Agenda

09:00
OPENING REMARKS FROM ISPE SINGAPORE

Joseph Micsko, President, ISPE Singapore Affiliate

09:10
GOVERNMENT ADDRESS:
HARNESSING THE FULL POTENTIAL OF PHARMA 4.0

Melissa Guan, Head, Healthcare, Economic Development Board, Singapore

09:30
LEADERSHIP KEYNOTE ADDRESS:
DRIVING INNOVATION FOR AFFORDABILITY AND ACCESS OF MEDICINES

Alexander Zach, Head of Market Access & Policy, Biocon Biologics Limited, India

10:00
PANEL DISCUSSION:
ASIA’S ROLE IN DELIVERING AFFORDABLE QUALITY HEALTHCARE

Moderator:
Pierre Winnepenninck, ISPE Singapore Conference Chair, Singapore

Panellists:
Chai Chong Meng, Director of Manufacturing Operations, Lonza Biologics, Singapore
Alexander Zach, Head of Market Access & Policy, Biocon Biologics Limited, India
Dr. Georg Singewald, Head of Global Quality Control, VP, Roche, Switzerland
Dr. Toru J Seo, Senior Director and APAC Head, Search and Evaluation, Worldwide Business Development, Chief Business Office, Pfizer Inc., Japan

10:45
Morning Refreshments

Track A (AM): PHARMA 4.0

Chairman: Chua Wee Ming, Managing Director, HGP Asia Pte Ltd at Halfmann Goetsch Partner AG, Singapore

11:30
TRANSFORMATION OF THE PHARMA VALUE CHAIN WITH INDUSTRY 4.0

Kartik Kulbhushan, Global Head and Vice President for Operations Strategy and Transformation, Dr. Reddy’s Laboratories, India

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

12:30
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

13:00
Lunch in the Exhibition Hall

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., United Kingdom

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 integrity

Danee Zainal, Head of Manufacturing and OpEx, Alcon Singapore Manufacturing

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, Singapore

Panellists:
Dr. Toru J Seo, Senior Director and APAC Head, Search and Evaluation, Worldwide Business Development, Chief Business Office, Pfizer Inc., Japan
Kartik Kulbhushan, Global Head and Vice President for Operations Strategy and Transformation, Dr. Reddy’s Laboratories, India
James Weidner, Executive Director of Process Development, Amgen, Singapore
Dr. Xiaoping Cao, Vice President and Head of CMC and Supply Chain, Cerecin, Singapore

15:45
Afternoon Refreshments

Track A (PM): DATA INTEGRITY AND GAMP 

Chairman: Chua Wee Ming, Managing Director, HGP Asia Pte Ltd at Halfmann Goetsch Partner AG, Singapore

16:25
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 compliance

Dr. Labhu Sanghani, Director of Global Quality Assurance, Jai Research Foundation (JRF Global), India

17:05
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, Singapore

Panellists:
Dr. Labhu Sanghani, Director of Global Quality Assurance, Jai Research Foundation (JRF Global), India
Jennifer Cheung, Head of External Relations Asia Pacific & Global Compliance Business Solutions, Genentech, United States
Holger Linnertz, Head of Software Development Factory, Mettler-Toledo (S) Pte Ltd., Switzerland
Mansoor (Mani) Mohammad, Director, Quality Assurance, Data Integrity and Quality Management System, Samsung Biologics, South Korea

18:00 – 19:00
PHARMANITE NETWORKING

TRACK B1 (AM): PROJECT MANAGEMENT

Chairman: Pierre Winnepenninck, ISPE Singapore Conference Chair, Singapore

11:30
PROJECT MANAGEMENT CONTINUOUS IMPROVEMENT: LESSONS LEARNED PROCESS

Hazem Eleskandarani, Project Director, Engineering & Property Services, Johnson & Johnson, United States

12:00
GMP COMPLIANCE PROJECT – FROM THE CLIENT PROSPECTIVE

A look at how the use of project management principles; with a focus on communication management, stakeholder engagement and scope definition; turned a complicated, fast track HVAC upgrade project for a pharmaceutical packaging facility from an organization working in silos; with unclear project milestones; and an undefined communication pathway; into a cohesive project team with the tools to deliver a successful qualification of the facility and allowing for the resumption of supply chain of critical medicines for the region.

