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Ziva Abraham
CEO of MicroriteZiva Abraham is the President and Founder of Microrite, Inc., a California based consulting firm providing consulting and training services to pharmaceuticals, biotechnology, medical devices and in vitro diagnostics in the areas of quality assurance, quality control, microbiology, and validation.
She has over 35 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master’s Degree in microbiology with a focus on Mycology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel. She has trained personnel from various industries in microbiology techniques and methods. She uses her extensive experience to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/veterinary use. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective.
Edmund Ang
Senior Technical Expert, Asia Pacific, BioReliance® Biosafety Testing Services, at Merck Group- Improved CMC Biosafety Testing Strategies In-line with ICH Q5A(R2) (Product Demo by Merck)
- Panel Discussion and Q&A
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.
Dr. Alison Armstrong
Senior Director and Global Head of the Technical and Scientific Solutions at Merck- Implementation of ICHQ5A Recommendations for Biosafety of Medicinal Products: What's New
- Panel Discussion and Q&A
Dr. Alison Armstrong is Senior Director and Global Head of the Technical and Scientific Solutions team. She established a client facing scientific consultancy team in 2015. This team is responsible for scientific and regulatory advice and fully supports customers worldwide. Dr. Armstrong has authored a number of articles on trends in biosafety testing and is a member of regulatory taskforce groups related to rapid technologies. She is an invited speaker at global conferences.
Dr. Armstrong holds a PhD in Molecular Virology from the University of Glasgow
Peter Baker
President at Live Oak Quality Assurance LLCPeter E. Baker, President, Live Oak Quality Assurance LLC, has been consulting nationally and internationally since April 2019. Prior to joining Live Oak Quality Assurance LLC, Peter spent 11 years as a U.S. FDA Drug Investigator, with 7 of those years spent working in FDA’s overseas offices located in India, China and Chile. Peter was named FDA Investigator of the Year in 2013 for his work uncovering serious breaches in data integrity and has special interest in big data management and compliance with 21 CFR Part 11. He speaks Chinese (Mandarin) and Spanish and has performed more than 100 foreign drug inspections around the world on behalf of the FDA. His inspection experience includes performing six systems manufacturing inspections of APIs, intermediates, and finished dosage, including complex small and large molecules.
Meow Hoe Boon
Deputy Director cum Senior GMP Auditor, Audit & Licensing Division of Health and Sciences AuthorityBoon Meow Hoe holds a Bachelor’s degree in Pharmacy from the National University of Singapore.
After graduation, he served the commercial pharmaceutical manufacturing industry for 15 years.
He is an active Senior GMP Auditor conducting both local and overseas GMP audits since year 2001. He is also the Deputy Director of Overseas Audit Unit, Audit Branch, Audit & Licensing Division at the Health Products Regulation Group of the Singapore Health Sciences Authority (HSA).
Outside of Singapore, he was an elected Pharmaceutical Inspection Co-operation Scheme (PIC/S) Chairman cum Member of the PIC/S Executive Bureau for year 2018 to 2019. Currently, he continues to serve as the official HSA Representative in the PIC/S Committee of Officials.
Richard Chai
Technical Service Manager, Life Sciences at STERIS Corporation- Contamination Control and Microbiology Session (Part I) - Moderator Introduction
- Panel Discussion and Q&A
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.
Li Wei Chan
Microbiology Manager at MSD International GmbH (Singapore Branch)- Regulatory Updates III - Introduction by the Moderator
- Panel Discussion and Q&A
- Case Study: Expediting Mold Investigations with Biofluorescent Particle Counting (BFPC) Technology
- Panel Discussion and Q&A
- Contamination Control Strategy (CCS) in Sterile Fill-Finish Facility
- Panel Discussion and Q&A
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).
Emily Cheah
Managing Director of Charles River Laboratories (Singapore)- Opening Remarks
- Contamination Control and Microbiology Session (Part II): Introduction by the Moderator
- Panel Discussion and Q&A
- Closing Remarks
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.
Matthew Davis
Inspections Team Lead - Senior Inspector, Manufacturing Quality Branch at Therapeutic Goods Administration (TGA) - Australian GovernmentMatt Davis is a Senior Inspector – Team Leader, inspection section with the Manufacturing Quality Branch. Matt has been with TGA since 2009.
Before joining TGA, Matt held positions in the pharmaceutical industry sector in quality and technical roles, and has spent time in the UK as a GMDP Inspector for the MHRA.
His current role at the TGA involves performing both domestic and overseas inspections of manufacturers. Matt is also the Chair for the PIC/S Working Group on Data Management and Integrity, and is the TGA representative for the PIC/S EMA revision of Annex 1.
