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Opening Remarks
Emily Cheah
  • Emily Cheah (Managing Director of Charles River Laboratories (Singapore))

    Emily Cheah

    Managing Director of Charles River Laboratories (Singapore)

    A pharmacist by training, Emily is currently Senior Managing Director of Charles River Laboratories Singapore (Microbial Solutions) and APAC Technical Operations Lead. Emily oversees the APAC laboratory operations, as well as site operations including R&D / Centre of Excellence, and market development operations. She is oversees technical programme roll outs in APAC and is involved in the evaluation and implementation of new technology & services within the Microbial Solutions division and serves on various committees within the company.

    She received her Ph.D. (Pharm. Technology) from the National University of Singapore and her EMBA from INSEAD.

    Emily is one of the founding members of the PDA Singapore Chapter and has served as a Board Member in various capacities since its inception in 2013.

    Emily is the current President of PDA Singapore Chapter.

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Overview of Singapore’s Biopharmaceutical Ecosystem
Chee How Lee

As a hub of choice at the heart of Asia, Singapore has seen biopharmaceutical companies set up and grow their manufacturing, R&D and commercial activities here to serve patients in the growing Asian market as well as across the world. This presentation will provide an overview of Singapore’s biopharmaceutical industry and highlight the ways in which are future-proofing the local ecosystem, with a focus on talent development, innovation, supplier diversification, sustainability and provision of flexible infrastructure options.

  • Chee How Lee (Assistant Vice President at Economic Development Board)

    Chee How Lee

    Assistant Vice President at Economic Development Board
Coffee Break
Regulatory Updates IIntroduction by the Moderator
Dinesh Khokal
  • Dinesh Khokal (Director and Regional Lead, External Affairs, JAPAC of Amgen Biotechnology Singapore)

    Dinesh Khokal

    Director and Regional Lead, External Affairs, JAPAC of Amgen Biotechnology Singapore

    Dinesh. as a Director and Regional Lead of External Affairs in Amgen, is currently responsible for shaping external regulatory and GXP landscape in collaboration with industry peers and regulators in Japan Asia Pacific. Additionally, Dinesh holds the position of Adjunct Associate Professor at the Faculty of Health and Medical Sciences, Taylor’s University, Malaysia.

    He is an accomplished pharmaceutical professional with distinguished career of over 35 years of combined experience in regulatory agency, biopharmaceutical & diagnostic industries, and academia.

    Prior to Amgen, Dinesh held the role of Director of Therapeutic Products Branch at the Singapore Health Sciences Authority (HSA). During his tenure in HSA, Dinesh held many different roles including Senior GMP Inspector. He has also played several key roles in multiagency consortiums and World Health Organization initiatives working towards capability building, shaping regulatory landscape, regulatory harmonisation, and mutual reliance.

    Dinesh received his Ph.D. in Cell and Molecular Biology from the National University of Singapore. Dinesh he is currently on the PDA Regulatory Affairs and Quality Advisory Board (RAQAB). He is a recipient of 2020 PDA Distinguished Service Award.

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Contamination Control Risk Management and Quality Culture
Wallace Torres

Risk management and the link to robust Quality Controls has been a topic for the last years. In this presentation, we will talk about the importance of a robust Risk Control strategy and how this strategy is translated into the key areas of Quality controls. In addition, we will be presenting a “sneak peek” of the draft Contamination Control PDA technical report to be published soon.

  • Wallace Torres (VP Site Operations at Amgen Singapore Manufacturing)

    Wallace Torres

    VP Site Operations at Amgen Singapore Manufacturing
ICHQ9 Quality Risk Management
Rick Friedman
  • Rick Friedman (Deputy Director, Office of Manufacturing Quality at US FDA)

    Rick Friedman

    Deputy Director, Office of Manufacturing Quality at US FDA

    Richard L. Friedman is Deputy Director, Office of Manufacturing Quality, which is part of the compliance office in FDA's Center for Drug Evaluation and Research (CDER). This position includes oversight of regulatory action recommendations relating to inspections and manufacturing site acceptability, and promoting sound regulatory policy development. Mr. Friedman has authored several publications on topics including sterile drugs and quality systems. Mr. Friedman has been a faculty member in Temple University School of Pharmacy’s QA/RA graduate program since 2003. Prior to joining FDA in 1990, Mr. Friedman worked in the toxicology research division of Parke-Davis. Mr. Friedman received his B.S. in Biology with honors from Montclair State University in 1989, and his M.S. in Microbiology from Georgetown University School of Medicine in May, 2001.

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Data Governance: Are We (Really) Inspection Ready?
Peter Baker

Are you struggling to understand the introduction of Data Governance in the context of the CGMP? We see Data Governance heavily emphasized in the PIC/s guide for data integrity and are therefore expected to demonstrate adoption of the concept during regulatory inspection, however, presenting a functioning governance program during inspection can be tricky or even confusing without practice. In this talk we will discuss Data Governance in the context of our existing Data Integrity initiatives, and how a few simple self-evaluation initiatives can determine if we are ready to practice, explain and defend our Data Governance strategy during inspection.

