Speakers ⇽ 2021 PDA Pharmaceutical Manufacturing & Quality | Parenteral Drug Association on Glue Up

This is a past event. Registration is closed. View other Parenteral Drug Association - Asia Pacific office events.

Ziva Abraham

CEO of Microrite

https://www.microrite.com/

Ziva Abraham is the President and Founder of Microrite, Inc., a California-based consulting firm that provides 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 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.

Peter Baker

Vice President at Green Mountain Quality Assurance LLC

Peter E. Baker, Vice President, Green Mountain Quality Assurance LLC, has been consulting nationally and internationally since April 2019. Prior to joining GMQA, 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.

Hal Baseman

Chief Operating Officer at Valsource Inc

Hal Baseman is Chief Operating Officer and a Principal at ValSource LLC and ConcordiaValsource LLC. He has over 40 years of experience in pharmaceutical operations, validation, and regulatory compliance. He has held positions in executive management and technical operations at several drug manufacturing and consulting firms. He has held positions as the Chair of the PDA (Parenteral Drug Association) Board of Directors, the Co-Chair of the PDA Science Advisory Board, the Co-Leader of the PDA Aseptic Processing Points to Consider Task Force and the Co-Leader of the PDA Process Validation Interest Group, as well as a long-time member of the PDA Training Research Institute faculty. He has been a leader, author, editor and contributor to numerous technical reports, articles, books, and presentations on subjects related to Quality Risk Management, Validation, and Aseptic Processing. Hal holds an MBA in Management from LaSalle University and a B.S. in Biology from Ursinus College.

Lisa Bennett

Senior Quality & Compliance Specialist at Cell Therapies

Li Wei Chan

Manager, Microbiology at MSD International GmbH

Li Wei is a microbiologist with experience in cleanroom, utilities, product testing and microbial controls in the pharmaceutical and medical devices industry (sterile & non-sterile manufacturing facilities). He is currently responsible for developing microbial control strategies, developing microbiological test methods, managing environmental monitoring program and managing laboratory compliance to corporate and pharmacopoeial standards. He also supports regulatory inspections e.g. FDA, PMDA, HSA, customer inspections, conduct internal inspections and managing QC audit program. Li Wei received his Bachelor of Science (Biotechnology) from Monash University, and is a certified GSK quality auditor.

Olivier Chancel

Quality Auditor, Sterility Assurance Expert at Boehringer Ingelheim

Olivier Chancel is a Doctor Pharmacist WHO graduated with degrees in Technological Pharmacy, Quality Control and Management. He is working for Boehringer Ingelheim as a Sterility and Aseptic Practice Assurance Expert and Senior Quality Auditor. He has been working in or with the pharmaceutical industry for 20 years at various positions including pharmaceutical research and development, Quality Assurance, Quality Control, project management and production for both solid and injectable dosage forms.

He has published a number of papers in peer-reviewed journals relating to cleanroom activities or aseptic practices, has cowritten several books and also presented/moderated at various industry forums in Europe, Asia and the US (PDA, A3P, SFSTP, SMI, ASPEC, ECA, PHARMIG...)

Emily Cheah

Managing Director of Charles River Laboratories (Singapore)

A registered pharmacist, Dr. Emily Cheah is currently the Managing Director of Charles River Laboratories Singapore (Microbial Solutions). Emily oversees strategic technical operations and market development in Singapore, Malaysia, and Indonesia; and is involved in the implementation of new technology/services at the Singapore site. She also conducts numerous training for the Industry. She received her Ph.D. (Pharm. Technology) from the National University of Singapore and EMBA from INSEAD.

Emily is President-Elect of the PDA Singapore Chapter and is an active volunteer with the Chapter since its inception in 2014.

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.

Somasundaram G.

Senior Consultant Asia Pacific, Process Solutions at Merck KGaA

https://www.merckgroup.com/en

Somasundaram G. is a Senior Consultant at Merck Life Sciences‘ Asia Pacific Process Solutions Division based in Singapore. He provides customers with consulting services in training and BioPharmaceutical applications. Previously, Somasundaram headed the Technology Management team for South Asia & Oceania. His team of Technology Managers worked with customers in Product Adoption and trained them in best practices. For the last 19 years, he worked in different capacities within Merck and Millipore. He also worked for a year in QA/QC and another year of academic experience in Microbiology.

He is also an active member of PDA and ISPE, and works closely with these societies‘ Asia Pacific teams.

Somasundaram earned a Post-Graduate Degree in Food & Industrial Microbiology & Business Management.

Chris Garvin

Director of Digital Manufacturing, Process Development at Amgen Inc.

