Agenda

09:00
Opening Remarks from ISPE Singapore

09:10
Ensuring the Quality of Supply 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, Biologics CMC Development, Tech Transfer, Scale-up & Clinical Manufacturing, WuXi Biologics, China

10:25
Government Address: The Move Towards Pharma 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 Distributions

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

Track B: Process Validation

Track C: Sterile and Aseptic Operations

11:30
1. Managing Temperature Controlled Transportation

Kamaljit Hunjan. Senior Vice President, Global Healthcare, Ceva Logistics, UK

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

  • Addressing the challenges and opportunities in building up 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
1. Risk Assessment for Aseptic Processing

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

12:00
2. JIT Delivery to Reduce Costs and Improve Profitability (suggested)
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, US

12:00
2. Suggested Topics:

  • Best Practices in Bioburden Control in Sterile Manufacturing Cleanrooms
  • GMP Guidelines for Aseptic Processing and Operations

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

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

Panellists:
Thomas Halfmann, Partner, Halfmann Goetsch Partner AG, Switzerland
Paolo Rampichini, Head Supply Chain, Pharma, Asia Pacific, Hoffmann-La Roche
Senior Representative, Kuehne + Nagel

12:30
3. Panel Discussion: Transitioning from Project to Validation

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

Panellists:
George Kaliviotis, Senior Operations Start-Up Manager, Cell Culture & Central Services, AbbVie Operations Singapore Pte Ltd, Singapore

 

12:30
3. 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

Track B: Process Validation

Track C: Sterile and Aseptic Operations

14:15
1. 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 Contril 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, Senior Director Global Accounts, Werum IT Solutions, Germany

14:15
4. Workshop

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

14:15
4. 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
2. 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
5. Contained Powder for Handling for Sterile and/or Toxic Applications

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

15:15
3. Trevor Schoerie, Managing Director, PharmOut Pty Ltd, Australia

15:15
5. Current Manufacturing Industry Assessment on Process Validation Capabilities (suggested)

Ameet Ambarkhane, Lead Engineer, Global Technical Operations, MSD, Singapore

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

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

15:45
Afternoon Refreshments

15:45
Afternoon Refreshments

15:45
Afternoon Refreshments

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

Moderator: David Bartlett, 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
Frances Zipp, President and Chief Executive Officer, Lachman Consultant Service, USA
Ee Lynn Kok, Director, Enterprise Regulatory Compliance, Johnson & Johnson

16:30
6. Cleaning Cycle Development for Parts Washer

Richard Chai, Technical Service Manager, STERIS Corporation, Singapore

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

Mehul Patel, Global Director of Training, Charles River Endotoxin and Microbial Detection Singapore Pte Ltd., Singapore

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

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

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

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

17:30
PharmaNite Networking in Exhibit Hall
ISPE Regional Student Poster Competition Awards
Women in Pharma Reception / Talk

19:00
End of Day One and PharmaNite

Track D: Regulatory and Compliance

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

Track E: GAMP/Data Integrity and Industry 4.0

Chair:
Frances Zipp, President and Chief Executive Officer, Lachman Consultant Service, USA

Track F (AM): Product Transfer

09:00
Fireside Chat:

Vee Revithi, Ex-Head of EOF/Greece GMDP Inspectorate and Ex-External Relations Europe, Greece
Bob Tribe, Asia Pacific Regulatory Affairs Advisor, ISPE, former Chairman, PIC/S, Australia
Dr Vasiliki (Vee) Revithi, Ex-Head of EOF/Greece GMDP Inspectorate

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

Frances Zipp, President & CEO, Lachman Consultant Services, USA

09:00
1. 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
2. Regulatory Updates:

Vladimir Orlov, Deputy Head, Educational Center for Good Practices, State Institute of Drugs and Good Practices, Russia
Chong Hock Sia, Senior Consultant, Audit & Licensing, Director, Quality Assurance, Health
Products Regulation Group, Health Sciences Authority, Singapore

09:30
2. Comparison of the New MHRA DI Guideline

Valeria Frigerio Regazzoni, Global Head of Quality Auditor & Consultant Group, Merck Group, Switzerland

09:30
2. 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

10:00
3. 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
3. Computational Fluid Dynamic Simulation of Bioreactors to Assess Technology Transfer

Albert Dyrness, Chief Technology Officer, ADVENT Engineering, US

10:30
3. Followed by Panel Discussion: Speakers joined by HSA, Thai FDA, Indonesia

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

Panellists:
Chong Hock Sia, Senior Consultant, Audit & Licensing, Director, Quality Assurance, Health Products Regulation Group, Health Sciences Authority, Singapore
Dr Vasiliki (Vee) Revithi, Ex-Head of EOF/Greece GMDP Inspectorate

10:30
4. Developing and Implementing an Effective Technology and Product Transfer Plan (suggested)

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

11:15
Morning Tea

11:15
Morning Tea

11:15
Morning Tea

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

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

11:45
4. 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
5. 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
5. Quality in Focus Panel Discussion:

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

Panellists:
Georg Singewald, Head Quality, Asia Pacific, Solids & Special Technologies, Novartis, Singapore
Sook Peng Chua, ASEAN Regulatory & Quality Compliance Director, J&J and ISPE Exco member, Singapore

12:20
5. 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
6. Panel Discussion: Managing Challenges of Scale-up, GMP, Risk Assessments

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

Awaiting final confirmation
Albert Dyrness, Chief Technology Officer, ADVENT Engineering, US

13:00
Lunch

13:00
Lunch

13:00
Lunch

Track D: Regulatory and Compliance

Track E: GAMP/Data Integrity and Industry 4.0

Track F (PM): Single Use Systems

14:15
6. Quality Management and Compliance Challenges Associated with the Advanced Therapy Medicinal Products

14:15
6. Validation, Reducing Errors, Improve Data Decisions by Integrating Operations and QC Devices

Felix Mausolf, Regional Sales Manager, Groninger, Germany

14:15
1. Future Biomanufacturing–Balancing Clean And Reuse, Single-Use And Continuous Technologies

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

15:00
7. Managing Regulatory Inspections and Audits

15:00
7. MES & Data Integrity 

Thomas HalfmannPartner, Halfmann Goetsch Partner AG, Switzerland

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

Sim Li Jun, Technology Manager, Singapore & Malaysia, Biologics Lead-Southeast Asia, Merck Pte Ltd, Singapore

15:30
Afternoon Refreshments and Passport Draw

15:30
Afternoon Refreshments and Passport Draw

15:30
Afternoon Refreshments and Passport Draw

16:00
8. Case Study: New Facility Design, Construction and Compliance

Mehul Patel, Senior Compliance Consultant, Commissioning Agents International (CAI)

16:00
8. 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
3. Cleaning Validation Strategy and Cleaning Method to Apply of Stainless Steel Equipment

Dr. Jincai Li, Vice President, Biologics CMC Development, Tech Transfer, Scale-up & Clinical Manufacturing, WuXi Biologics, China

16:30
9. Case Study: The New Roles of Compliance Team with the Goals of Performance and Regulatory Compliant (suggested)

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

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

Elad Mark, Technical Project Manager, Process, Novartis, Singapore

17:00
10. Quality and Regulatory Compliance Risk Management

17:00
10. Round up Q&A session with speakers

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

Moderator: Elad Mark, Technical Project Manager, Process, Novartis, Singapore

Panellists:
Denise Tan, Principal Engineer, Process Development, Amgen, Singapore
Qiwei Wu, Vice President of Process Development and Manufacturing, Livzon Mabpharma Inc., China

17:30
Close of Conference

17:30
Close of Conference

17:30
Close of Conference

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