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CONFERENCE AND EXHIBITIONTechnology Innovations, Improving Healthcare
“The ISPE conference is an excellent way to get energised to deliver value to my organization. I feel confident in the implementation of concepts I learnt here”Catherine Le Denmat, Associate Engineer, MSD
Organised By
21 - 23 AUGUST 2019 I SUNTEC SINGAPORE
KeynotesMelissa Guan Head of Healthcare Economic Development Board, Singapore
Dr. Christiane Hamacher Chief Executive Officer Biocon Biologics India
www.ispesingapore.org
1000+PARTICIPANTS
65+SPEAKERS
25+COUNTRIES
6TRACKS
19YEARS IN SINGAPORE
NEW IN 2019!
CLEANING AND VALIDATION, AND TECH TRANSFER
QUALITY AND COMPLIANCE
MANUFACTURING FOR CELL AND GENE THERAPY
ASEPTIC OPERATIONS
LEAN AND OPERATIONAL EXCELLENCE
PROJECT MANAGEMENT / ENVIRONMENT,
HEALTH AND SAFETY
PHARMA 4.0, DATA INTEGRITY
& GAMP
CONFERENCE AND EXHIBITION
Technology Innovations, Improving Healthcare
21 - 23 AUGUST 2019 SUNTEC SINGAPORE
AGENDA AT A GLANCE:
CLOSE OF CONFERENCE
Dr. Toru J Seo Senior Director and APAC Head, Search and Evaluation, Worldwide Business Development, Chief Business Office Pfizer Inc., Japan
Dr. Gang Wang Vice President, Quality WuXi Biologics, China
Danee Zainal Head of Manufacturing Alcon, Indonesia
Christian Cater Head of Operational Excellence Roche, Singapore
Vladimir Orlov Deputy Head State Institute of Drugs and Good Practices Russia
Dr. Georg Singewald Head of Global Quality Control, VP Roche, Switzerland
Jennifer Cheung Head of External Relations Asia Pacific & Global Compliance Business Solutions Genentech, United States
Hazem Eleskandarani Project Director, Engineering & Property Services Johnson & Johnson, United States
Farooq Mustafa Chaudhry Associate Director, Quality Operations & Biotech Macter International, Pakistan
Dr. Sannie Chong Head of Asia Pacific Tech Regulatory Policy - Singapore Technical Operations Roche, Singapore
Wu Tai Jung Director of Production Technology Division GONGWIN Biopharm, Taiwan
Simone Hurly Automation Engineer MSD, South Africa
Steve Oh Institute Professor/Scientist A*STAR, Singapore
Nirmal Kumar Head of Quality Assurance Novugen Pharma, Malaysia
Chai Chong Meng Head of Mammalian Manufacturing Lonza Biologics, Singapore
Anna Koay Director of EHSS Amgen, Singapore
Dr. Susanna Nagel Quality Site Head Roche, Singapore
Dr. Syed Abid Hassan Head Regulatory Compliance; Team Leader – Variation Management Committee, Jamjoom Pharmaceuticals Company, Saudi Arabia
Pierre Winnepenninckx ISPE Singapore Conference Chair, Singapore
Arnel Cabungcal Assistant Vice President – Manufacturing United Laboratories Inc, Philippines
Lathalu Krishnamoorthy Quality Assurance Manager ICM Pharma, Singapore
Kartik Kulbhushan Global Head and Vice President for Operations Strategy and Transformation Dr. Reddy’s Laboratories, India
Suyamburam Sathasivam Senior General Manager and Head of External Manufacturing Biologics Sun Pharma, India
Dr. Victor Li, Co-founder and Chairman, Lion TCR, Founder and CEO, BioSyngen, Singapore
Dinar Wahyuni Quality Assurance Executive Strides Pharma, Singapore
Chandrakant Bhandare Head of Quality Zydus Cadila Myanmar Myanmar
Jose Luis Narvaez Plant Director United Laboratories, Inc. Vietnam
Rodel Sibulo Director Pharma Project Operations - Deputy General Director Nanogen Pharmaceutical Biotechnology Joint Stock Company, Vietnam
Ting-Yuan Tan QA Senior Specialist, ASQ Certified Quality Auditor JHL Biotechnology, Taiwan
Wan Mohd Nazeem Wan Asharuddin, Senior EHS Manager Biocon Sdn. Bhd., Malaysia
Michelle Peake Senior General Manager PT Kalbio Global Medika, Indonesia
Kelly Keen, Vice President Project Management, Head of PMO, Celonic, Switzerland
Ruchir Umalkar Deputy General Manager- Process Development and Technical Services Mylan, India
Dr. Harleen Kaur Senior Research Scientist-I Aurobindo Biologics, India
Paul Tan Head of Manufacturing Excellence, Biologics Takeda Pharmaceuticals, Singapore
James Weidner Executive Director of Process Development Amgen, Singapore
Benjamin Sauer Site Technical and Portfolio Lead AstraZeneca, Australia
Stephen Shi Lean Six Sigma Director Fosun Pharma, China
Srinivasa Rao Sambangi Senior General Manager Aurobindo Pharma, India
Isa Hamzah Asia-Pacific Integrated Manufacturing Excellence Deployment Leader Pfizer, Singapore
Maurice Parlane, ISPE PV Chapter Lead, Director, ISPE Australasia & Director, Centre for Biopharmaceutical Excellence, Australia
Teo Szu Hui Site Facility Lead Novartis, Singapore
Dr. Xiaoping Cao, Vice President and Head of CMC and Supply Chain, Cerecin, Singapore
www.ispesingapore.org
MANAGED BY:
ORGANISED BY:
EXHIBITORS:
SPONSORS AND EXHIBITORS
ASSOCIATE SPONSORS: PARTNER:
O P T I O N S A N D S O L U T I O N S
®
TRACK SPONSOR:
21 AUGUST - PRE-CONFERENCE WORKSHOPS
