from ISPE Singapore

Geoffrey Brown, President, ISPE Singapore Affiliate

09:15
[Government Address] Progressing the Biologics & Pharmaceutical Development Vision for Singapore

  • Global trends and drivers in the biopharmaceutical sector
  • The Singapore biopharmaceutical manufacturing landscape
  • Ongoing efforts to continue to enhance Singapore’s competitiveness and success

Nigel Cheong, Head of Biomedical Sciences, Singapore Economic Development Board

09:30
[Panel Discussion] Global Trends in Pharma and The Role of Manufacturing in Meeting the Challenges

  • The drug shortage conundrum
  •  Patient centred and data / technology driven approach
  • The rise of precision medicine
  • How manufacturing can play a role
  • Capital projects and manufacturing facilities

Moderator: 
Pierre Winnepenninckx, Past Chair of ISPE Asia Pacific and Chair, ISPE Singapore Conference 2017

Panellists: 
Maurice Parlane, 2016 ISPE Member of the Year, Director of ISPE Australasian Affiliate and Director of Centre for Biopharmaceutical Excellence, Australia
Christian Cater, Associate Director, Business Excellence, Roche, Singapore
Hazem Eleskandarani, Global Director, Commissioning & Qualification, Johnson and Johnson Engineering and Property Services, USA
Vee Revithi, Head of External Relations, Europe, Roche, Switzerland
Chris Sweeney, Senior General Manager, PT Kalbio Global Medika, Indonesia

10:15
Supplying Hope: Compassionate Use from the Patient’s Perspective

Nicole Pierson, Patient Advocate, Mother of Gavin Pierson; Keynote Speaker at ISPE Atlanta 2016 Conference, United States

Track  A: Technical Excellence

Moderator: Howard Yu, Quality System and Compliance Lead, Novartis BioProduction Operations, Singapore

Track B: Realities of GMP

Moderator: Maurice Parlane, 2016 ISPE Member of the Year, Director of ISPE Australasian Affiliate and Director of Centre for Biopharmaceutical Excellence, Australia

Track C: Design, Commissioning and Qualification

Moderator: Damian Thornton, Vice President Asia, C.A.I, Singapore

11:30

Liquid Nitrogen as Coolant For Biological Storage Units

Dr. Georg H. Thiessen, CEO, Cryo Life Science Technologies GmbH, Austria

11:30

[Interview Session] How Does Data Governance and Integrity Regulations Change The Quality Culture of Your Organization?

11:30

Design Fundamentals of an Autologous Cell Therapeutics Facility

David Kapitula, Operations Partner, C-Bridge Capital, China & Vice President Quality, CMAB,China
Damian Thornton, Vice President Asia, C.A.I,Singapore

12:00

ISO 16890: New Global Standard For General Ventilation That Brings Healthy Well-Being At Work

Lionel Savin, Global Clean Process Product Manager, Camfil, Singapore
Jayant Kaushal, 
Director Product and Project Management Office, Camfil, Singapore

12:00

Risk Management:  Preventing Cross Contamination in the Context of HPAPIs

Dean M Calhoun, CIH, President, Affygility Solutions LLC, USA

12:00

Risk-based Approach to C&Q

Hazem Eleskandarani, P.E., Global Director, Commissioning & Qualification, Johnson and Johnson Engineering and Property Services, USA

12:30

Processes and Factory of the Future: Single Use and Flexibility for Faster, Cheaper and Safer Manufacturing

Jerome Pionchon, Engineering Consultant – BioReliance E2E Solutions, Merck Life Sciences, France

12:30

[Case Study] The Laughs and Tears of Building a GMP Compliant Facility in Southeast Asia

Chris Sweeney, Senior General Manager, PT Kalbio Global Medika, Indonesia

12:30

Customized Engineering Design and Manufacturing of Large-scale mAb Bioreactor Production Line

Ghislain Dousset, Director of Operations, Pierre Guerin SAS, China

13:00
Lunch in the Exhibit Hall

13:00
Lunch in the Exhibit Hall

13:00
Lunch in the Exhibit Hall

A: Monoclonal Antibodies

Moderator: Pierre Winnepenninckx, Past Chair of ISPE Asia Pacific and Chair, ISPE Singapore Conference 2017