Simone Hurly, Automation Engineer, MSD, South Africa
Morgan O’Brien, Business Development Manager, No Deviation Pte Ltd, Singapore

12:30
AMGEN’S CASE STUDY: OPTIMISING PROCESS IMPROVEMENT WITHIN DESIGN SPACE CAPABILITIES

 James Weidner, Executive Director of Process Development, Amgen, Singapore

13:00
Women in Pharma Lunch Panel

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?
  • Proposal

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

15:15
PANEL DISCUSSION:
PHARMA OUTSOURCING AND PROJECT MANAGEMENT   

Moderator:
Pierre Winnepenninck, ISPE Singapore Conference Chair, Singapore

Panellists:
Hazem Eleskandarani, Project Director, Engineering & Property Services, Johnson & Johnson, United States
Simone Hurly,
Automation Engineer, MSD, South Africa
James Weidner, Executive Director of Process Development, Amgen, Singapore
Teo Szu Hui, Site Facility Lead, Novartis, Singapore
Kelly Keen, Vice President Project Management, Head of PMO, Celonic, Switzerland

15:45
Afternoon Refreshments

Track B2 (PM):
ENVIRONMENT, HEALTH AND SAFETY (EHS)

Chairman: Thomas Terranova, Managing Director, Terra Asia Consulting, Singapore

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

16:50
EFFECTIVE CONTRACTOR SAFETY MANAGEMENT

  • Critical success factors and minimum requirements required to lead safety
  • Overview of how different elements can be applied to influence perceptionof 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

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 success

Anna Koay, Director of EHSS, Amgen, Singapore

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 findings

Dean Calhoun, President/CEO, Affygility Solutions, United States

18:00 – 19:00
PHARMANITE NETWORKING

TRACK C (AM): ASEPTIC OPERATIONS

Chairman: Simone Riva, Technical Chair, ISPE Singapore Affiliate, Project Manager, Fedegari Group

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’ contamination

Farooq Mustafa Chaudhry, Associate Director, Quality Operations & Biotech, Macter International Ltd., Pakistan

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 options

G Somasundaram, Head of Technology Management, Singapore, Southeast Asia & Oceania, Merck Life Science, Singapore

12:30
DESIGNING A CONTAMINATION CONTROL STRATEGY IN AN ASEPTIC FACILITY

Benjamin Sauer, Site Technical and Portfolio Lead, AstraZeneca, Australia

13:00
Women in Pharma Lunch Panel

14:15
MOIST HEAT STERILIZATORS: FROM STERILIZATION THEORY TO NO DEVIATION DESIGN

Moist heat sterilization as technology is based on a theory, the principles of which are shortly refreshed from the industry point of view. Production of aseptic drugs is object of a detailed European legislation, the core of which is contained in Annex 1 to Eudralex Vol. 4. Rather obviously, sterilizers themselves can’t comply with pharma production rules, but their design and construction must consider all of them in order to prevent any deviation from them. This has also to be the object of a proper documentation.

Dr. Chem. Eng, Vittorio Mascherpa, Senior R&D Consultant, Fegedari Group, Italy

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

15:15
NOVEL CHARACTERIZATION METHODOLOGY AND SCALE-UP STRATEGIES FOR PRODUCTION SCALE BIO REACTORS

  • Higher cell productivity
  • Optimizing Cell Culture Processes
  • Facilitating bioreactor scale up and down

Florian Krainer, Process Engineer & Project Development, ZETA GmbH, Austria

15:35
Advances in Single Use Coriolis Flow Measurement to Address Flow Measurement Challenges in Chromatograph Applications

