Agenda

09:00
Opening Remarks from ISPE Singapore

Joseph Micsko, President, ISPE Singapore Affiliate

09:10
Ensuring the Supply Of Quality Medications Beyond Domestic Markets

Ferry Soetikno, Chief Executive Officer, Dexa Group, Indonesia

09:40
Panel Discussion: Driving a Quality Culture Through Leadership

Moderator: Pierre Winnepenninckx, Conference Chair, ISPE Singapore 2018

Panellists:
Chai Chong Meng, Head of Mammalian Manufacturing, Lonza Biologics, Singapore
Marc O’ Donoghue, Site Director API and Biologics Operations, AbbVie, Singapore
Vincent Loret, Site Director, GlaxoSmithKline, Singapore
Dr Jincai Li, Vice President, Drug Substance Manufacturing (MFG1), WuXi Biologics, China

10:25
Government Address: The Singapore Biopharma Industry and Supporting Its Shift Towards Industry 4.0

Nigel Cheong, Head, Biomedical Sciences, Economic Development Board (EDB), Singapore

10:45
Opening of ISPE Singapore Exhibition and Morning Refreshments

Track A (AM): Logistics and Distribution

Chair:
Thomas Terranova, ISPE Singapore & MD, Terra Asia Consulting, Singapore

Track B: Process Validation

Chair:
Pierre Winnepenninckx, Conference Chair, ISPE Singapore 2018 & CEO, No deviation, Singapore

Track C: Sterile and Aseptic Operations

Chair:
Joseph Micsko, ISPE Singapore & Operations Director, PSC Biotech Pte Ltd, Singapore

11:30
Managing Temperature Controlled Transportation

Jeroen Kyto, Global Key Account Manager, Pharma, Ceva Logistics, The Netherlands

11:30
Case Study: From Conceptualization to Reality – Facility Design that Maximises Efficiency

  • Addressing the challenges and opportunities in building a world-class facility
  • Implementing single-use and continuous processing systems effectively and achieving cGMP standards
  • Establishing the quality system to control the entire facility

Dr Jeff Chen, Production Manager, PharmaEssentia, Taiwan

11:30
Risk Assessment for Aseptic Processing

Maurice Parlane, ISPE PV Chapter Lead, Director, ISPE Australasia & Director, Centre for Biopharmaceutical Excellence, Australia

12:00
The Critical Role of Supply Chain in Patient’s Safety 

Rateb Al Jallad, Head of Supply Chain, Julphar Gulf Pharmaceutical Industries

12:00
How to Start Successful Process Validation with a Successful Commissioning & Qualification

  • Process validation objectives
  • Successful process validation elements
  • Link between PV and CQ
  • C&Q roadmap leading to successful PV

Hazem Eleskandarani, Global Director, Commissioning & Qualification, Johnson & Johnson, USA

12:00
Best Practices in Bioburden Control in Sterile Manufacturing Cleanrooms

Dr. Stefan Kappeler, Technology Manager Life Sciences, Exyte, Germany

12:30
Traceability & Serialisation: How to Optimise Quality Assurance in Supply Chain

Moderator:
Thomas Terranova, ISPE Singapore & MD, Terra Asia Consulting, Singapore

Panellists:
Jordi Vall-Lossera, Global Head Supply Chain Quality, Novartis, Switzerland
Paolo Rampichini, Head Supply Chain, Pharma, Asia Pacific, Hoffmann-La Roche, Singapore
Rateb Al Jallad, Head of Supply Chain, Julphar Gulf Pharmaceutical Industries, UAE

12:30
Panel Discussion: Transitioning from Project to Validation

Moderator:
Maurice Parlane, ISPE PV Chapter Lead, Director, ISPE Australasia & Director, Centre for Biopharmaceutical Excellence, Australia

Panellists:
Paul Si, Head Project Management Asia, Novartis, Singapore
Melis Tay, Operations Start Up Manager, AbbVie, Singapore
Michael Lee, Senior Vice President, Mab Venture Bio Company, China

12:30
Case Study: New Aseptic Fill Finish Pilot Facility for the Development of High Cost Products