B: Realities of GMP 

Moderator: Maurice Parlane, 2016 ISPE Member of the Year, Director of ISPE Australasian Affiliate and Director of Centre for Biopharmaceutical Excellence, Australia

C: Design, Commissioning and Qualification

Moderator: Damian Thornton, Vice President Asia, C.A.I, Singapore

14:15

Strategies for Continuous Bioprocessing

Hang Zhou, Director of Cell Culture Process Development, WuXi Biologics, China

14:15

HPAPI Drug Manufacturing And Case Study on Nanogram Level Containment Technology

Pierre Landais, Business Manager, APAC, Powder Systems Ltd (PSL APAC), Australia

14:15

Factory of the Future

John Duggan, Asia Director of Life Sciences, PM Group, China

15:00

[Case Study] Successful Technology Transfer from One Site to Another

Mountain Yueh-Chun Hsieh, Head of Transfer & Manufacturing Science and Technology (MSAT), Boehringer Ingelheim BioPharmaceuticals (China) Co., Ltd

15:00

Cloud Based Quality Management Systems

Joseph Micsko, Operations Manager, PSC Biotech, Singapore

15:00

The Quality Role in A Major Engineering Project

Matthew Luo, Vice President, Quality Assurance, Livzon Mabpharm Inc., China

15:45
Afternoon Refreshments

15:45
Afternoon Refreshments

15:45
Afternoon Refreshments

16:30

New Approaches to Establishing Biopharma Manufacturing

Firman Ghouze, Bioprocess Strategy Director, GE Healthcare Life Sciences, Singapore

16:30

A Case Study of a Multisite Monitoring System in GxP Environment

Paul Daniel, Senior Regulatory and Compliance Expert, Vaisala, USA

16:30

Integrated Solutions Initiative and A&E (Architectural and Engineering) Collaboration

Jeff Wong, Global Associate Sales Director Bio Production Core Accounts and Integrated Solutions, Thermo Fisher Scientific, USA

17:00

Ensuring Quality and Safety in Biologics Production Using Glyco-Analytical Platforms

Terry Nguyen Khuong, Associate Staff Scientist, Bioprocessin

17:00

[Best Practice] Flexible Containment Solutions for Pre-Clinical Through Scale-Up Process

Scott Patterson, Vice President Commercial Sales, ILC Dover, USA

17:00

Design Approach for Pre/ Post Viral Segregation

Stefan Kappeler, Senior Project Manager, Compliance & Validation, M+W Group, Switzerland

17:30
PharmaNite Networking in Exhibit Hall
ISPE Regional Student Poster Competition Awards & Passport Draw

19:00
PharmaNite Dinner (Registration required)

Executive: Leaders and managers with broad scope of responsibility
Advanced: Experts with advanced skills that want to stay current
Intermediate: Developing an expertise in a specific area

25 August 2017, Friday

Track D: Lab Analytical Technology

Moderator:
Carissa Choh, Consultant, HGP Asia, Singapore

Track E: Regulatory Compliance

Moderator:
Bob Tribe, Asia Pacific Regulatory Affairs Advisor, ISPE, former Chairman, PIC/S, Australia

Track F: Cleaning Validation

Moderator:
John Hyde, Chairman and Founder, Hyde Engineering + Consulting, USA

09:00

Quality Control of Upstream and Downstream Processes
Marcel Langoor, Director Business Development, Eurofins Sinensis, Netherlands

09:00
Regulatory Updates:
Europe, MHRA Update:
Gerald W Heddell, Director, Inspection Enforcement & Standards Division, Medicines and Healthcare Products Regulatory Agency (MHRA), UK

Thailand Update: Life after PIC/S
Membership: Real Challenges for Authority and Industry
Suchart Chongprasert, Director of Post Marketing Control Division, Bureau of Drug Control, Thai FDA

PIC/S Update:
Dr Vee Revithi, Head of External Relations, Roche, Switzerland

International Regulatory Convergence
Bob Tribe, Asia Pacific Regulatory Affairs Advisor, ISPE, former Chairman, PIC/S,
Australia

[Panel Discussion] Regulators Panel Discussion

Moderator:
Bob Tribe, Asia Pacific Regulatory Affairs Advisor, ISPE, former Chairman, PIC/S,
Australia