WOMEN IN PHARMA LUNCHPHARMANITE NETWORKING
YOUNG PROFESSIONALS NETWORKING
COMMISSIONING & QUALIFICATION (C&Q), AND NEW GUIDE LINES
STATISTICS FOR CONTINUED PROCESS VERIFICATION (CPV)
TRACK A PHARMA 4.0 (AM)
DATA INTEGRITY AND GAMP (PM)
TRACK BPROJECT MANAGEMENT (AM) ENVIRONMENT, HEALTH AND
SAFETY (PM)
TRACK CASEPTIC OPERATIONS (AM)
MANUFACTURING FOR CELL AND GENE THERAPY (PM)
22 AUGUST - MAIN CONFERENCE DAY 1
TRACK D QUALITY AND COMPLIANCE
TRACK E LEAN AND OPERATIONAL EXCELLENCE
TRACK F CLEANING AND VALIDATION (AM)
TECH TRANSFER (PM)
23 AUGUST - MAIN CONFERENCE DAY 2
STELLAR LINE-UP OF GLOBAL PHARMA MANUFACTURERS AND EXPERTS
Women in Pharma (WIP)
Young Professionals
in Pharma (YP)
40+Manufacturers Case Studies
SUPPORTING ASSOCIATIONS:
NETWORKING COCKTAIL SPONSOR
SPONSORS:
Technology Innovations, Improving Healthcare
21 - 23 AUGUST 2019 SUNTEC SINGAPORECONFERENCE AND EXHIBITION
MAIN CONFERENCE DAY 1: 22 AUGUST 2019, THURSDAY
10:45 Opening of ISPE Singapore Exhibition and Morning Refreshments
15:45 Afternoon Refreshments
09:00 Opening Remarks from ISPE SingaporeJoseph Micsko, President, ISPE Singapore Affiliate
09:10 GOVERNMENT ADDRESS: Harnessing the Full Potential of Pharma 4.0Melissa Guan, Head, Healthcare, Economic Development Board, Singapore
09:30 LEADERSHIP KEYNOTE ADDRESS: Driving Innovation for Affordability and Access of MedicinesDr. Christiane Hamacher, CEO, Biocon Biologics Limited, India
10:00 PANEL DISCUSSION: Asia’s Role in Delivering Affordable Quality HealthcareModerator:Pierre Winnepenninckx, ISPE Singapore Conference Chair, SingaporePanellists:Chai Chong Meng, Head of Mammalian Manufacturing, Lonza Biologics, SingaporeDr. Christiane Hamacher, CEO, Biocon Biologics, IndiaDr. Georg Singewald, Head of Global Quality Control, VP, Roche, SwitzerlandVladimir Orlov, Deputy Head of Scientific, Methodology & Training Dept, FSI State Institute of Drugs and Good Practices, Russia
Opening Plenary Sessions
11:30 Transformation Of The Pharma Value Chain With Industry 4.0Kartik Kulbhushan, Global Head and Vice President for Operations Strategy and Transformation, Dr. Reddy’s Laboratories, India
11:30 Project Management Continuous Improvement: Lessons Learned ProcessHazem Eleskandarani, Project Director, Engineering & Property Services, Johnson & Johnson, United States
11:30 Strategies to Keep Parenteral Drug Products Free From Particulate Matter Contamination• Introduction to visible particles’ contamination in parenteral drugs• Adverse effects caused by visible particles• Sources of visible particles• Detection and identification of visible particles• Strategies of effective control of visible particles’ contaminationFarooq Mustafa Chaudhry, Associate Director, Quality Operations & Biotech, Macter International Ltd., Pakistan
12:00 Collaboration and Alliance Through “Open Innovation”Dr. Toru J Seo, Senior Director and APAC Head, Search and Evaluation, Worldwide Business Development, Chief Business Office, Pfizer Inc., Japan
12:00 GMP Compliance Project – From the Client Prospective • Communication management, stakeholder engagement and scope
definition • Case Study: A complicated, fast track HVAC upgrade project
packaging facility into a successful qualification of the facility• Forming cohesive project team with the tools to deliver and allowing
for the resumption of supply chain of critical medicines for the regionSimone Hurly, Automation Engineer, MSD, South AfricaMorgan O’Brien, Business Development Manager, No Deviation Pte Ltd, Singapore
12:00 Aseptic Process Sampling Risk Mitigation• Complexity and risks of traditional sampling methods• Key drivers for aseptic process sampling• Regulatory recommendations and corresponding needs• Key considerations for optimizing sampling plan and best sampling
optionsLi Jun Sim, Technology Manager, Biologics Lead, Merck Life Sciences, Singapore
12:30 How Can Automation and Digital Data Improve Speed to Market?• What makes a great data set for a data scientist or process engineer? • Where are the challenges for data users with automation design?• What attributes of automation design make for seamless analytics?Jacqueline Hora, Digital and Data Consultant, Zenith Technologies, Ireland
12:30 Amgen’s Case Study: Optimising Process Improvement Within Design Space CapabilitiesJames Weidner, Executive Director of Process Development, Amgen, Singapore
12:30 Designing a Contamination Control Strategy in an Aseptic FacilityBenjamin Sauer, Site Technical and Portfolio Lead, AstraZeneca, Australia
TRACK A (AM): PHARMA 4.0Chairman: Chua Wee Ming, Managing Director, HGP Asia Pte Ltd at Halfmann
Goetsch Partner AG, Singapore
TRACK B1 (AM): PROJECT MANAGEMENTChairman: Pierre Winnepenninckx, ISPE Singapore Conference Chair, Singapore
TRACK C (AM): ASEPTIC OPERATIONSChairman:
15:15 PANEL DISCUSSION: Pharma 4.0 – Addressing Opportunities and Challenges Moderator:Chua Wee Ming, Managing Director, HGP Asia Pte Ltd at Halfmann Goetsch Partner AG, SingaporePanellists: Dr. Toru J Seo, Senior Director and APAC Head, Search and Evaluation, Worldwide Business Development, Chief Business Office, Pfizer Inc., JapanKartik Kulbhushan, Global Head and Vice President for Operations Strategy and Transformation, Dr. Reddy’s Laboratories, India James Weidner, Executive Director of Process Development, Amgen, SingaporeDr. Xiaoping Cao, Vice President and Head of CMC and Supply Chain, Cerecin, Singapore
15:15 Cell and Gene Therapy: Overcoming Constraints in Scalability, Sustainability and Cost of GoodsAndy Rayner, Pharma Sector Director and CTO, PM Group, United States
14:15 Machine Learning in Pharmaceutical Process Development: Where are we up to in Pharma 4.0? • Comparison of current AL and ML approaches with well-established
alternative techniques in the process industries: Advanced Process Control (APC) and Multi-Variate Analysis
• Case studies on the application of ML for process control and optimization
David Lovett, Managing Director, Perceptive Engineering Ltd., Singapore
14:15 Operational Excellence and Lean Six Sigma For Pharma Plant Design• Enablers of incorporating Operational Excellence and Lean into Plant
Design Phase in Project Management• Physical vs. cultural factors• Common flaws in assumption based on product volume/product mix/
capital investment approved/budget• How can we overcome this to ensure that when the site goes into full
operational phase, the processes are lean and meeting operational excellence KPI such as good throughput time, with an optimized work force?
Teo Szu Hui, Site Facility Lead, Novartis, Singapore
14:45 The Importance of Culture in Project and Portfolio Management During Mergers and Acquisitions • Brief introduction of speaker’s experience in Roche’s buyout of
Genentech in 2009 and Celonic’s acquisition of Glycotope in Heidelberg, Germany
• Experiences, lessons learned and risks at different levels Kelly Keen, Vice President Project Management, Head of PMO, Celonic, Switzerland
14:15 Moist Heat Sterilizators: From Sterilization Theory to no Deviation Design Dr. Chem. Eng. Vittorio Mascherpa, Senior R&D Consultant, Fedegari Group, Italy
14:45 CASE STUDY: Data Integrity in Pharma 4.0• Why is data integrity important?• Data Integrity in Industry 4.0: How to stay relevant in the new age?• Overview of ALCOA principles• Data Integrity Framework: How to integrate/implement data integrity
into business functions?• Leading vs. lagging indicators of data integrityDanee Zainal, Head of Manufacturing, Alcon, Indonesia
15:15 PANEL DISCUSSION: Pharma Outsourcing and Project Management Moderator:Pierre Winnepenninckx, ISPE Singapore Conference Chair, SingaporePanellists: Hazem Eleskandarani, Project Director, Engineering & Property Services, Johnson & Johnson, United States Simone Hurly, Automation Engineer, MSD, South AfricaKelly Keen, Vice President Project Management, Head of PMO, Celonic, SwitzerlandTeo Szu Hui, Site Facility Lead, Novartis, Singapore
14:45 Beyond the Dating Game: Serious Supplier Relationships in the Adoption of Single-Use Technologies• Drivers for rapid emergence and adoption of single-use technologies • Challenges in the evolving relationship between component suppliers
and pharmaceutical manufacturers, as they shift away from traditional stainless steel systems
• Guidelines for vendor selection, and re-defining the rules of engagement for ongoing interaction
Stephen Doherty, Global Director, Business Development, Garlock Hygienic Technologies, United Kingdom
TRACK A (PM): PHARMA 4.0Chairman: Chua Wee Ming, Managing Director, HGP Asia Pte Ltd at Halfmann
Goetsch Partner AG, Singapore
TRACK C (PM): MANUFACTURING FOR CELL AND GENE THERAPY
Chairman: Ief Leroy, Managing Partner, VILS, Belgium
16:25 Building a Pharmaceutical Safety Culture• How is EHS in pharma different from other industries?• Factors to consider for a well-designed and comprehensive EHS
program, and a contingency plan• How to strengthen quality culture in your pharma business?Wan Mohd Nazeem Wan Asharuddin, Senior EHS Manager, Biocon Sdn. Bhd, Malaysia
16:25 Meeting Data Integrity Requirements in Asean• Implementing a robust data integrity program within Zydus Cadila • Compliance with ASEAN GMP• Progress and challenges of data integrity in MyanmarChandrakant Bhandare, Head of Quality, Zydus Cadila Myanmar, Myanmar
17:10 Improving Safety in The Next-Generation Biomanufacturing Plant – is There a Difference? • Perspective of safety in the Next-Generation Biomanufacturing Plant • Four critical pillars for proven safety successAnna Koay, Director of EHSS, Amgen, Singapore