Richard Denk
Senior Consultant Aseptic Processing & Containment at Skan AGRichard Denk is working at SKAN AG, headquartered in Allschwil Switzerland as a Senior Consultant Aseptic Processing & Containment. Richard is Member of the PDA ATMP Advisory Board and chairs the PtC of the Manufacturing of ATMPs. Richard also chaired the 2022 PDA ATMP Conference in Brussels and is a Member of the Program Committee of the PDA 2022 Annex 1 workshops. Richard is a member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is member of the ISPE Annex 1 and PIC/s Annex 2A commenting group. Richard is a global recognized subject matter expert on Containment and has developed the containment pyramid.
Louis Doneck
Area Sales Manager at Körber Pharma InspectionLouis is working at Körber Pharma as a Sales Manager for the Inspection business in Markt Schwaben, Germany. He is looking after the regions South East Asia & India helping customers find the right equipment, from manual inspection booths and Lab units to semi- or fully-automatic machines.
His first PDA event in 2019 was at the Taiwan subchapter, introducing a patented technology on how to differentiate air bubbles from other transparent particles in fully automatic inspection machines.
Louis has a M.Sc. in Industrial Engineering and is working for the Körber Group since 2018, starting with a Technical Sales Trainee program.
Walid El Azab
Senior Manager Technical Services at STERISWalid El Azab is an Industrial pharmacist, a Qualified Person and Lean Six Sigma green belt. He is a Senior Manager Technical Services for STERIS Life Sciences. He currently provides technical support related to the contamination control strategy. He leads workshops to improve inspection readiness. He is an active member of the PDA, ISPE, ECA, and A3P with numerous publications. He is a member of the A3P GIC working group draft Annex 1, rouging, contamination control strategy, and ECA task force on the draft EU GMP Annex 1. He leads the ECA CCS task force. He was a planning committee member of the EU Annual PDA Conference (1st and 2nd) and biomanufacturing (1st-4th). He is an Editorial Committee Member of the PDA Letter and a board member of the Belgium Qualified Person (UPIP-VAPI) association and a co-founder of the Belgium QP Academy.
Santhosh Francis
Area Vice President, South Asia and ANZ at Sparta Systems, a Honeywell Company- Delivering Value With a Digital QMS (Product Demo by Sparta Systems, a Honeywell Company
- Deriving Strategic Value from a GMP Compliant Paperless Quality System
- Panel Discussion and Q&A
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.
Rick Friedman
Deputy Director, Office of Manufacturing Quality at US FDARichard 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.
Marc Glogovsky
Business Unit Manager, Microbiology Consulting at ValSource, Inc.- Creating a Microbiology Investigation Playbook
- Fundamentals of an EM Program
- Panel Discussion and Q&A
Marc Glogovsky is currently a senior consultant and manager of the microbiology division with ValSource, Inc. In his current role, he is focusing on development of contamination control strategies, implementation of rapid microbiological methods (RMMs), and establishing risk-based environmental monitoring programs.
Marc has been an active PDA member since 2000 and is currently serving on both the Science and ATMP Advisory Boards and as co-chair of the Microbiology/EM Interest Group. He has co-chaired and contributed to several Technical Reports and Points to Consider documents.
Marc earned his B.S. in Biology from Monmouth University and his M.S. in Microbiology & Molecular Genetics from Rutgers University.
David Keen
Director, Pharmaceutical Microbiology & Consulting of Ecolab Life SciencesDavid 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.
Dinesh Khokal
Director and Regional Lead, External Affairs, JAPAC of Amgen Biotechnology Singapore- Regulatory Updates I - Introduction by the Moderator
- Panel Discussion and Q&A
- Panel Discussion and Q&A
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.
Chee How Lee
Assistant Vice President at Economic Development BoardChee How presently holds the post of Assistant Vice President, Healthcare. He is concurrently part of EDB’s Japan & Korea Desk.
Prior to his current role, Chee How served in EDB’s Medical Technology and Pharmaceuticals & Biotechnology industry sub-groups. He was most recently based in Tokyo, Japan as EDB’s Regional Director and First Secretary at the Embassy of the Republic of Singapore’s Office of the Counsellor (Industry), covering industries including Commercial & Professional Services, Consumer and Healthcare.
Chee How graduated from Hitotsubashi University in Tokyo, Japan with a Bachelor’s degree in Economics.
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.