Arnan Ben-David, former Director, Global Sterile Engineering, Teva Pharmaceutical Industries, Israel

13:00
Lunch in the Exhibit Hall

13:00
Lunch in the Exhibit Hall

13:00
Lunch in the Exhibit Hall

Track A (PM): Pharma 4.0
Dave Bartlett, ISPE Singapore
& Senior Automation Manager, No deviation Pte Ltd, Singapore

Track B: Process Validation
Pierre Winnepenninckx, Conference Chair, ISPE Singapore 2018
& CEO, No deviation, Singapore

Track C: Sterile and Aseptic Operations
Joseph Micsko, ISPE Singapore & Operations Director, PSC Biotech Pte Ltd, Singapore

14:15
From Industry 4.0 to Pharma 4.0-The Holistic Control Strategy

  • Pharma 4.0 – Applying the ICH Q10 Pharmaceutical Quality System to Industry 4.0 to achieve 6 Sigma in Pharma
  • The Holistic ISPE approach to the Control Strategy Lifecycle Management enables Data Integrity by Design
  • Pharma 4.0: The silo breaking ISPE Operating Model to bring Quality, Manufacturing, Engineering and big data IT analytics to a predictive Manufacturing Control Strategy.

Christian Wolbeling, ISPE ‘Pharma 4.0” & Co-Chair ‘GAMP MES’ Special Interest Groups, Senior Director Global Accounts, Werum IT Solutions, Germany

14:15
[Workshop] Ongoing Process Verification – Practical Considerations on Implementing a Program for Legacy Products

The workshop will contain some theory/background, but will assume participants are familiar with Annex 15/FDA requirements for PV Stage 3.  The workshop content will primarily largely focus on examples and discussion on how to implement a useful system for trend monitoring and interpret data from that.

Maurice Parlane, ISPE PV Chapter Lead, Director, ISPE Australasia & Director, Centre for Biopharmaceutical Excellence, Australia

13:45
Multi-Purpose Filing Lines for Small Batch Production

Felix Mausolf, Regional Sales Manager, Groninger, Germany

14:15
Overcoming the Traditional Manufacturing Challenges of Sterile Microsphere Drug Production Through Innovative Technical Solutions

Pierre Landais, Asia-Pacific Manager, Powder Systems Limited (PSL), Australia

14:45
Cutting Through the Pharma 4.0 Paradigm – It’s Not about Big Data, but How to Use Your Data

David Staunton, Director of Site Services, Zenith Technologies, Ireland

14:45
Contained Powder Handling for Sterile and/or Toxic Application

Frédéric Dietrich, Managing Director, Dietrich Engineering Consultants sa, Switzerland

15:15
Lean Strategies: Reshaping the Op Ex Manufacturing Function with Industry 4.0

Daniel Sanchez, Senior Manager Operational Excellence, GlaxoSmithKline, Belgium

15:15
Biopharma Process Validation with QbD Approach

Michael Lee, Senior Vice President, Mab Venture Bio Company, China

15:15
Case Study: Multi Format Flexible Filling Line Isolator for All Containers – Design, Workflow and Validation Approach

Sergio Mauri, President, ASCCA, Director of Marketing and Business Intelligence, Fedegari, Italy

15:45
Afternoon Refreshments

15:45
Afternoon Refreshments

15:45
Afternoon Refreshments

16:30
Panel Discussion: Digitalisation Touch Points in Pharma Manufacturing – Trends, Benefits and New Investments

Moderator: David Bartlett, ISPE Singapore & Senior Automation Manager, No deviation Pte Ltd, Singapore

Panellists:
James Weidner, Process Development Site Head, Executive Director, Amgen, Singapore
Wee Ming Chua, Managing Director, Halfmann Goetsch Partner AG, Singapore
Christian Wölbeling, Senior Director Global Accounts, Werum IT Solutions, Germany
Linda Evans O’Connor, Vice President, Chief of Staff, Lachman Consultants, USA

16:30
Cleaning Cycle Development for Parts Washer

Richard Chai, Technical Service Manager, STERIS Corporation, Singapore

16:30
Generating Microbial Identifications and the Impact on Making Confident Operational Decisions: A Process Analytical Perspective on Reducing Errors