Panellists:
All regulatory speakers of the day
Sia Chong Hock, Senior Consultant (Audit & Licensing) & Director (Quality Assurance), Health Products Regulation Group, HSA Singapore

09:00

Cleaning Design from An End User Perspective
Robin Toh, Associate Director, Validation, Lonza Biologics, Singapore

09:45

Analytics for Biopharmaceuticals Operations
Jaspreet Singh, Vice President Quality, Intas Pharmaceutical Ltd, India

09:45
(Continue)

09:45

Risk Assessment in Fungal Spore and Bacterial Spore Excursions
Richard Chai, Technical Service Manager, STERIS Corporation | Life Sciences, Singapore

10:30

UltraLow Temperature Freezers – The Economics of Cold Storage
Tim Kehrli, Director of New Business Development – Asia, Stirling Ultracold, USA

10:30
(Continue)

10:30

Cleaning Validation for a New Biologics Manufacturing Plant
Vincent Vagenende, Validation Expert, MS&T, Novartis BioProduction Operations, Singapore

11:15
Morning Refreshments

11:15
Morning Refreshments

11:15
Morning Refreshments

11:45

Application of Spectroscopy and Other Physical Characterization Techniques in Pharmaceutical Manufacturing
Effendi Widjaja, Senior Manager, Technical Operations – Asia Pacific, Johnson & Johnson Pte Ltd, Singapore

11:45
Drug Shortages & Patient Access
Gerald W Heddell
, Director, Inspection Enforcement & Standards Division, Medicines and Healthcare Products Regulatory Agency (MHRA), UK

11:45

Cleaning of Product Contact Parts
Jerome Chua, Division Manager, ITS Science and Medical (Representative for IWT Italy), Singapore

12:15

Control of Genotoxic Impurities by UV and Mass Detection in Pharmaceutical Manufacturing
Wellyana Chua, LC and Informatics Business Development Specialist, Southeast Asia, Waters Pacific Pte Ltd, Singapore

12:15
[Panel Discussion]: How Well Are Regulators and Industry Doing in
Protecting the Patient?”

Moderator:
Pierre Winnepenninckx
, Past Chair of ISPE Asia Pacific and Chair, ISPE Singapore Conference 2017

Panellists:
Nicole Pierson
, Patient Advocate, Mother of Gavin Pierson; Author of Be Strong and Brave, United States
Gerald W Heddell
, Director, Inspection Enforcement & Standards Division, MHRA, UK
Vee Revithi
, Head of External Relations, Roche, Switzerland

12:15

Evaluating Cleaning Data: A 21st Century Perspective
Mohammad Ovais, Ex-Scientific Affairs Manager, Xepa Soul Pattinson, Malaysia

13:00
Lunch in the Exhibit Hall

13:00
Lunch in the Exhibit Hall

13:00
Lunch in the Exhibit Hall

Track D: Process Analytical Technology

Moderator:
Chew Wee, Scientist, Institute of Chemical and Engineering Sciences, A* Star, Singapore

Track E: Regulatory Compliance

Moderator:
Bob Tribe, Asia Pacific Regulatory Affairs Advisor, ISPE, former Chairman, PIC/S, Australia

Track F: Cleaning Validation

Moderator:
John Hyde, Chairman and Founder, Hyde Engineering + Consulting, USA

14:00

[Case Study] Implementation of CU-NIR Technology
Yang Ying, Analytical Science and Technology Facilitator, Novartis Singapore Pharmaceutical Manufacturing Pte Ltd
Wong Poh Mun, Manufacturing Science and Technology Validation Expert, Novartis Singapore Pharmaceutical Manufacturing Pte Ltd

14:00

Challenges in Moving to PICs New Chapter 1 – Pharmaceutical Quality
System (PQS)
Steve Williams, Director and Senior Partner, Centre for Biopharmaceutical Excellence, Australia

14:00

Drying Equipment and Piping Post CIP and SIP Operations
Jonathan Toke, Vice President, Haskell, USA

14:30

In Situ Raman Spectroscopy for Bioprocess Monitoring and Control Improves Protein Product Quality and Titer
Igor Nazarov, Strategic Account Manager, Kaiser Optical Systems Inc., USA

14:30
(Continue)

14:30
(Continue)