  • Peter Baker (President at Live Oak Quality Assurance LLC)

    Peter Baker

    President at Live Oak Quality Assurance LLC
Panel Discussion and Q&A
Peter BakerRick FriedmanDinesh KhokalWallace Torres
  • Peter Baker (President at Live Oak Quality Assurance LLC)

    Peter Baker

    President at Live Oak Quality Assurance LLC
  • Rick Friedman (Deputy Director, Office of Manufacturing Quality at US FDA)

    Rick Friedman

    Deputy Director, Office of Manufacturing Quality at US FDA
  • Dinesh Khokal (Director and Regional Lead, External Affairs, JAPAC of Amgen Biotechnology Singapore)

    Dinesh Khokal

    Director and Regional Lead, External Affairs, JAPAC of Amgen Biotechnology Singapore
  • Wallace Torres (VP Site Operations at Amgen Singapore Manufacturing)

    Wallace Torres

    VP Site Operations at Amgen Singapore Manufacturing
Delivering Value With a Digital QMS (Product Demo by Sparta Systems, a Honeywell Company
Santhosh Francis
  • Santhosh Francis (Area Vice President, South Asia and ANZ at Sparta Systems, a Honeywell Company)

    Santhosh Francis

    Area Vice President, South Asia and ANZ at Sparta Systems, a Honeywell Company

    Santhosh is an achievement-driven professional having 29 years of experience cross functional experience in diverse functions. For the past 16 years he has been actively involved in the life-sciences industry in South Asia and ANZ working closely with partners, customers and government organizations to understand and meet their requirements in health information exchange, pharmacovigilance, quality, document and training management solutions, customer experience, product life cycle management, performance management, clinical R&D data management and clinical trial management.

    In his current role at Sparta, he supports multiple organisations embracing change with an emphasis in quality and delivering large-scale business transformation. Prior to joining Sparta Systems, Santhosh worked with leading organizations such as Oracle, IBM and Sonata Software mostly in IT Infra, Cloud/SaaS and especially in SW tools and applications.

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Improved CMC Biosafety Testing Strategies In-line with ICH Q5A(R2) (Product Demo by Merck)
Edmund Ang
  • Edmund Ang (Senior Technical Expert, Asia Pacific, BioReliance® Biosafety Testing Services, at Merck Group)

    Edmund Ang

    Senior Technical Expert, Asia Pacific, BioReliance® Biosafety Testing Services, at Merck Group

    Dr. Edmund Ang, a Senior Technical Expert and joined Merck’s BioReliance Biosafety Testing in 2017. Dr. Ang provides technical support on CMC testing of biotherapeutics to biopharma developers and manufacturers in Asia Pacific. He has more than 20 years of experience in life science industry with R&D experience in cancer drug and biomarker discovery at Eli Lily and Ionis Pharmaceuticals, as well as commercial technical experience in cellular analysis and bioproduction with Roche Diagnostics, Life Technologies/Thermo Fisher Scientific.

    Dr. Ang obtained his Ph.D. in Cell Biology from the University of Edinburgh and conducted his postdoctoral research on cell signalling at Stanford University and National Cancer Centre, Singapore.

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Lunch Break
Regulatory Updates IIIntroduction by the Moderator
Rama Tummala
  • Rama Tummala (Q&C Audit Manager, Global Quality Audit & Compliance at GSK)

    Rama Tummala

    Q&C Audit Manager, Global Quality Audit & Compliance at GSK

    A Master of Science (Pharmaceutical Operations) graduate, Rama is currently working with GSK as a Q&C Audit Manager in Global Quality Audit & Compliance division. His experience in Pharmaceutical industry over 30 years covers Sterile, Non-sterile, Biopharm and Consumer segments in the areas of Q&C Audits, Validations, QA, Technology Transfer, Manufacturing Operations and Greenfield Project Management. He has previously worked in India with CIPLA, The Himalaya Drug Co., Alcon Labs (Novartis group); in the USA and Singapore with Alcon Labs.

    He served as a PDA Singapore Chapter Member at Large in the

    previous term.

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PIC/S – EMA WG Annex 1 Update
Matthew Davis

Presentation providing an update on the Annex 1 update process, delivered by PIC/S Annex 1 Working Group representative. This presentation will outline the key steps taken, feedback received during consultation phases, progress to date, areas of focus. Matt will provide technical information relevant to the anticipated changes that will be included in the final document upon adoption.