Mehul Patel, Global Director of Training, Microbial Solutions, Charles River Laboratories, USA

17:00
A Practical Approach to Cleaning Validation – Guidelines, Limits, Sampling

Jeff Surmon, Global Industry Manager, Alfa Laval China, China

17:00
Panel Discussion: Sterile Manufacturing – Quality, Emerging Technologies and Best Practices

Moderator:
Sergio Mauri, President, ASCCA, Director of Marketing and Business Intelligence, Fedegari, Italy

Panellists:
Arnan Ben-David, former Director, Global Sterile Engineering, Teva Pharmaceutical Industries, Israel
Andy Rayner, Chief Technology Officer, PM Group, Ireland
Wallace Torres, Executive Director Quality Site, Amgen, Singapore
Felix Mausolf, Regional Sales Manager, Groninger, Germany

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

18:30
Women in Pharma Panel Session

Track Sponsor:

Thursday 30 August, 6.30 – 7.30pm

About ISPE Women in Pharma
ISPE “Women in Pharma” (WIP) will provide women in the pharmaceutical industry a forum for connecting and collaborating on technical and career advancement topics. It is also a unique opportunity for women to speak, deliver technical presentations, and contribute to panel discussions. A community of WIP mentors, resources across all levels, and educational sessions will be an enabler for career success and work-life balance.

Agenda:
6.30 – 6.40pm
Introduction – panel bios & WIP initiative

6.40 – 7.10pm
Panel Questions

7.10 – 7.25pm
Audience Questions

7.25 – 7.30pm
Concluding Remarks and Call to Action

Moderator

Liu Shan Shan
Vice President, ISPE Singapore Affiliate

Panel Members:

Sook Peng Chua
ASEAN Regulatory & Quality Compliance Director, Johnson & Johnson, Singapore

Christine Moore
Global Head and Executive Director, GRACS CMC –Policy, Merck, Sharp and Dohme Corporation, USA

Dr. Vasiliki (Vee) Revithi
Ex-Head of EOF / Greece, GMDP Inspectorate, Greece

Michelle Peake
Senior General Manager, PT Kalbio Global Medika, Indonesia

Track D: Regulatory and Compliance

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

Track E: GAMP/Data Integrity

Chair:
Jim Davidson, Vice President of Science and Technology Practice, Lachman Consultant Service, USA

Track F (AM): Product Transfer

Chair:
Maurice Parlane,
ISPE PV Chapter Lead, Director, ISPE Australasia & Director, Centre for Biopharmaceutical Excellence, Australia

09:00
GMP Harmonisation and GMP Inspection Reliance from a PIC/S Perspective

Boon Meow Hoe, Chairman (2018-2019), PIC/S Singapore

09:00
Overview of Data Integrity in the Full Product Life Cycle

Jim Davidson, Vice President of Science and Technology Practice, Lachman Consultant Service, USA

09:00
Case Study: Best Practices on Technology Transfer

  • What to do and what not to do
  • Case studies from first-hand experience
  • The hurdles

Michelle Peake, Senior General Manager, PT Kalbio Global Medika, Indonesia

09:30
Regulatory Updates:

Chong Hock Sia, Senior Consultant, Audit & Licensing, Director, Quality Assurance, Health Products Regulation Group, Health Sciences Authority, Singapore
Vladimir Orlov, Deputy Head of Scientific, Methodology & Training Department of FSI «SID&GP», State Institute of Drugs and Good Practices, Russia
Achiraya Praisuwan, GMP Inspector, Ministry of Public Health, Bureau of Drug Control, Thai FDA

09:45
Efficient Ways to Achieve Data Integrity in Your Lab

Gunnar Danielson, Head of Global Software Solutions, Mettler Toledo GmbH, Switzerland

09:30
Product Transfer Case Study: Product X – A Multi Market Launch

  • Regulatory Submission and Inspection Roadmap
  • Post-Launch Successful Indicators & Review
  • Lessons Learned & Implementation

Immaculada Gomez, Tech Transfer Lead, MS&T, Novartis, Singapore

10:15
Life Cycle Workshop Part 1
Learn to develop risk scenarios based on the user requirements and then assess the risks to data integrity around each requirement