  • Application challenges.
  • Single Use Coriolis – explanation of the technology and flow ranges available
  • Datasets to support how we met the challenges
  • Comparison against other Single Use Flow Measurement technologies such as Clamp OnUltrasonic and Flow Cell Ultrasonic and Mag Meter.
  • Final Data set showing accuracy achieved in our labs during calibration the sensors and also in a FAT environment as well as a GMP environment during equipment qualification

Dan Malani, Chairman, Malema Group Companies, Head, Malema Life Sciences Division, Singapore

15:55
Afternoon Refreshments

TRACK C (PM):
MANUFACTURING FOR CELL AND GENE THERAPY

Chairman: Ief Leroy, Managing Partner, VILS, Belgium

16:25
CELL AND GENE THERAPY: OVERCOMING CONSTRAINTS IN SCALABILITY, SUSTAINABILITY AND COST OF GOODS

Andy Rayner, Pharma Sector Director and CTO, PM Group, United States

16:50
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 manufacturing

Dr. Steve Oh, Institute Scientist / Professor, A*STAR, Singapore

17:10
Jumpstart Cell and Gene Therapy Commercialization with Single-Use Technologies

  • Differences between CGT Bioprocessing
  • Can the currently used SUS in CGT meet the requirements for commercial production of a biotherapy?
  • Scalability
  • Supply chain security
  • Cost-effective manufacturing
  • Safety and sterility
  • Critical quality attributes
  • Path forward for the industry

Dr. Derek Pendlebury, Global OEM Sales Manager, CPC – Colder Products Company, United States

17:30
CGMP CONSIDERATIONS FOR THE DESIGN AND OPERATION OF CELL THERAPY FACILITIES

Francesca McBride, Director of Regulatory Compliance, Jacobs Engineering, United States

18:00 – 19:00
PHARMANITE NETWORKING

Track D (AM): QUALITY AND COMPLIANCE

Chairman: Dr. Georg Singewald, Head of Global Quality Control, VP, Roche, Switzerland

09:00
ENSURING QUALITY COMPLIANCE IN TECH TRANSFER

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

09:45
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 building

Dr. Sannie Chong, Head of Asia Pacific Tech Regulatory Policy – Singapore Technical Operation, Roche, Singapore

10:30
Morning Tea

11:00
MANUFACTURING AND QC LABS GMP STANDALONE SIMPLE EQUIPMENT COMPLIANCE PROCESS

Mansoor (Mani) MohammadDirector, Quality Assurance, Data Integrity and Quality Management System, Samsung Biologics, South Korea

11:40
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 / Tableau

Dr. Susanna Nagel, Quality Site Head, Roche, Singapore

12:30
Lunch

Track D (PM): QUALITY AND COMPLIANCE

Chairman: Dr. Georg Singewald, Head of Global Quality Control, VP, Roche, Singapore

13:45
SUPPLIER QUALITY MANAGEMENT IN A PHARMACEUTICAL COMPANY

  • Risk assessment application in supplier management
  • The life cycle of supplier management process
  • Common findings of supplier audits

Ting-Yuan Tan (Dennis), Manager, Quality Assurance, ASQ Certified Quality Auditor, Tanvex Biopharma Inc., Taiwan

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 QMS

Dinar Wahyuni, Quality Assurance Executive, Strides Pharma, Singapore

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 productivity

Dr. Nirmal Kumar, Head, Quality Assurance, Novugen Pharma, Malaysia

15:15
Afternoon Refreshments

15:45
DIGITAL- LET THE WATER EXPERTS MONITOR, MANAGE AND IMPROVE THE OPERATION OF YOUR COMPENDIAL WATER SYSTEMS

Ranj Rihal, Pharmaceutical and Cosmetics Business Development, Veolia Water Technologies, United Kingdom

16:15
PANEL DISCUSSION:
QUALITY, COMPLIANCE AND SUSTAINABILITY

Moderator:
Dr. Georg Singewald, Head of Global Quality Control, VP, Roche, Switzerland