Pao Chun Lin
Senior QC Specialist at GSK- Implementing the QC Lab of the Future – Automating Endotoxin Testing for Water Samples
- Panel Discussion and Q&A
Pao-Chun joined GSK Vaccine site (Singapore) as a Senior QC Specialist for Analytical Science and Technology team in 2020. She is the Project lead for the introduction of innovative technologies into the QC department in Singapore. Apart from equipment qualification and implementation, Pao-Chun is also responsible for bio-related analytical method validation and ensures compliance to regulatory standards. She is the QC Representative for inspection and has supported on-site regulatory inspections by HSA and EMA.
Pao Chun is an experienced scientist with a demonstrated history of working in biologics industry. Skilled in Stable cell line development, Glycosylation, In-vitro based assays, Monoclonal antibody production, Protein purification and analysis and Confocal Microscopy. She has a strong research background with a Doctor of Philosophy (Ph.D.) focused in Cellular and Molecular Biology from NUS (A-star scholarship).
Robert Lutskus
Director, Informatics Operations, of LonzaRob 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.
Michelle Peake
Senior Consultant, Quality/Biopharma at SeerPharma Pty Ltd- Risk Assessment in Facility Design for Microbiological Control in Cell and Gene Therapy Manufacturing
- Panel Discussion and Q&A
- ATMP Session: Introduction by the Moderator
- Panel Discussion and Q&A
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.
Jo Sherriff
Senior Consultant at Seerpharma- Risk Assessment in Facility Design for Microbiological Control in Cell and Gene Therapy Manufacturing
- Panel Discussion and Q&A
Jo Sherriff is a Senior Consultant with SeerPharma, a consulting firm providing best-practice advice and training to pharmaceutical, medical device and life science companies in the Asia-Pacific region on matters of Quality and GMP compliance.
Jo has over 20 years of experience in the pharmaceutical and life science industry. Jo is a qualified Chemical Engineer with her career spanning roles in process design, site operations, qualification/validation, GMP facility design and development of quality document systems. Jo’s extensive consulting and hands-on experience enables her to provide project management and practical GMP compliance advice from the facility concept design phase through to completion of process validation activities, in readiness for regulatory inspection.
Jo is Treasurer of the PDA Australia Chapter.
Donald Singer
Senior Microbiology Technical Consultant, North America at Ecolab Life SciencesDon 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.
Andiyanto Sutandar
Manager at NNIT SingaporeAndiyanto 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.
Wallace Torres
VP Site Operations at Amgen Singapore ManufacturingWallace I. Torres is the VP Site Operations for Amgen Singapore Manufacturing (ASM). He is responsible for the Biologics and Synthetics manufacturing operations in Amgen Singapore.
Wallace is a Senior executive with experience in achieving Quality, Strategic and business growth objectives internationally and within changing environments. Extensive experience on pharmaceutical quality and manufacturing operations with more than 30 years of experience, Wallace worked for 25 years at Hoffmann La Roche in several positions in the QC/QA, Manufacturing, Strategy, and Supply Chain areas. In 2013 he joined Amgen with responsibilities ranging from Quality director to VP of Manufacturing.
His experience includes responsibilities as Manufacturing Site Head, Global Head of Risk Management, Global Quality Manager, and QA/QC Head at Contract Manufacturing facilities. During the years, he also held several leadership positions in Switzerland, USA, Mexico, Brazil, and Singapore.
He holds a Bachelor degree in Biology from the University of Puerto Rico, a Master in management from the University of Phoenix, a Master in Advance Management Practices from the University of South Australia, and a PhD in International Business Management from the Swiss Business School.
Rama Tummala
Q&C Audit Manager, Global Quality Audit & Compliance at GSK- Regulatory Updates II - Introduction by the Moderator
- Panel Discussion and Q&A
- Contamination Control / Sterile Processing Session: Introduction by the Moderator
- Panel Discussion and Q&A
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.
Dawn Watson
Director, Microbial Control & Sterile COE of Merck & Co., Inc.- Case Study: Expediting Mold Investigations with Biofluorescent Particle Counting (BFPC) Technology
- Panel Discussion and Q&A
Dawn is a Director supporting Microbial Control at MSD. She works in Global Science & Technology Services managing a team that leads and executes global initiatives targeted to proactively address quality and compliance risks in the sterile and low bioburden network while driving continuous improvement. Additionally, her team provides microbial contamination control and sterile manufacturing expertise to resolve critical production issues, develop innovative solutions, and ensure network alignment with industry and regulatory expectations. She is an active member in the Parenteral Drug Association and BioPhorum Operations Group. She has 26 years of experience in the pharmaceutical industry, specifically focused on sterile and low bioburden products including vaccines, therapeutic proteins and small molecules. She is trained and certified in Six Sigma and Change Management. She has held positions in validation, manufacturing and research and development throughout her career with MSD.