14:45
(Continue)

14:45

Pharmaceutical Life Cycle Management
Aziza Ahmed, Director, Regulatory Affairs CMC APAC, MSD International GMbH, Singapore

14:45

Strategies For Cleaning Validation That Minimize Downtime For Product Change Overs
Pradeep Chakravarty, Vice President, Corporate Quality, Lupin Ltd, India

15:00

SIPAT – The Software Heart of Process Analytical Technology and Real-Time Release
Ivo Backx, Business & Project Development Manager for Pharmaceutical Industry, Siemens AG, Germany

15:00
(Continue)

15:00
(Continue)

15:30
Afternoon Refreshments & Passport Draw

15:30
Afternoon Refreshments & Passport Draw

15:30
Afternoon Refreshments & Passport Draw

16:00

Use of Process Analytics in Continuous Primary Manufacturing
Clarence Wong, Technical Development Manager, Glaxo Wellcome Manufacturing Pte Ltd, Singapore
Martin Hermanto, Senior Chemometrician, Glaxo Wellcome Manufacturing Pte Ltd, Singapore

16:00

How Pharma Manufacturers are Adapting to the Changing Regulatory Environment
Vee Revithi, Head of External Relations, Roche, Switzerland

16:00
[Panel Discussion] Ongoing Monitoring of Cleaning Performance: Maintaining a State of Validation for Cleaning Operations

Moderator:
John Hyde, Chairman and Founder, Hyde Engineering + Consulting, USA

Panellists:
Robin Toh, Associate Director, Validation, Lonza Biologics, Singapore
Pradeep Chakravarty, Vice President, Corporate Quality, Lupin Ltd, India
Mohammad Ovais, Ex-Scientific Affairs Manager, Xepa Soul Pattinson, Malaysia

16:45
[Panel Discussion] Implementing PAT: 
Opportunities and Challenges

Moderator:
Chew Wee, Scientist, Institute of Chemical and Engineering Sciences, A* Star, Singapore

Panellists:
All PAT Speakers for the Day

16:45

How to Audit RA Department to Ensure Compliance
Jack Wong, Head of Regulatory Affairs, APCA, Baxter Healthcare and Founder and Secretariat, Asia Regulatory Professional Association (ARPA), Singapore

16:45
Q&A Session

17:30
Close of Conference

Executive: Leaders and managers with broad scope of responsibility
Advanced: Experts with advanced skills that want to stay current
Intermediate: Developing an expertise in a specific area

26 August 2017, Saturday, 0900 – 1230

G: Risk Assessment And Management

Facilitator: Maurice Parlane, 2016 ISPE Member of the Year, Director of ISPE Australasian Affiliate and Director of Centre for Biopharmaceutical Excellence, Australia

H: Impact of EU Annex 1 on Resources and Costs

Facilitator: Walid El Azab, Technical Service Manager, STERIS Corporation Life Science, Belgium

I: State-of-the-Art Biopharma Facility Design

Facilitator: John Hyde, Chairman and Founder, Hyde Engineering + Consulting, USA
Bo Xu, Chief Operating Officer, Zhejiang Teruisi Pharmaceuticals, China

Key Learning Outcomes

  • A deeper understanding of QRM and applicable GMP requirements for this
  • Ability to recognise situations where design/ process risk management and operational risk management are required
  • Understanding of various risk assessment tools and their applicability to GMP
    situations
  • How to avoid bias or ineffective use of common risk assessment techniques
  • Reference materials and examples of application of selected risk management tools

Key Learning Outcomes

  • Learn about the future EU GMP Annex 1 requirements.
  • Understand the link between different regulatory requirements and the impacts on
    the field
  • Be capable to assess the impact of the current practices versus the future
    requirements
  • Share best practices between attendees
  • Discuss the revisions proposed by different entities and organizations
  • Compare your compliance readiness versus other aseptic manufacturers

Key Learning Outcomes

  • Understand the utilization of single-use versus stainless steel components for the manufacture of MAb bulk drug substances
  • Review and evaluate each approach from the perspective of Capex, Opex and time to
    market optimization
  • Understand the up-front commissioning, qualification and validation requirements of
    each approach
  • Comprehend the bases for optimal selection of either technology for any unique
    manufacturing circumstance