  • Matthew Davis (Inspections Team Lead - Senior Inspector, Manufacturing Quality Branch at Therapeutic Goods Administration (TGA) - Australian Government)

    Matthew Davis

    Inspections Team Lead - Senior Inspector, Manufacturing Quality Branch at Therapeutic Goods Administration (TGA) - Australian Government
Panel Discussion and Q&A
Meow Hoe BoonMatthew DavisRama TummalaDinesh Khokal
  • Meow Hoe Boon (Deputy Director cum Senior GMP Auditor, Audit & Licensing Division of Health and Sciences Authority)

    Meow Hoe Boon

    Deputy Director cum Senior GMP Auditor, Audit & Licensing Division of Health and Sciences Authority
  • Matthew Davis (Inspections Team Lead - Senior Inspector, Manufacturing Quality Branch at Therapeutic Goods Administration (TGA) - Australian Government)

    Matthew Davis

    Inspections Team Lead - Senior Inspector, Manufacturing Quality Branch at Therapeutic Goods Administration (TGA) - Australian Government
  • Rama Tummala (Q&C Audit Manager, Global Quality Audit & Compliance at GSK)

    Rama Tummala

    Q&C Audit Manager, Global Quality Audit & Compliance at GSK
  • Dinesh Khokal (Director and Regional Lead, External Affairs, JAPAC of Amgen Biotechnology Singapore)

    Dinesh Khokal

    Director and Regional Lead, External Affairs, JAPAC of Amgen Biotechnology Singapore
Regulatory Updates IIIIntroduction by the Moderator
Li Wei Chan
  • Li Wei Chan (Microbiology Manager at MSD International GmbH (Singapore Branch))

    Li Wei Chan

    Microbiology Manager at MSD International GmbH (Singapore Branch)

    Li Wei joined MSD International GmbH (Singapore) Biotech Sterile Fill- Finish site as the Microbiology Manager since Nov 2020. In this role, Li Wei is responsible for managing the EM program for aseptic cleanrooms & critical utilities, contamination control strategy for sterile final drug products and qualifications for new product introduction. He also ensures compliance to corporate and regulatory standards and supported regulatory inspections e.g. FDA PAI for Keytruda. In his previous roles, Li Wei was responsible for developing microbial control strategies, developing microbiological test methods, managing laboratory compliance and managed internal quality audits.



    Li Wei received his Bachelor of Science (Biotechnology) from Monash University, certified Quality Auditor and had 16 years of experience in the pharmaceutical and medical devices industry (sterile & non-sterile manufacturing facilities).

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Implementation of ICHQ5A Recommendations for Biosafety of Medicinal Products: What's New
Dr. Alison Armstrong

Recent advancements in bioprocessing have supported the accelerated growth of the biopharmaceutical industry. The ability to use alternate technologies to mitigate viral risk has been central to the expedited regulatory approval for biotechnological products. With the advent of an update to the ICHQ5A(R2) regulation, although the overarching strategy of risk mitigation has not been modified, this regulation now encompasses increased recommendation for a wider selection of medicinal products and brings to the fore current scientific and industry approaches for viral clearance, continuous biomanufacturing and updated technologies to support biosafety testing. The use of molecular technologies which are shown to be comparable to classical methods have been at the forefront of such technology advances. As many of the current cell substrate and viral safety guidance provide flexibility to use alternative approaches with broad virus detection capabilities which are deemed “fit-for-purpose”. This presentation will provide supporting data for the updated recommendations in ICHQ5A(R2) and will provide practical applications as an orthogonal approach to viral pathogen risk mitigation that continues to meet regulatory expectations

  • Dr. Alison Armstrong (Senior Director and Global Head of the Technical and Scientific Solutions at Merck)

    Dr. Alison Armstrong

    Senior Director and Global Head of the Technical and Scientific Solutions at Merck
ECA Guidelines on CCS with Case Studies
Walid El Azab

The presentation explains the implementation of a CCS across a facility. The presentation shares a guideline and a template to deploy a successful CCS. A comparison of the ECA CCS template with other CCS examples will be presented as a case study on how a CCS could be documented. Then, a discussion around the future challenges a manufacturer may encounter with a holistic approach and how novel technology and data science combined with statistics may overcome the future challenges.

  • Walid El Azab (Senior Manager Technical Services at STERIS)

    Walid El Azab

    Senior Manager Technical Services at STERIS
Risk Assessment in Facility Design for Microbiological Control in Cell and Gene Therapy Manufacturing
Michelle PeakeJo Sherriff

Biologic facility projects are not only technically complex but also complicated due to the interfaces with the many parties involved in the process. It is important to ensure a process risk assessment (PRA) is developed early in the project with all relevant stakeholder’s involvement, whether for green-field or brown-field construction, or even for existing facilities wanting to transition to GMP operations.

The PRA will provide the necessary information to implement the project and to accurately specify the design to ensure microbial control via conducting appropriate facility qualification and process validation activities. The complexities of contamination control of cell & gene therapy facilities together with the requirements for sterile/aseptic manufacture should not be underestimated during the facility design.

This presentation will draw on the speakers’ real-life experiences and case studies, and risks that have been mitigated early on in the design phase to ensure microbial control.