Panellists:
Ting-Yuan Tan (Dennis), Manager, Quality Assurance, ASQ Certified Quality Auditor, Tanvex Biopharma Inc., Taiwan
Dinar Wahyuni, Quality Assurance Executive, Strides Pharma, Singapore
Dr. Nirmal Kumar, Head, Quality Assurance, Novugen Pharma, Malaysia
Michelle Peake, Senior General Manager, PT Kalbio Global Medika, Indonesia

17:00 – 18:00
YOUNG PROFESSIONALS (YP) NETWORKING

Track E  (AM): LEAN AND OPERATIONAL EXCELLENCE

Chairman: Benjamin Sauer, Site Technical and Portfolio Lead, AstraZeneca, Australia

09:00
APPLIED OPERATIONAL EXCELLENCE IN PHARMACEUTICAL MANUFACTURING

Rodel Sibulo, Director Pharma Project Operations – Deputy General Director, Nanogen Pharmaceutical Biotechnology Joint Stock Company, Vietnam

09:45
ROLE OF LEADERSHIP IN FOSTERING OPERATIONAL EXCELLENCE  AND CONTINUOUS IMPROVEMENT

Jose Luis Narvaez, Plant Director, United Laboratories Inc., Vietnam

10:30
Morning Tea

11:00
CASE STUDY: ACHIEVING OPERATIONAL EXCELLENCE IN PRODUCT CHANGEOVER

Paul Tan, Head of Manufacturing Excellence, Biologics, Takeda Pharmaceuticals, 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

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

12:30
Lunch

Track E  (PM): LEAN AND OPERATIONAL EXCELLENCE

Chairman: Benjamin Sauer, Site Technical and Portfolio Lead, AstraZeneca, Australia

13:45
CASE STUDY: OPERATIONAL EXCELLENCE IN PHARMA R&D

Stephen Shi, Lean Six Sigma Director, Fosun Pharma, China

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

14:45
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 data

 Akash Trivedi, Product Manager, METTLER-TOLEDO (S) PTE LTD., United States

15:15
Afternoon Refreshments

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, Executive Director, Reagent Development and Pilot Plant Operations, Charles River Laboratories, Microbial Solution, United States

16:15
PANEL DISCUSSION:
CREATING AND MANAGING AN OPERATIONAL EXCELLENCE MANAGEMENT SYSTEM

Moderator:
Benjamin Sauer, Site Technical and Portfolio Lead, AstraZeneca, Australia

Panellists:
Rodel Sibulo, Director Pharma Project Operations – Deputy General Director, Nanogen Pharmaceutical Biotechnology Joint Stock Company, Vietnam
Stephen Shi, Lean Six Sigma Director, Fosun Pharma, China
Arnel Cabungcal, Assistant Vice President – Manufacturing, United Laboratories Inc, Philippines
Harry Benson, Global Director, Human Performance Services, CAI, United States

17:00 – 18:00
YOUNG PROFESSIONALS (YP) NETWORKING

TRACK F (AM): CLEANING AND VALIDATION

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

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 testing

Christian Cater, Head of Operational Excellence, Roche, Singapore

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 analysis

Murugappan Karthick, Research Scientist, Institute of Chemical and Engineering Sciences, A*STAR, Singapore

10:00
CLEANING VALIDATION FOR PHARMACEUTICAL

  • Overview of cleaning validation protocol for cosmetic products
  • How much variation is acceptable in products and processes?
  • New techniques in designing cleaning process

Lathalu Krishnamoorthy, Quality Control and Assurance Manager, ICM Pharma, Singapore

10:30
Morning Tea

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 disinfection

Richard Chai, Technical Service Manager, STERIS Corporation, 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 connector

Raymond Dallago, Director of Sales, SaniSure, United States

12:00
PANEL DISCUSSION:

EMERGING CLEANING TECHNOLOGIES AND INNOVATIONS

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

Panellists:
Christian Cater, Head of Operational Excellence, Roche, Singapore
Murugappan Karthick, Research Scientist, Institute of Chemical and Engineering Sciences, A*STAR, Singapore
Lathalu Krishnamoorthy, Quality Control and Assurance Manager, ICM Pharma, Singapore
Richard Chai, Technical Service Manager, STERIS Corporation, Singapore