16:50 Effective Contractor Safety Management • Critical success factors and minimum requirements required to lead safety • Overview of how different elements can be applied to influence
perception of safety within workforce • Overview of the Full Range leadership model, and practical application
of the Model to safety Craig Docherty, CEO/Founder, Fusion Safety Management, Australia
16:25 Scaling up the Cell Therapy Manufacturing Process• Overview of flowchart for the cell therapy manufacturing process• Current manufacturing models for stem cell therapies, and regulatory
challenges• Advancements in bioprocessing tech for stem cell therapy
manufacturingDr. Steve Oh, Institute Scientist / Professor, A*STAR, Singapore
16:55 Auditing for Data Integrity: Expectations of Regulators and Experience of QA Audits• Requirements for data integrity audit• Expectations of regulators and GLP inspectors, and role of QA in
ensuring complianceDr. Labhu Sanghani, Director of Global Quality Assurance, Jai Research Foundation (JRF Global), India
17:30 Ten Most Common Occupational Health and Safety Audit Findings from High-Potency API Facilities in the Developing World• Overview of emerging markets for manufacturing HPAPIs• Most common occupational health and safety audit findingsDean Calhoun, President/CEO, Affygility Solutions, United States
16:55 Lion TCR’s Strategy for T Cell Therapy ManufacturingDr. Victor Li, Co-founder and Chairman, Lion TCR, Founder and CEO, BioSyngen, Singapore
17:30 PANEL DISCUSSION: Ensuring Data and Product Quality for Patient Safety Moderator:Chua Wee Ming, Managing Director, HGP Asia Pte Ltd at Halfmann Goetsch Partner AG, SingaporePanellists:Dr. Nirmal Kumar, Head of Quality Assurance, Novugen Pharma, Malaysia Holger Linnertz, Head of Software Development Factory, Mettler-Toledo (S) Pte Ltd., SwitzerlandJennifer Cheung, Head of External Relations Asia Pacific & Global Compliance Business Solutions, Genentech, United States
17:30 CGMP Considerations for the Design and Operation of Cell Therapy FacilitiesFrancesca McBride, Director of Regulatory Compliance, Jacobs Engineering, United States
TRACK A (PM): DATA INTEGRITY AND GAMPChairman: Chua Wee Ming, Managing Director, HGP Asia Pte Ltd at Halfmann
Goetsch Partner AG, Singapore
TRACK B2 (PM): ENVIRONMENT, HEALTH AND SAFETY (EHS)
Chairman: Thomas Terranova, Managing Director, Terra Asia Consulting, Singapore
TRACK C (PM): MANUFACTURING FOR CELL AND GENE THERAPY
Chairman: Ief Leroy, Managing Partner, VILS, Belgium
13:00 Lunch in the Exhibition Hall 13:00 Women in Pharma Brainstorming Lunch & Talk
18:00 Pharmanite Networking18:00 - 19:00 Pharmanite Networking
MAIN CONFERENCE DAY 2: 23 AUGUST 2019, FRIDAY
16:15 PANEL DISCUSSION: Quality, Compliance and SustainabilityModerator:Dr. Georg Singewald, Head of Global Quality Control, VP, Roche, SwitzerlandPanellists: Ting-Yuan Tan, QA Senior Specialist, ASQ Certified Quality Auditor, JHL Biotechnology, TaiwanDanee Zainal, Head of Manufacturing, Alcon, IndonesiaDr. Syed Abid Hassan, Head Regulatory Compliance; Team Leader – Variation Management Committee, Jamjoom Pharmaceuticals Company, Saudi ArabiaDr. Nirmal Kumar, Head, Quality Assurance, Novugen Pharma, Malaysia
16:15 PANEL DISCUSSION: Creating and Managing an Operational Excellence Management SystemModerator:Benjamin Sauer, Site Technical and Portfolio Lead, AstraZeneca, AustraliaPanellists:Rodel Sibulo, Director Pharma Project Operations - Deputy General Director, Nanogen Pharmaceutical Biotechnology Joint Stock Company, VietnamSrinivasa Rao Sambangi, Senior General Manager, Aurobindo Pharma, IndiaArnel Cabungcal, Assistant Vice President - Manufacturing, United Laboratories Inc, Philippines
16:15 Combined Q&A Session
15:45 Digital-Let the Water Experts Monitor, Manage and Improve the Operation of your Compendial Water SystemsRanj Rihal, Pharmaceutical and Cosmetics Business Development, Veolia Water Technologies, United Kingdom
15:45 Risk Management and Endotoxin Control in Biopharmaceutical Manufacturing• Review of the dynamic nature of lipopolysaccharide fine structures
and how these structures are associated with gram negative bacteria survival strategies
• Process deviations and root cause recommendations that may facilitate investigations to alert or action level excursions
• Tools used to track and/or trend critical systems that enable a state of environmental control
John Dubczak, General Manager, Operations Management, Charles River Laboratories, Microbial Solution, United States
15:45 Best Practices for Effective Tech Transfer - From R&D to Clinical to CommercialModerator: Liu Shan Shan, ISPE Singapore Vice President, SingaporePanellists:Wu Tai Jung, Director of Production Technology Division, GONGWIN Biopharm, TaiwanSuyamburam Sathasivam, Senior General Manager and Head of External Manufacturing Biologics, Sun Pharma, DubaiDr. Harleen Kaur, Senior Research Scientist-I, Aurobindo Biologics, India