  • Michelle Peake (Senior Consultant, Quality/Biopharma at SeerPharma Pty Ltd)

    Michelle Peake

    Senior Consultant, Quality/Biopharma at SeerPharma Pty Ltd
  • Jo Sherriff (Senior Consultant at Seerpharma)

    Jo Sherriff

    Senior Consultant at Seerpharma
Panel Discussion and Q&A
Dr. Alison ArmstrongLi Wei ChanWalid El AzabMichelle PeakeJo SherriffEdmund Ang
  • Dr. Alison Armstrong (Senior Director and Global Head of the Technical and Scientific Solutions at Merck)

    Dr. Alison Armstrong

    Senior Director and Global Head of the Technical and Scientific Solutions at Merck
  • Li Wei Chan (Microbiology Manager at MSD International GmbH (Singapore Branch))

    Li Wei Chan

    Microbiology Manager at MSD International GmbH (Singapore Branch)
  • Walid El Azab (Senior Manager Technical Services at STERIS)

    Walid El Azab

    Senior Manager Technical Services at STERIS
  • Michelle Peake (Senior Consultant, Quality/Biopharma at SeerPharma Pty Ltd)

    Michelle Peake

    Senior Consultant, Quality/Biopharma at SeerPharma Pty Ltd
  • Jo Sherriff (Senior Consultant at Seerpharma)

    Jo Sherriff

    Senior Consultant at Seerpharma
  • Edmund Ang (Senior Technical Expert, Asia Pacific, BioReliance® Biosafety Testing Services, at Merck Group)

    Edmund Ang

    Senior Technical Expert, Asia Pacific, BioReliance® Biosafety Testing Services, at Merck Group
Coffee Break
Digitalization and Advancements: Introduction by the Moderator
Andiyanto Sutandar
  • Andiyanto Sutandar (Manager at NNIT Singapore)

    Andiyanto Sutandar

    Manager at NNIT Singapore

    Andiyanto is a Manager in NNIT Singapore. Andi leads NNIT Singapore's Manufacturing Science and Technology service unit. He has broad and in-depth experience in technology transfer, NPI, risk management, deviation and NC management, supply chain management, manufacturing workflow optimization and project management in the pharmaceutical industry. Additionally, Andi has expertise in infection control risk management and design & management of high containment facilities for infectious diseases research.

    Andi has been a volunteer with PDA Singapore Chapter since 2015 and has previously served as Secretary of PDA Singapore Chapter board. He holds a PhD in Mechanical & Production Engineering from Nanyang Technological University.

    Andi is the current President-Elect of PDA Singapore Chapter.

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Deriving Strategic Value from a GMP Compliant Paperless Quality System
Santhosh Francis

Pharmaceutical manufacturing quality data and processes have always required a high level of validation and oversight to ensure GMP compliance. However, while the continued use of manual, fragmented, or paper-based systems can only increase the risk of data variance and regulatory errors, the impact on operational efficiency, product quality, and supply chain continuity can actually be even more impactful on an organisation and their patients.


During this session, attendees will gain insights into:
· Why an evolution away from paperless systems is now a quality manufacturing imperative
· How quality management can directly impact manufacturing KPIs and business outcomes
· How digital innovation has simplified the transition to an agile and effective paperless QMS

  • Santhosh Francis (Area Vice President, South Asia and ANZ at Sparta Systems, a Honeywell Company)

    Santhosh Francis

    Area Vice President, South Asia and ANZ at Sparta Systems, a Honeywell Company
Data Integrity Enhancements vs Challenges
Robert Lutskus

The talk will discuss the challenges associated with the continued focus on data integrity. We will explore the challenges from various angles. These will include ensuring the vendor has the right tools available in the software, the end user following the required rules without adding additional work, and the teams responsible for ensuring the compliance by looking at some best practices in the data review.

  • Robert Lutskus (Director, Informatics Operations, of Lonza)

    Robert Lutskus

    Director, Informatics Operations, of Lonza
Panel Discussion and Q&A
Robert LutskusAndiyanto SutandarSanthosh Francis
  • Robert Lutskus (Director, Informatics Operations, of Lonza)

    Robert Lutskus

    Director, Informatics Operations, of Lonza

    Rob Lutskus is a subject matter expert on GxP informatics solutions with over 20 years’ experience in the bio-pharmaceutical industry. Currently, Director, Informatics Operations for Lonza Bioscience, Rob is responsible for leading all technical sales support, customer service, development, testing, validation and professional delivery activities for Lonza's Informatics software portfolio. He also develops the product strategy and roadmap for software releases. The portfolio he manages, started with environmental monitoring software, MODA-EM™ and has expanded to laboratory software, WinKQCL™ and manufacturing and electronic log software, MODA-ES™


    Rob is an active member in a variety of industry organizations, including the Parenteral Drug Association and ISPE. He is also a contributing author to Environmental Monitoring: A Comprehensive Handbook, Volume 3.