12:30
Lunch

TRACK  G (PM): TECH TRANSFER

Chairman: Liu Shan Shan, ISPE Singapore Vice President, Singapore

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 roadblocks

Wu Tai Jung, Director of Production Technology Division, GONGWIN Biopharm, Taiwan

14:15
TECH TRANSFER AND COMMERCIALIZATION OF BIOLOGICS

  • Critical steps for a successful tech transfer process
  • Risk management in the tech transfer of biologics
  • Overcoming challenges of biologics process transfer

Dr. Nils Bischoff, Customer Project Management, Vetter Pharma-Fertigung GmbH & Co. KG, Germany
Suyamburam Sathasivam, Assistant Vice President and Head of External Manufacturing Biologics, Sun Pharma, Dubai

14:45
NAVIGATING REGULATORY AND COMPLIANCE ISSUES SURROUNDING TECH TRANSFER

Dr. Harleen Kaur, Senior Research Scientist-I, Aurobindo Biologics, India

15:15
Afternoon Refreshments

15:45
BEST PRACTICES FOR EFFECTIVE TECH TRANSFER- FROM R&D TO CLINICAL TO COMMERCIAL

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

Panellists:
Wu Tai Jung, Director of Production Technology Division, GONGWIN Biopharm, Taiwan
Suyamburam Sathasivam, Assistant Vice President and Head of External Manufacturing Biologics, Sun Pharma, Dubai
Dr. Harleen Kaur, Senior Research Scientist-I, Aurobindo Biologics, India

16:30
Close of Conference

17:00 – 18:00
YOUNG PROFESSIONALS (YP) NETWORKING

Workshop 1 : 13:00 – 17:00
Hands-On Implementation of Risk-Based Qualification following the New ISPE Baseline Guide

Workshop Synopsis:
With the 2nd revision of the ISPE Baseline Guide 5 published 18 Years after the first edition, this is the first Workshop on the topic in Asia. This highly interactive workshop will summarise many years of Commissioning and Qualification guidance & practice, leading to the current regulatory expectation. Focusing on a hands-on example illustrating the latest Commissioning and Qualification best practices, you will be able to apply new concepts during the workshop. Gain the knowledge needed to lead efficient and value adding qualification activities.

Key Takeaways:

  • Understand the relationship between ICH Q9, FDA Process Validation Guide, ASTM E2500 and ISPE Guide
  • New guidance: What has changed and what has not?
  • What is a Quality Risk Assessment?
  • From QRA to URS and back
  • What is expected output of a DQ?
  • Develop an effective testing strategy
  • Identify and focus on critical aspects

Attendance Suggested for:
Anyone who wants to understand and use the Science and Risk-based approach for Commissioning and Qualification.

Project engineers, project managers, commissioning and validation professionals, engineering service providers, and quality assurance personnel involved in qualification and validation and regulatory… Anyone!

Workshop Speakers:

Pierre Winnepenninck
ISPE Singapore Conference Chair
,Singapore

With a degree in chemistry and chemical engineering, Pierre combines the scientific mindset with the practical approach of the engineer. Applying analytical skill and practical sense has proved the perfect fit for design and commissioning activities in a field that requires accuracy and productivity.

After working in several projects around Europe as consultant for one of the leading pharmaceutical company, he opened his own service company in 2007, and is currently providing services on 3 different projects in Singapore and China. He believes in People skill and manages them at their best, to optimize the available competences.

His customer is his concern, whom he advises and supports throughout all project phases, according to identified needs.