14:45 Comparative Review of Quality Compliance for Pharma Manufacturing and Distribution• Review of how GMPs have evolved• Continuous improvement in quality risk management: A need for a
Holistic Approach • Role of tech in balancing GxP compliance and productivityDr. Nirmal Kumar, Head, Quality Assurance, Novugen Pharma, Malaysia
14:45 Continuous On-Line Microbial Monitoring for Pharmaceutical Waters• Overview of 7000RMS principle of operation• Industry’s drive for online rapid microbial detection• Examples of 7000RMS customer dataAkash Trivedi, Product Manager, Mettler-Toledo (S) Pte Ltd., United States
14:45 Navigating Regulatory and Compliance Issues Surrounding Tech TransferDr. Harleen Kaur, Senior Research Scientist-I, Aurobindo Biologics, India
14:15 Building an Integrated Quality System in Pharma Commercial Manufacturing• Compliance with ICH Q10 regulatory• Approach in implementing an effective QMS• Implication of industry trends and tech for QMSDinar Wahyuni, Quality Assurance Executive, Strides Pharma, Singapore
14:15 Human Behavioural Root Causes and CAPA • Using real data and decision trees to practice behavioral root cause
analysis, CAPA formulation and continuous improvement efforts Harry Benson, Global Director, Human Performance Services, CAI, United States
14:15 Sun Pharma’s Experience in Tech Transfer for Biologics• Critical steps for a successful tech transfer process• Risk management in the tech transfer of biologics• Overcoming challenges of biologics process transferSuyamburam Sathasivam, Senior General Manager and Head of External Manufacturing Biologics, Sun Pharma, Dubai
13:45 Supplier Quality Management for Pharma• Risk assessment application in supplier management• Third party deviation handling• Auditor qualificationTing-Yuan Tan, QA Senior Specialist, ASQ Certified Quality Auditor, JHL Biotechnology, Taiwan
13:45 CASE STUDY: Operational Excellence in Pharma R&DStephen Shi, Lean Six Sigma Director, Fosun Pharma, China
13:45 Product Transfer Case Study on PTS Anti-Cancer Drug: World’s First Targeted Chemo-Ablation• Experience sharing from Gongwin on tech transfer success with CMO
partner • Current landscape for local production and tech transfer in Taiwan,
China and the US• Key factors to consider ensuring successful tech transfers, and how to
address roadblocksWu Tai Jung, Director of Production Technology Division, GONGWIN Biopharm, Taiwan
12:00 Challenges and Achievements With Drug Regulation in the GCC Region• How has regulatory compliance evolved in the Middle East?• Overview of regulatory approval pathway in the MENA region• How does GCC’s approval system compare with SFDA, USFDA and the
EU?Dr. Syed Abid Hassan, Head Regulatory Compliance; Team Leader – Variation Management Committee, Jamjoom Pharmaceuticals Company, Saudi Arabia
12:00 Achieving Operational Excellence in End-to-End Pharma Supply Chain• Overview of Operational Excellence and Lean Management Principles • Hoshin-Kanri Policy Deployment • Success factors and Pitfalls of Operational Excellence execution Arnel Cabungcal, Assistant Vice President - Manufacturing, United Laboratories Inc, Philippines
12:00 PANEL DISCUSSION: Emerging Cleaning Technologies and InnovationsModerator:Maurice Parlane, ISPE PV Chapter Lead, Director, ISPE Australasia & Director, Centre for Biopharmaceutical Excellence, AustraliaPanellists:Christian Cater, Head of Operational Excellence, Roche, SingaporeMurugappan Karthick, Research Scientist, Institute of Chemical and Engineering Sciences, A*STAR, SingaporeLathalu Krishnamoorthy, Quality Control and Assurance Manager, ICM Pharma, SingaporeRichard Chai, Technical Service Manager, STERIS Corporation, Singapore
11:30 Breakthrough Ideas in Quality• Use of a Design Thinking approach to transform an over-engineered
process • Case Study on DMS/Change Management: Low Risk Discrepancies;
Redesign Technical Change Management Pilot • Case Study on Governance and Quality Oversight: Retirement of top-
down monitoring systems through implementation of DR&S / TableauDr. Susanna Nagel, Quality Site Head, Roche, Singapore
11:30 CASE STUDY: How Can Six Sigma Improve Big Pharma?• Application of Six Sigma in a Lean Production System• Application of Process Capability Indices in Pharma• Statistical Process Control – Where we went wrong and what to do
about it? Isa Hamzah, Asia-Pacific Integrated Manufacturing Excellence Deployment Leader, Pfizer, Singapore
11:30 Selecting the Right Sterile Connector for your Single-Use System• Overview of current market for sterile connectors• Key characteristics to look at when selecting sterile connectorRaymond Dallago, Director of Sales, SaniSure, United States