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  • Andiyanto Sutandar (Manager at NNIT Singapore)

    Andiyanto Sutandar

    Manager at NNIT Singapore

    Andiyanto is a Manager in NNIT Singapore. Andi leads NNIT Singapore's Manufacturing Science and Technology service unit. He has broad and in-depth experience in technology transfer, NPI, risk management, deviation and NC management, supply chain management, manufacturing workflow optimization and project management in the pharmaceutical industry. Additionally, Andi has expertise in infection control risk management and design & management of high containment facilities for infectious diseases research.

    Andi has been a volunteer with PDA Singapore Chapter since 2015 and has previously served as Secretary of PDA Singapore Chapter board. He holds a PhD in Mechanical & Production Engineering from Nanyang Technological University.

    Andi is the current President-Elect of PDA Singapore Chapter.

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  • Santhosh Francis (Area Vice President, South Asia and ANZ at Sparta Systems, a Honeywell Company)

    Santhosh Francis

    Area Vice President, South Asia and ANZ at Sparta Systems, a Honeywell Company

    Santhosh is an achievement-driven professional having 29 years of experience cross functional experience in diverse functions. For the past 16 years he has been actively involved in the life-sciences industry in South Asia and ANZ working closely with partners, customers and government organizations to understand and meet their requirements in health information exchange, pharmacovigilance, quality, document and training management solutions, customer experience, product life cycle management, performance management, clinical R&D data management and clinical trial management.

    In his current role at Sparta, he supports multiple organisations embracing change with an emphasis in quality and delivering large-scale business transformation. Prior to joining Sparta Systems, Santhosh worked with leading organizations such as Oracle, IBM and Sonata Software mostly in IT Infra, Cloud/SaaS and especially in SW tools and applications.

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Contamination Control and Microbiology Session (Part I)Moderator Introduction
Richard Chai
  • Richard Chai (Technical Service Manager, Life Sciences at STERIS Corporation)

    Richard Chai

    Technical Service Manager, Life Sciences at STERIS Corporation

    Richard Chai is a Technical Service Manager in the Life Sciences Division of STERIS Corporation. He currently provides global technical support related to process equipment cleaning and contamination control in cleanrooms. Richard has more than 20 years of industry experience in manufacturing, validation and technical support. He has published several articles in contamination control and is a frequent speaker at industry events.

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Creating a Microbiology Investigation Playbook
Marc Glogovsky

Microbiologists are no longer hired to simply perform QC analyses as part of their routine daily work. When something inevitably goes wrong, it is up to your microbiologists to leave the lab and scour the facility, processes, and personnel to try and piece together potential source(s) of contamination. This presentation will cover some of the major points found in the recently published Technical Report #88 to help these investigatory microbiologists build a better strategy when hunting down elusive root causes!

  • Marc Glogovsky (Business Unit Manager, Microbiology Consulting at ValSource, Inc.)

    Marc Glogovsky

    Business Unit Manager, Microbiology Consulting at ValSource, Inc.
FDA Guidance on Non-Sterile Pharmaceuticals
Ziva Abraham

The USFDA draft guidance for quality considerations intended to assist manufacturers in assuring the control of microbiological quality of their non-sterile drugs (NSDs) provides clarity on contamination control measures required to prevent objectionable microorganisms in the product that can be harmful to the patient. This presentation will discuss the key takeaways from the guidance along with the challenges in deciding what organisms could be objectionable in non-sterile products via the mode of administration. As there is no comprehensive list of objectionable organisms for each type of product, this presentation will outline the various attributes of the organisms recovered during product testing that should be considered to determine objectionability.

  • Ziva Abraham (CEO of Microrite)

    Ziva Abraham

    CEO of Microrite
Coffee Break
Contamination Control and Microbiology Session (Part II): Introduction by the Moderator
Emily Cheah
  • Emily Cheah (Managing Director of Charles River Laboratories (Singapore))

    Emily Cheah

    Managing Director of Charles River Laboratories (Singapore)

    A pharmacist by training, Emily is currently Senior Managing Director of Charles River Laboratories Singapore (Microbial Solutions) and APAC Technical Operations Lead. Emily oversees the APAC laboratory operations, as well as site operations including R&D / Centre of Excellence, and market development operations. She is oversees technical programme roll outs in APAC and is involved in the evaluation and implementation of new technology & services within the Microbial Solutions division and serves on various committees within the company.

    She received her Ph.D. (Pharm. Technology) from the National University of Singapore and her EMBA from INSEAD.

    Emily is one of the founding members of the PDA Singapore Chapter and has served as a Board Member in various capacities since its inception in 2013.

    Emily is the current President of PDA Singapore Chapter.

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Fundamentals of an EM Program
Marc Glogovsky

This presentation focuses on the pending changes in Annex 1 as they relate to environmental monitoring as part of a firm’s overall contamination control strategy. There is increased emphasis on utilization of risk assessments and QRM principles for environmental and personnel monitoring. The revised Annex 1 provides details about establishing routine trending of EM data as well as appropriately set alert levels and action limits. A detailed risk-based EM program should provide comprehensive feedback regarding the efficacy of a firms’ contamination control program.