Charlie Wakeham, Informatics CSV Consultant, Waters Australia Pty Ltd, Australia

10:00
Computational Fluid Dynamic Simulation of Bioreactors to Assess Technology Transfer

Albert Dyrness, Chief Technology Officer, ADVENT Engineering, USA

10:30
Followed by Regulatory Panel:

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

Panellists:
Morning speakers & Dr Vasiliki (Vee) Revithi, Ex-Head of EOF/Greece GMDP Inspectorate, Greece

10:30
Developing and Implementing an Effective Technology and Product Transfer Plan

Foo Suan East, Global Product Lead, Process Sciences and Technical Services, Shire, Singapore

11:15
Morning Tea

11:15
Morning Tea

11:15
Morning Tea

11:45
Interview session: Adhering Quality Systems and Functions to Comply with Current Good Manufacturing Practices (cGMP) and Global Regulatory Standards and Requirements

Interviewer: Dr Vasiliki (Vee) Revithi, Ex-Head of EOF/Greece GMDP Inspectorate, Greece
Interviewee: Chang Teck Chung, Quality Director, FQMR, Shire, Singapore

11:45
Integrating Devices and Systems in QC and Production to Enable Data Driven Decisions

Robert Lutskus, Global Product Delivery Manager – Informatics, Lonza Informatics, USA

11:45
Case Study of Meeting GMP for HPAPI’s Containment System and Process Equipment Integration – from R&D to Production Scale

Samuele Bissola, Technical Sales Manager, F.P.S. Food Pharma Systems srl, Italy

12:20
Quality in Focus Panel Discussion:

Moderator: Dr Vasiliki (Vee) Revithi, Ex-Head of EOF/Greece GMDP Inspectorate

Panellists:
Dr. Georg Singewald, Head Quality, Asia Pacific, Solids & Special Technologies, Novartis, Singapore
Sook Peng Chua, ASEAN Regulatory & Quality Compliance Director, Johnson & Johnson, Singapore
Dr. Christine Moore, Global Head and Executive Director, GRACS CMC –Policy, Merck, Sharp and Dohme Corporation, USA

12:20
Case Study on Multivariate Data Analytics Leading to Real-time Process Monitoring & Control

James Weidner, Process Development Site Head, Executive Director, Amgen, Singapore

12:20
Panel Discussion: Managing Challenges of Scale-up, GMP, Risk Assessments

Moderator:
Liu Shan Shan, Vice President, ISPE Singapore Affiliate

Panellists:
Michelle Peake, Senior General Manager, PT Kalbio Global Medika, Indonesia
Albert Dyrness, Chief Technology Officer, ADVENT Engineering, USA
Gary Khoo, Head of Process Development (CMC/ MSAT), Tessa Therapeutics Pte Ltd, Singapore

13:00
Lunch

13:00
Lunch

13:00
Lunch

Track D: Regulatory and Compliance

Chair:
Dr. Georg Singewald, ISPE Singapore
& Head Quality, APAC & MEA, External Supply Operations, Novartis, Singapore

Track E: GAMP/Data Integrity

Chair:
Dave Bartlett, ISPE Singapore & Senior Automation Manager, No deviation Pte Ltd, Singapore

Track F (PM): Single Use Systems

Chair:
Liu Shan Shan.
Vice President, ISPE Singapore Affiliate

14:15
Handling of the Product Quality Complaints

Ameet Ambarkhane, Lead Engineer, Global Technical Operations, Merck, Sharp and Dohme Corporation, Singapore

14:15
Case Study on Data Integrity

Ee Lynn Kok, Director, Enterprise Regulatory Compliance, Johnson & Johnson, Singapore

14:15
Bridging the Gap Between the Reusable to Single-Use Biomanufacturing

Qiwei Wu, Vice President of Process Development and Manufacturing, Livzon Mabpharma Inc., China

15:00
ICH Q12 for Post Approval Changes

Dr. Christine Moore, Global Head and Executive Director, GRACS CMC –Policy, Merck, Sharp and Dohme Corporation, USA