11:00 Manufacturing and QC Labs GMP Standalone Simple Equipment Compliance ProcessMansoor Mohammad, Director, Quality Assurance, Data Integrity and Quality Management System, Samsung Biologics, South Korea
11:00 CASE STUDY: Achieving Operational Excellence in Product Changeover Paul Tan, Head of Manufacturing Excellence, Biologics, Takeda Pharmaceuticals, Singapore
11:00 Contamination Control in Gmp Cleanrooms• Regulatory expectations related to contamination control• Causes of contamination in cleanroom • Effective strategies in bioburden control, cleaning and disinfectionRichard Chai, Technical Service Manager, STERIS Corporation, Singapore
10:00 Developing KPIS to Measure Regulatory Convergence of Asia-Pacific Economic Cooperation (APEC)• Evolution of regulatory harmonization, convergence and cooperation:
The ICH experience• Best practices and feasible processes for APEC economies’
convergence• Proposed KPIs to measure APEC regulatory convergence and
cooperation- Certificate of pharmaceutical product (CPP)- The pharmaceutical inspection co-operation scheme (PIC/S)
membership- Managing multiple sites in one license- Risk-based reliance evaluation system
• Capacity buildingDr. Sannie Chong, Head of Asia Pacific Tech Regulatory Policy - Singapore Technical Operation, Roche, Singapore
10:00 Role Of Leadership In Fostering Operational Excellence and Continuous ImprovementJose Luis Narvaez, Plant Director, United Laboratories Inc., Vietnam
10:00 Cleaning Validation for Pharmaceutical Products• Overview of cleaning validation protocol for cosmetic products• How much variation is acceptable in products and processes?• New techniques in designing cleaning processLathalu Krishnamoorthy, Quality Control and Assurance Manager, ICM Pharma, Singapore
09:30 Ensuring Quality Compliance in Tech TransferMichelle Peake, Senior General Manager, PT Kalbio Global Medika, Indonesi
09:30 Lean Principles for a Stronger Quality Management System• Identifying the requirements of customers and stakeholders• Value stream approach to identify and minimize waste and variations• Types of waste• Push system vs. Pull system• Continuous improvement culture and the role of employeesSrinivasa Rao Sambangi, Senior General Manager, Aurobindo Pharma, India
09:30 Understanding the Cleaning Phenomena in API Plants to Enable Cleaning by Design• Measurement of relevant material properties of APIs such as solubility,
strength of surface bonding • Flow rig to observe tokens under cleaning conditions • Evaluation of analytical technologies such as UV-Vis and Fluorescence
for wash liquor monitoring• Inspection technologies such as borescope and associated image
analysisMurugappan Karthick, Research Scientist, Institute of Chemical and Engineering Sciences, A*STAR, Singapore
09:00 CMC Regulatory Compliance for BiologicsDr. Gang Wang, Vice President, Quality, WuXi Biologics, China
09:00 Applied Operational Excellence in Pharmaceutical ManufacturingRodel Sibulo, Director Pharma Project Operations - Deputy General Director, Nanogen Pharmaceutical Biotechnology Joint Stock Company, Vietnam
09:00 Statistical Approaches in Product Validation • Introduction to equivalence testing, and surrounding regulatory frameworks• Importance of equivalence testing• Where is equivalence needed: product transfers and method validations• Examples of equivalence testingChristian Cater, Head of Operational Excellence, Roche, Singapore
TRACK D (AM): QUALITY AND COMPLIANCEChairman: Dr. Georg Singewald, Head of Global Quality Control,
VP, Roche, Switzerland
TRACK E (AM): LEAN AND OPERATIONAL EXCELLENCEChairman: Benjamin Sauer, Site Technical and Portfolio Lead, AstraZeneca,
Australia
TRACK F (AM): CLEANING AND VALIDATIONChairman: Maurice Parlane, ISPE PV Chapter Lead, ISPE Australasia & Director,
Centre for Biopharmaceutical Excellence, Australia
10:30 Morning Tea
12:30 Lunch
TRACK D (PM): QUALITY AND COMPLIANCEChairman: Dr. Georg Singewald, Head of Global Quality Control,
VP, Roche, Switzerland
TRACK E (PM): LEAN AND OPERATIONAL EXCELLENCEChairman: Benjamin Sauer, Site Technical and Portfolio Lead, AstraZeneca,
Australia
TRACK G (PM): TECH TRANSFERChairman: Liu Shan Shan, ISPE Singapore Vice President, Singapore
15:15 Afternoon Refreshments
17:00 Close of Conference17:00 Happy Hour & Young Professionals (YP) Networking
www.ispesingapore.org
Technology Innovations, Improving Healthcare
21 - 23 AUGUST 2019 SUNTEC SINGAPORECONFERENCE AND EXHIBITION
www.ispesingapore.org
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To discuss opportunities for raising your brand profile Contact: Yvonne LeongT: +65 6508 2489 E: [email protected]
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1ST TIME! HAPPY HOUR & YOUNG PROFESSIONALS (YP) NETWORKING
23 August 2019, 5:00pm till late, Paulaner Brauhaus
All are welcome to join this informal gathering, after our annual conference winds down.