  • Marc Glogovsky (Business Unit Manager, Microbiology Consulting at ValSource, Inc.)

    Marc Glogovsky

    Business Unit Manager, Microbiology Consulting at ValSource, Inc.
Case Study: Expediting Mold Investigations with Biofluorescent Particle Counting (BFPC) Technology
Dawn WatsonLi Wei Chan

Environmental monitoring investigations often require an extended amount of time to resolve due to the length of time needed for incubation periods of media based environmental samples. In addition, it is often difficult to determine a definitive root cause. In a specific case study, an increased recovery of mold occurred requiring immediate response. Traditional methods were applied requiring long incubation periods and the team faced challenges in identifying root cause. Application of the Biofluorescent Particle Counting (BFPC) technology facilitated rapid identification of potential sources of contamination and ultimately remediation. An effectiveness check was performed in real time with the BFPC technology to ensure successful mitigation. Comparability of the BFPC technology was confirmed through parallel use of traditional methods. Based on this case study, application of the BPFC technology expedites the investigative process for EM excursions, which is essential to limit impact to not only supply, but also our customers.

  • Dawn Watson (Director, Microbial Control & Sterile COE of Merck & Co., Inc.)

    Dawn Watson

    Director, Microbial Control & Sterile COE of Merck & Co., Inc.
  • Li Wei Chan (Microbiology Manager at MSD International GmbH (Singapore Branch))

    Li Wei Chan

    Microbiology Manager at MSD International GmbH (Singapore Branch)
Implementing the QC Lab of the Future – Automating Endotoxin Testing for Water Samples
Pao Chun Lin

As one of the world’s largest vaccines company, GSK unites Science, Technology and Talent to get ahead of disease together, and develops transformational vaccines and medicine that makes life better for millions of people around the world. Quality is at the heart of everything we do. Through the introduction of automation technologies in the Quality Control Unit, we aim to achieve raw data acquisition with high efficiencies, streamline processes and minimize human errors.

As part of the plan for global site harmonization, my colleague previously shared about the ‘Evaluation and Implementation Process of Automation in GSK Vaccine QC department for our Endotoxin Testing’ in the PDA_USA conference. In this presentation, we will focus on the implementation process of the automated technology in the manufacturing site in Asia – Singapore.

Key Points discussed in this session:
-Why this technology is chosen
-Automated system interfaced with LIMS
-Qualification process

  • Pao Chun Lin (Senior QC Specialist at GSK)

    Pao Chun Lin

    Senior QC Specialist at GSK
Panel Discussion and Q&A
Ziva AbrahamRichard ChaiLi Wei ChanEmily CheahWalid El AzabMarc GlogovskyPao Chun LinDawn Watson
  • Ziva Abraham (CEO of Microrite)

    Ziva Abraham

    CEO of Microrite
  • Richard Chai (Technical Service Manager, Life Sciences at STERIS Corporation)

    Richard Chai

    Technical Service Manager, Life Sciences at STERIS Corporation
  • Li Wei Chan (Microbiology Manager at MSD International GmbH (Singapore Branch))

    Li Wei Chan

    Microbiology Manager at MSD International GmbH (Singapore Branch)
  • Emily Cheah (Managing Director of Charles River Laboratories (Singapore))

    Emily Cheah

    Managing Director of Charles River Laboratories (Singapore)
  • Walid El Azab (Senior Manager Technical Services at STERIS)

    Walid El Azab

    Senior Manager Technical Services at STERIS
  • Marc Glogovsky (Business Unit Manager, Microbiology Consulting at ValSource, Inc.)

    Marc Glogovsky

    Business Unit Manager, Microbiology Consulting at ValSource, Inc.
  • Pao Chun Lin (Senior QC Specialist at GSK)

    Pao Chun Lin

    Senior QC Specialist at GSK
  • Dawn Watson (Director, Microbial Control & Sterile COE of Merck & Co., Inc.)

    Dawn Watson

    Director, Microbial Control & Sterile COE of Merck & Co., Inc.
How to Run the Celsis® ATP-based Bioluminescence Assay for Standard & Cell Based Samples (Product Demo by Charles River Laboratories)
Yong Jian Lee
  • Yong Jian Lee (Lead Scientist at Charles River Laboratories (Singapore))

    Yong Jian Lee

    Lead Scientist at Charles River Laboratories (Singapore)

    Dr Lee Yong Jian is a Lead Scientist at Charles River Laboratories and oversees the Celsis® studies performed in Singapore. He has helped various customers demonstrate suitability of their pharmaceutical products using the Celsis® RMM technology and have conducted trainings on the Celsis® technology to internal and external customers. He is also involved in the product development and validation of new reagents and test methods for the Celsis® system. Yong Jian received his PhD degree in Environmental Microbiology and Bachelor’s degree in Life Sciences from the National University of Singapore.