Hazem Eleskandarani
Project Director, Engineering & Property Services
Johnson & Johnson, United States

Hazem Eleskandarani holds a master degree in Mechanical Engineering from the University of Utah and is a licensed Professional Engineer.  Hazem has 30 years of diverse experience that includes manufacturing, plant engineering, process design, technology management, and project engineering.  He began his career in 1988 in the steel industry as an equipment engineer responsible for equipment PM and plant annual shutdown repairs.  In 1996, Hazem joined Fluor Daniel working on pharmaceutical projects, before moving to Jacobs Engineering pharmaceutical process equipment group.  In 2000, Hazem joined Merck Pharmaceutical Process Engineering working on several global projects in Spain, Italy, Ireland, US and Singapore.  He joined Johnsons & Johnson in 2014 as Global Director for C&Q providing global leadership for C&Q planning and execution across J&J’s global portfolio of capital projects.  In January 2019, Hazem started a new role with J &J as Project Director in the Americas Region responsible for delivering capital projects from concept to close out.  Hazem lives in Worcester, Pennsylvania.

Workshop 2: 13:00 – 17:00
Root Cause Analysis and CAPA

Workshop Synopsis:
Root Cause Analysis (RCA) continues to be a topic observed by regulators as something the biopharmaceutical industry does poorly.  The most common failings include poor investigative techniques, not reaching true root cause and ineffective CAPA.  This workshop will look at tools and techniques that are effective in conducting better root cause investigations and CAPA.  The session will include some background on the techniques, examples of their use and then a group exercise where attendees will be asked to participate in a simulated incident and investigation, putting these tools into practice.  The group exercise will be reviewed and discussed to assist to reinforce the learning and discussion

This workshop is intended to be at an intermediate level; however work groups will be formed which provide a good cross section of experience.

Key Takeaways:

  • An understanding of the common failings in RCA and CAPA under GMP
  • Details of some techniques for RCA that have been shown to be effective for the biopharmaceutical industry
  • Strategies for running an effective CAPA system
  • Worked examples for the use of RCA tools
  • Feedback and discussion on questions/issues you may have in this area.

Workshop Speaker:

spk-maurice-parlane

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

Maurice Parlane is a professional engineer with over 30 years in the pharmaceutical industry both in manufacturing and consulting roles.  He is an ISPE instructor specialising in the application of science and risk based techniques for quality management, including QbD, Process Validation, Technology Transfer, Quality Risk Assessment and CAPA.

Women in Pharma Brainstorming Lunch & Talk

  • All are welcome! Entry with a Women in Pharma pin (available at ISPE, CAI & No deviation booths; donations of US$ 10 / US$ 15 and above; all proceeds go to ISPE Foundation)
  • Engage in lively discussion and insights with facilitators drawn from industry leaders.

1st time! Happy Hour & Young Professionals (YP) Networking

23 August 2019, 5.30pm 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!

NEW! ISPE Singapore Hackathon – calling Students & Young Professionals*!

21 – 22 August 2019 9am-7pm

*Students may be Undergraduates or Post-graduate; Young Professionals (YPs) are members with up to 5 years’ industry experience.

Singapore and regional affiliates have held Poster Competitions for individual entrants, with the overall winner sponsored to present their poster at the USA Annual meeting. Last year, our regional winner from Philippines, Cy M. Rodriguez took the global award in the Undergraduate category!

This year, ISPE Singapore is proud to host the first Hackathon, for students and young professionals (YPs)!

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.

Teams compete for a Team Prize, while the Best Performer Prize will be awarded to an individual, to participate in the Hackathon at the USA Annual meeting in Las Vegas. This takes place from 26-27 October and culminates with the Annual Member Brunch and Award Ceremony on 29 October 2019.

FAQs:

  • Eligibility Criteria
    • Young Professional with 1 – 5 years experience in the life sciences industry
    • Undergraduate student with internship/work experience in the life sciences industry
    • All participants must be current or sign up as ISPE members by 21st August 2019
  • The overall Best Performer must be available to join the Annual Meeting Hackathon in Las Vegas from 25-29 October 2019. If not, the next runner-up will be granted travel and accommodation to compete.
  • The Team Prize will be awarded and shared amongst the winning team.
  • Individuals will be assigned to a team, comprising a mix of students and YPs