15:00
Data Integrity in the Digital Environment

  • Present our problem statement around quality operations in the shop floor
  • Introduce our customized automated solution and present the project implementation
  • Strategy moving forward in utilizing data for productivity and efficiency improvements
  • Automation strategy for our Facility

 Manuel Ungerer, Head Process Engineering & Technical Services, Novartis Singapore Pharmaceutical Manufacturing Pte Ltd., Singapore

15:00
Integrating Single Use Technology for Efficient and Economic Buffer Operation Design

Sim Li Jun, Technology Manager, Singapore & Malaysia, Biologics Lead-Southeast Asia, Merck Life Science, Singapore

15:30
Afternoon Refreshments and Passport Draw

15:30
Afternoon Refreshments and Passport Draw

15:30
Afternoon Refreshments and Passport Draw

16:00
Human Work Environment When Controlling Operational Risks: Human Error Risk Analysis and Control Strategies

Harry Benson, Director of Human Performance Services, Commissioning Agents International (CAI), USA

16:00
Risk Assessment Workshop Part 2
Define A Validation Approach Based On The Risk Assessment From And Align The Validation Life Cycle Into The Wider Data Life Cycle 

Charlie Wakeham, Informatics CSV Consultant, Waters Australia Pty Ltd, Australia

16:00
Biomanufacturing Excellence Through SUBs

  • Case study on tech transfer to BLA, future opportunities & challenges

Dr. Jincai Li, Vice President, Drug Substance Manufacturing (MFG1), WuXi Biologics, China

16:45
Quality and Regulatory Compliance Risk Management

Jack Wong, Founder, Asia Regulatory Professional Association, Head of Regulatory Affairs, Asia Pacific, Baxter, Singapore

16:30
Adapting Single Use/Stainless Hybrid System for Flexible Manufacturing

Elad Mark, ISPE Singapore, Director/Principal Engineer, Antero Engineering, Singapore

17:00
MES & Data Integrity

Thomas HalfmannPartner, Halfmann Goetsch Partner AG, Switzerland 

17:00
Panel discussion: Addressing Challenges and Opportunities in Product Transfer, Single Use and Other Emerging Technologies

Moderator: Elad Mark, ISPE Singapore, Director/Principal Engineer, Antero Engineering, Singapore

Panellists:
Denise Tan, Principal Engineer, Process Development, Amgen, Singapore
Qiwei Wu, Vice President of Process Development and Manufacturing, Livzon Mabpharma Inc., China
Johann Bonnet, Vice President Business Development – Pharma & Cosmetics, Veolia, France
Raymond Dallago, Director of Sales, SaniSure, USA

17:30
Close of Conference

17:30
Close of Conference

17:30
Close of Conference

Site Tour: 9am – 12pm.

KUEHNE + NAGEL

K+N Singapore
Kuehne + Nagel Singapore has been established since 1970. With the set-up of our specialised vertical logistic teams and the relocation of the regional headquarters to Singapore in 1990, we have the regional experience and technology to get your products delivered to the markets efficiently, effectively through Singapore and the region. Supported with an extensive global network, we deliver source-to-end logistics solutions that connect you from Singapore and Asia to the rest of the world seamlessly.

We are part of the Kuehne + Nagel Group, one of the global leaders in supply chain management with more than 125 years of freight forwarding experience and approximately 1,200 offices in over 100 countries.

Singapore Logistics Hub
Located near pharma and healthcare hubs, major manufacturers and ports, the Singapore Logistics Hub provides 46,000 sqm of warehousing space. Aside from the standard freight and warehousing service offerings, the facility serves as a regional centre of excellence for high-tech, industrial, pharmaceutical and healthcare customers, offering supply chain optimisation and value-chain transformation solutions.