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Lunch Break
ATMP Session: Introduction by the Moderator
Michelle Peake
  • Michelle Peake (Senior Consultant, Quality/Biopharma at SeerPharma Pty Ltd)

    Michelle Peake

    Senior Consultant, Quality/Biopharma at SeerPharma Pty Ltd

    Michelle has over 25 years biopharmaceutical experience specializing in Quality Assurance, Quality Control, Process Development and Production. She has hands-on experience with cell culture and fermentation, cell harvest, downstream purification/concentration and fill/finish activities with microbial, insect and mammalian cells and viruses. Michelle’s operational experience includes the design and construction of a GMP compliant biologics manufacturing facility in Penang, Malaysia and also obtaining GMP accreditation for a facility in the UK. Most recently in Indonesia she led a successful QP EMA audit. As a Senior Consultant at SeerPharma main area is GMP compliance from the initial design of a facility through to process validation activities.

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Microbiological Risk Assessments in Cell & Gene Therapy
David Keen

The world of Cell and Gene Therapy has some significant differences to traditional sterile manufacturing. It also has many similarities, one of which is the ever-present risk of microbiological contamination.

How can you keep your products sterile when they can’t be sterilised? How do you manufacture products in a way to keep the bugs from the environment out of it? This presentation will cover aspects of containment, control and the contamination threat from people and their actions. There will be a little bit of microbiology thrown in too for good measure.

  • David Keen (Director, Pharmaceutical Microbiology & Consulting of Ecolab Life Sciences)

    David Keen

    Director, Pharmaceutical Microbiology & Consulting of Ecolab Life Sciences
USP Progresses New Chapters for Microbiological Control of Cell Therapies
Donald Singer

Aligning with public interest in cell therapies and their safety, USP is progressing towards industry review of a new informational chapter about microbiological control in cell therapy manufacturing and chapters for microbiological contamination quality control tests of short shelf-life products. This presentation will share insights for the development of these valuable new chapters and key aspects that are the foundation of aseptic processing and testing of cell and gene therapies.

  • Donald Singer (Senior Microbiology Technical Consultant, North America at Ecolab Life Sciences)

    Donald Singer

    Senior Microbiology Technical Consultant, North America at Ecolab Life Sciences
Panel Discussion and Q&A
David KeenMichelle PeakeDonald Singer
  • David Keen (Director, Pharmaceutical Microbiology & Consulting of Ecolab Life Sciences)

    David Keen

    Director, Pharmaceutical Microbiology & Consulting of Ecolab Life Sciences

    David is a pharmaceutical microbiologist who has worked across the pharmaceutical industry including in primary and secondary manufacturing for over 20 years.

    He works with teams to solve complex microbiological issues such as non-sterile contamination events, sterility test failures, media trial failures, Biofilm, and product contamination events. He works with technology ranging from high spec closed system isolators utilizing robotic technology to open cleanroom manufacturing in high-risk fields such as ‘specials’ (compounding).

    In his current role David works with customers on devising the most efficient and robust contamination control strategy. He also works with customers on their environmental monitoring programs, isolators, water systems and regulatory compliance.

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  • Michelle Peake (Senior Consultant, Quality/Biopharma at SeerPharma Pty Ltd)

    Michelle Peake

    Senior Consultant, Quality/Biopharma at SeerPharma Pty Ltd

    Michelle has over 25 years biopharmaceutical experience specializing in Quality Assurance, Quality Control, Process Development and Production. She has hands-on experience with cell culture and fermentation, cell harvest, downstream purification/concentration and fill/finish activities with microbial, insect and mammalian cells and viruses. Michelle’s operational experience includes the design and construction of a GMP compliant biologics manufacturing facility in Penang, Malaysia and also obtaining GMP accreditation for a facility in the UK. Most recently in Indonesia she led a successful QP EMA audit. As a Senior Consultant at SeerPharma main area is GMP compliance from the initial design of a facility through to process validation activities.

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  • Donald Singer (Senior Microbiology Technical Consultant, North America at Ecolab Life Sciences)

    Donald Singer

    Senior Microbiology Technical Consultant, North America at Ecolab Life Sciences

    Don Singer is Senior Microbiology Technical Consultant, North America, for Ecolab, and a Fellow in the American Society for Quality. He was formerly a GSK Senior Fellow. Don was Chair of the USP Microbiology Committee of Experts and has been a member since 2000. Don is also a member of the European Pharmacopeia Group 1 Microbiology Committee. He was chair of the PDA Task Force for the TR 86, “Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing”, and was co-author of the TR 67, “Exclusion of Objectionable Microorganisms”, and is a co-author of the PDA TR for “Contamination Control Strategy”. He is a Certified Pharmaceutical GMP Professional (ASQ) and Certified Specialist Microbiologist (NRCM), and a former Malcolm Baldrige National Quality Award Examiner. Don’s career spans over 45 years of research, quality control, quality assurance experience in the pharmaceutical, biopharmaceutical, personal care, cosmetic, and food industries. Currently Don is an adjunct instructor in the Biopharmaceutical Quality graduate program at University of Maryland Baltimore County.