Whether you’re a young or seasoned professional, this is a great opportunity to engage with friends and peers over an ice cold beer. Show your ISPE entry pass and the first drink is on us!
ALL ARE WELCOME!
WOMEN IN PHARMA (WIP) BRAINSTORMING LUNCH & TALK
Thursday, 22 August 2019, 1:00PM to 2:15PMWear your Women in Pharma pin for entry OR by S$15 minimum donation to Women in Pharma Foundation. Available at registration, ISPE and CAI stands.
Engage with inspiring women leaders in this interactive lunch discussion facilitated by our affiliate’s Women in pharma committee!
All are welcome, pre-register or join on-site subject to seat availability.
21 AUGUST - PRE-CONFERENCE WORKSHOPS
PRE-CONFERENCE WORKSHOP 1, 9:00AM TO 1:00PM
HANDS-ON IMPLEMENTATION OF RISK-BASED QUALIFICATRION FOLLOWING THE NEW ISPE BASELINE GUIDEHazem Eleskandarani, Project Director, Engineering & Property Services, Johnson & Johnson, United StatesPierre Winnepenninckx, ISPE Singapore Conference Chair, Singapore
PRE-CONFERENCE WORKSHOP 2, 9:00AM TO 1:00PM
ROOT CAUSE ANALYSIS AND CAPAMaurice Parlane, ISPE PV Chapter Lead, Director, ISPE Australasia & Director, Centre for Biopharmaceutical Excellence, Australia
ISPE STUDENT HACKATHON - CALLING STUDENTS AND YOUNG PROFESSIONALS*!*Students may be Undergraduates or Post-graduate; Young Professionals (YPs) are members with up to 5 years’ industry experience.
DINNER SPONSORED BY FEDEGARI GROUP
Dear industry colleaguesAs the industry innovates at breakneck speed, best practice is being continually refined in all aspects of manufacturing. ISPE Singapore Affiliate, through its annual conference, is pleased to once again offer you a learning and networking opportunity like no other in Singapore.
With a record 1000+ participants, the ISPE Singapore Conference and Exhibition broke new ground in 2018.
We saw a strong presence of Pharma and Manufacturers, supported in equal measure by Regulators, EPCM, and various other stakeholders and service providers.
Industry support by itself is our testament to quality, and we promise an even better, newer and value packed three days for your benefit.
Do make the time to come with your teams. I am confident it will generate great learning value for your organisation.
I look forward to meeting you on the day.
With regards,
Pierre WinnepenninckxChair ISPE Singapore Conference 2019
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RegistrationMain Entranceto Exhibit Hall
Available
Sold
Reserved
MEDIA PARTNERS:
EXCLUSIVE
21 - 22 August 2019 9:00am-7:00pm All participants will receive a real-world, industry-relevant case study prior to the beginning of the Hackathon. Industry professionals will judge the presentations. Teams will be tasked with developing a solution to their respective challenge and present it to judges on 22 August.
Winners will be announced later that day at Pharmanite.
NEW!
Thursday, 22 August 20197:30pm | Otto Ristorante
5 EASY WAYS TO REGISTER:MAIL the attached registration form with your cheque to: IBC Asia (S) Pte Ltd, c/o Informa Regional Business Services, 103 Penang Road, Visioncrest Commercial #04-01, Singapore, 238467
Customer Service Hotline: +65 6508 2401
Email: [email protected]
Web: www.ispesingapore.org
Fax: +65 6508 2407
ISPE SINGAPORE ANNUAL CONFERENCE 2019
REG
NO
. 200
1082
03N
P46388 / IA53D
(Please photocopy for additional delegates)
Payment Method (Please tick:) I enclose my Cheque/Draft payable to IBC Asia (S) Pte Ltd
I am paying by bank transfer (copy attached)
Payment by Credit Card: Visa Mastercard Amex
Credit Card PaymentsThe best way to pay by credit card is through our secure on-line registration process, simply log on to the website at www.ibc-asia.com/event/biopharma-development-production and click “Register On-line”. If you would prefer to pay over the phone please complete the contact name and details and our Customer Services Team will call within 24 hours to take payment. As we treat your credit card information in the strictest confi dence, please do not send payment details by email.
Credit card contact:: Department:
Direct phone number: Email:
(Please provide photocopy of front & back of your Credit Card)
Delegate 1 Details
Name: Dr/Mr/Ms
Job Title:
Department
Tel:
Mobile No.:
Email:
Delegate 2 Details
Name: Dr/Mr/Ms
Job Title:
Department
Tel:
Mobile No.:
Email:
Who is Head of your Department?