More than 40 per cent of the logistics hub has been furnished with advanced chilled storage, redressing and postponement facilities:

  • 2ºC – 8ºC and 15ºC – 25ºC
  • Vault room for controlled-drug and or high value cargo storage
  • Sealed loading bays installed with air-curtains and individual power-charger temperature-controlled models such as reefers and or active shippers
  • Stringent security system round the clock
  • Advanced fire protection system & sprinklers system with more than 1,000 smoke detectors

Exclusive Dinner Sponsored by Fedegari Group

Thursday, 30th August 2018
7.30pm | Otto Ristorante

*Attendance is subjected to approval

Shanshan serves as Vice President for the current year for ISPE Singapore Affiliate. In her role, she is greatly involved in conference and event planning, promoting ISPE, providing technical input and supporting the President and the Affiliate with all relevant business. With a few other EXCO members, they initiated Technical Tuesday, a series of recurrent events where experience and knowledge is shared and issues and solutions are discussed within the industry.

Shanshan has been in the industry for more than 12 years. Her major role has been process SME, with adequate experience in CQV, project management as well as business development. Shanshan has lived and worked in Europe and Asia. She previously held the role of  Senior Technical Expert within Novartis global engineering team.

By training, Shanshan is a Biochemical Engineer, with a M.Sc. degree received from the University of Birmingham, UK.

Sook-Peng Chua is the Snr Director, Business Quality for Johnson & Johnson based in Singapore. During her 27 years of career, Sook Peng has held technical and quality leadership roles with global healthcare, both pharmaceutical and medical device companies such as Baxter, GSK/GSK Biologicals. Sook Peng earned a Masters in Sciences from National University of Singapore after completing her research on Signal Transduction in Tumor Cells in Institute of Molecular and Cell Biology. She has extensive auditing, operational experience and has led several commissioning – validation projects in medical device, pharmaceutical greenfield startup manufacturing facilities.

Dr. Christine Moore is Global Head and Executive Director, GRACS CMC – Policy at Merck. Christine joined Merck after 11 years in various positions in the US FDA, including Acting Office Director of the Office of New Drug Quality Assessment and of the Office of Process and Facilities. Prior to moving into the regulatory CMC area, she spent 10 years at Pfizer and Searle/Pharmacia in API process development, process analytical technologies, scale-up, and technology transfer. She holds a BS in Chemical Engineering from Northwestern University and a PhD in Chemical Engineering from MIT.

Throughout her career, Christine has focused on the development of scientific and regulatory approaches for advancing pharmaceutical manufacturing technologies, modernizing regulatory guidance, and progressing international harmonization.  She has been a thought leader in progressive regulatory approaches for pharmaceutical manufacturing in the areas of Quality by Design, process analytical technology, and continuous pharmaceutical manufacturing. Christine has given over 100 invited and keynote presentations and has served on multiple ICH working groups.

Vee joined Roche in 2013 and is a Chemist/PhD in Biochemistry, She worked for 36 years in EOF, the Medicines Authority of Greece, as Head of Division for over 15 years, 10 of them as Head of the GMDP Inspectorate of the Agency.

She led the implementation of a Quality System according to EU, PIC/S and ISO 17020 requirements in the Greek GMDP Inspectorate, the relevant Inspections methodology and the accession of EOF to PIC/S in 2002.

She has participated over 25 years in EU meetings in Brussels and in the EMA in London. Between 2002 and 2013 she represented EOF / Greece in the PIC/S Committee and has been a member of its Executive Bureau, more specifically as Chair of Compliance Group (monitoring new applications at PIC/S). She was involved in several Inspectorates’ PIC/S and EU assessment Teams (US FDA, Romania, Austria, Cyprus, Iran, Uganda, Armenia, UNICEF) and was involved at the EU-Japan MRA in 2002-2003.

She performed GMP inspections with EDQM and WHO Prequalification Program in India and China and participated in missions of the “Assistance to CFDA” project by WHO/Global Fund

Michelle Peake has been working in the field of biotechnology for over 20 years, for companies in Australia, England, Malaysia and Indonesia. She has worked in all areas from research, to process development, with her main experience in cGMP manufacturing for biopharmaceuticals. She has extensive experience in protein purification, tech transfer and fill/finish. In December 2003 Michelle was appointed as the Director of Manufacturing for Alpha Biologics, a biopharmaceutical CMO in Penang, Malaysia, where she was responsible for the design and construction of the Alpha cGMP facility and equipment and establishment of the company. Currently she is Senior General Manager at Kalbio Global Medika in Cikarang, Indonesia where she is responsible for multiple functions including QA, finance and business development.