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Coffee Break
Contamination Control / Sterile Processing Session: Introduction by the Moderator
Rama Tummala
  • Rama Tummala (Q&C Audit Manager, Global Quality Audit & Compliance at GSK)

    Rama Tummala

    Q&C Audit Manager, Global Quality Audit & Compliance at GSK

    A Master of Science (Pharmaceutical Operations) graduate, Rama is currently working with GSK as a Q&C Audit Manager in Global Quality Audit & Compliance division. His experience in Pharmaceutical industry over 30 years covers Sterile, Non-sterile, Biopharm and Consumer segments in the areas of Q&C Audits, Validations, QA, Technology Transfer, Manufacturing Operations and Greenfield Project Management. He has previously worked in India with CIPLA, The Himalaya Drug Co., Alcon Labs (Novartis group); in the USA and Singapore with Alcon Labs.

    He served as a PDA Singapore Chapter Member at Large in the

    previous term.

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Contamination Control Strategy (CCS) in Sterile Fill-Finish Facility
Li Wei Chan

With the expectations of CCS in Annex 1, how could a sterile fill-finish manufacturing site effectively implement the CCS? In this presentation I will be sharing about my experience in drafting CCS of a sterile fill-finish process, across the various unit operations and controls

  • Li Wei Chan (Microbiology Manager at MSD International GmbH (Singapore Branch))

    Li Wei Chan

    Microbiology Manager at MSD International GmbH (Singapore Branch)
GMP Compliance When Working With Robotics in Aseptic Processing
Richard Denk

The newest draft of the EU GMP Annex 1 for sterile Manufacturing does mentionen in chapter 2 Princilple the use of Robotics to keep operators away from critical operations. To implement Robotics in a fully automated gloveless aseptic Filling Line in Isolator does require a lot of GMP Considerations for an Holistic Contamination Control Strategy. How this was successfully implemented will be shown in a case study with all the new requirements from the Annex 1 like first air princibles, continuous viable monitoring, new design of stopper transfers etc.

  • Richard Denk (Senior Consultant Aseptic Processing & Containment at Skan AG)

    Richard Denk

    Senior Consultant Aseptic Processing & Containment at Skan AG
Manual Inspection vs Inspection Supported by AI
Louis Doneck

Different inspection methods and technologies are used in the pharmaceutical industry to minimize the risk of unintended particles entering the patient during the injection of parenteral medication. This presentation gives a brief overview of the different inspection methods (from manual inspection to AI-assisted inspection) applied in each stage of the product development process. It will also discuss how to assess the inspection results of a fully automated machine compared to a human manual inspection (Knapp test). Furthermore the presentation will highlight how inspection results can be improved by AI to achieve a better detection rate and to reduce costly false-rejects in production

  • Louis Doneck (Area Sales Manager at Körber Pharma Inspection)

    Louis Doneck

    Area Sales Manager at Körber Pharma Inspection
Panel Discussion and Q&A
Li Wei ChanRichard DenkLouis DoneckRama Tummala
  • Li Wei Chan (Microbiology Manager at MSD International GmbH (Singapore Branch))

    Li Wei Chan

    Microbiology Manager at MSD International GmbH (Singapore Branch)
  • Richard Denk (Senior Consultant Aseptic Processing & Containment at Skan AG)

    Richard Denk

    Senior Consultant Aseptic Processing & Containment at Skan AG
  • Louis Doneck (Area Sales Manager at Körber Pharma Inspection)

    Louis Doneck

    Area Sales Manager at Körber Pharma Inspection
  • Rama Tummala (Q&C Audit Manager, Global Quality Audit & Compliance at GSK)

    Rama Tummala

    Q&C Audit Manager, Global Quality Audit & Compliance at GSK
Closing Remarks
Emily Cheah
  • Emily Cheah (Managing Director of Charles River Laboratories (Singapore))

    Emily Cheah

    Managing Director of Charles River Laboratories (Singapore)

    A pharmacist by training, Emily is currently Senior Managing Director of Charles River Laboratories Singapore (Microbial Solutions) and APAC Technical Operations Lead. Emily oversees the APAC laboratory operations, as well as site operations including R&D / Centre of Excellence, and market development operations. She is oversees technical programme roll outs in APAC and is involved in the evaluation and implementation of new technology & services within the Microbial Solutions division and serves on various committees within the company.

    She received her Ph.D. (Pharm. Technology) from the National University of Singapore and her EMBA from INSEAD.

    Emily is one of the founding members of the PDA Singapore Chapter and has served as a Board Member in various capacities since its inception in 2013.

    Emily is the current President of PDA Singapore Chapter.

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