Who is Head of Training?
Company Name: Main Business/Activity:
Address: Postal Code:
Please quote the name of the delegate, event title and invoice number on the advice when remitting payment. Bank charges are to be deducted from participating organisations own accounts. Please fax your payment details (copy of remittance advice, cheque or draft to +65 6508 2407).
Attendance will only be permitted upon receipt of full payment. Participants wishing to register at the door are responsible to ensure all details are as published. IBC assumes no further liability or obligation, beyond the refund of the paid registration fee, in the event of postponement or cancellation by IBC.
IMPORTANT NOTE
Should you be unable to attend, a substitute delegate is welcome at no extra charge. Cancellations must be received in writing at least 10 business days before the start of the event, to receive a refund less 10% processing fee per registration. The company regrets that no refund will be made available for cancellation notifications received less than 10 business days before the event.
CANCELLATIONS / SUBSTITUTION
The personal information entered during your registration/order, or provided by you, will be held on a database and may be shared with companies in the Informa Group in the UK and internationally. Occasionally, your details may be obtained from or shared with external companies who wish to communicate with you offers related to your business activities. If you do not wish your details to be used for this purpose, please contact our Database Department at Email: [email protected], Tel: +65 6508 2400 or Fax: +65 6508 2408.
DATA PROTECTION
Marina Mandarin Singapore, by Meritus 6 Raffles Boulevard, Marina Square, Singapore 039594 Tel: (65) 6842 1243 | Fax: (65) 6845 1020E: [email protected]
HOTEL INFORMATION
Payment must be received 10 business days prior to the event. To take advantage of discounts with an expiry cut-off date, registration and payment must be received by the cut off date. All payments should be made in Singapore dollars.
Payments by S$ bank draft or cheque should be made in favour of “IBC Asia (S) Pte Ltd” and mailed to:
IBC Asia (S) Pte Ltdc/o Informa Regional Business Services103 Penang Road Visioncrest Commercial #04-01 Singapore 238467
Payment by telegraphic transfer in S$ must be made to:
IBC Asia (S) Pte LtdA/CNo.: 147-059513-001 (SGD)The Hongkong and ShanghaiBanking Corporation Limited21 Collyer Quay, HSBC Building,Singapore 049320Bank Swift Code: HSBCSGSGBank Code: 7232
Payment by Credit Card (AMEX, VISA or MASTERCARD).
Please provide your Card Number, Name of Cardholder, Expiry Date and Signature and send it by fax to +65 6508 2407.
PAYMENT TERMS
Bank Name: The Hongkong and Shanghai BankingCorporation LtdBank Address: 21 Collyer Quay HSBC BuildingSingapore 049320Bank Account Name: IBC Asia (S) Pte LtdSWIFT CODE: HSBCSGSGA/c No.: 260-457866-178 (USD)
Bank account name: 艾毕思会务服务（上海）有限公司Company Address: 上海市静安区西康路828号311室Bank Name: 汇丰银行(中国)有限公司上海分行Bank Address: 上海市静安区南京西路1376号上海商城5层504室Bank Account Number: 720-031103-001(CNY)Swift code: HSBCCNSH
Suntec, Singapore International Convention & Exhibition Centre 1 Raffles Boulevard Suntec City, Singapore 039593
VENUE INFORMATION
Yes! I/We will attend ispe singapore annual conference 2019, 21 - 23 August 2019
I cannot attend this event but please include me on your mailing list
I would only like to purchase the conference documentation at SGD1,000 / SGD1,070 (with 7% GST) per set
RESERVE YOUR PLACE TODAY!
Special Group Rates for Pharma/Manufacturing Companies Only!- Applicable only to 2-day main conference days.- The organizer reserves the right to determine the industry to which your company belongs, and to stop the promotion at any stage.
ISPE Member - Please provide ISPE membership ID during registration
FEE PER DELEGATE (SGD)
Early Birdon or before 22 June 2019
Special Rateon or before 27 July 2019
Standard Rateafter 27 July 2019
Group Rate (per person, 3 or more delegates)
SPECIAL GROUP RATES FOR PHARMA/MANUFACTURING ONLY
5 or more delegates 10 or more delegates
1 Day Pass $599 $699 $799 $599
2 Day Pass $1,199 $1,299 $1,399 $1,199 $999 $799
Non ISPE Member BECOME A MEMBER
FEE PER DELEGATE (SGD)
Early Birdon or before 22 June 2019
Special Rateon or before 27 July 2019
Standard Rateafter 27 July 2019
Group Rate 3 or more delegates
SPECIAL GROUP RATES FOR PHARMA/MANUFACTURING ONLY
5 or more delegates 10 or more delegates
1 Day Pass $899 $999 $1,099 $899
2 Day Pass $1,499 $1,599 $1,699 $1,499 $1,399 $1,199
Academic Rates (applies to full time faculty/students as well as regulatory agencies personnel; proof may be requested onsite)
1 Day Pass $399
2 Day Pass $599
Optional Pre-Conference Workshop: 21 August 2019: Commissioning & Qualification (C&Q), And New
Guide Lines (S$299)
Optional Pre-Conference Workshop: 21 August 2019: Statistics For Continued Process Verification (Cpv) (S$299)