Chris Garvin is the Director of Digital Manufacturing within Amgen’s Process Development organization. His team is responsible for applying predictive models and advanced process control to improve reliability and efficiency across the company’s global manufacturing network. He previously worked in Amgen’s Supply Chain organization and in Manufacturing Sciences at Biogen. Chris has a bachelor’s degree from Williams College, and master’s degrees from Cornell University and the Massachusetts Institute of Technology, where he was part of the Leaders for Global Operations program. Chris is based in Rhode Island, USA.

Eoin Hanley

Associate Director of CSL Behring

Eoin is currently an Associate Director Quality Assurance Compliance with CSL Behring. Eoin has worked in the pharmaceutical & biotech industries in Europe, the USA, and Australia/Pacific, with some of the largest companies in the world. He has experience in a variety of roles within Quality, Engineering, Qualification/Validation and consulting. Eoin has worked on a range of products from API's to sterile medicinal products, including blockbuster recombinant proteins. Eoin’s experience comes from a background in Analytical Chemistry and an MSc. in Pharmaceutical Validation. He also has a passion for keeping up to date with current regulatory and industry trends, as well as the application of lean and operational excellence approaches.

Kurt Jaecques

Senior Manager Sterility Assurance, Global Quality at GSK Vaccines

Kurt Jaecques has 25+years of experience within the pharmaceutical industry. He is working for GSK Vaccines as Global Aseptic Technologies Lead within the Global Sterility Assurance organization. He started his career at MSD (formally Schering-Plough Pharmaceuticals) responsible for the qualification of lab equipment and as lab supervisor Quality Operations microbiology. He worked for CMO’s and start-ups as Microbiology Manager or as consultant. He built up an extensive expertise in pharmaceutical microbiology with specific focus on Environmental monitoring and clean utilities. Kurt holds a Master degree in biochemical Engineering.

Dinesh Khokal

Director, External Affairs, JAPAC and Intercontinental - LatAm of Amgen

https://www.amgen.com/

Dinesh is the Director, External Affairs Quality, at Amgen Biotechnology Singapore supporting Amgen’s outward facing efforts in Japan Asia Pacific and Latin America. He collaborates effectively with industry peers and regulators to engage, understand, translate and deliver impact in the evolving external GxP landscape. Additionally, Dinesh currently holds the position of Adjunct Associate Professor at the Faculty of Health and Medical Sciences, Taylor’s University, Malaysia.

Prior to Amgen, Dinesh held the role of Director of Therapeutic Products Branch at Health Sciences Authority, Singapore. During his 10 years 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 is the immediate past President of PDA Singapore Chapter and he is currently on the PDA Regulatory Affairs and Quality Advisory Board (RAQAB).

Sok Tiang Koh

Vice President - Scientific Affairs & Technical Services at West Pharmaceutical Services

Sok Tiang is an industrial pharmacist with extensive experience in the life cycle mgmt. of injectables from its packaging requirements to the manufacturing in the final finishing for market in a regulated environment. Currently the Vice President - Scientific Affairs & Technical Services for Asia Pacific, she joined West as the Regional Technical Services Manager after extensive experience in aseptic manufacturing in a multinational pharmaceutical company. Over her tenure in West, she has taken on differing roles of increasing responsibilities, from Business Development to Marketing and R&D.

With her training and experience, she provides technical solutions to address the customers in their pharmaceutical containment and delivery system challenges. In addition, she also offers insights in industry trends and regulatory requirements to support their needs.

Sok Tiang holds a Bachelor of Science in Pharmacy with Honors and MBA from the National University of Singapore.

Terence Lee

Senior Technical Account Specialist at West Pharmaceutical Services

Terence is currently a Senior Technical Account Specialist in West Pharmaceutical Services. He is responsible for providing technical advice and support to pharmaceutical companies in the Asia Pacific region. Terence is also actively engaged in projects which reinforce West’s technical market presence and thought leadership. Prior to West, he worked as a Research Scientist developing functional coatings at Evonik’s Smart Surface Solution (S3) Competence Center. Terence is also a part time Adjunct Lecturer at Singapore Polytechnic for the Specialist Diploma course in Formulation Science and Technology. He received his Ph.D. in Material Science and Engineering from Nanyang Technological University with a specialty in stimuli-responsive polymers for environmental applications.

Bruce Loxley

Senior GMP Compliance Advisor at GlaxoSmithKline Vaccines

Bruce Loxely performs regional and global auditing of GSK Vaccines and third party provider sites and functions focusing on Asia Pacific. He has 29 years in the Pharma and Vaccines businesses, variety of roles in Validation and Compliance in both Drug Substance and Drug Product Manufacturing in UK, France and Singapore.

Bruce has been a PDA Singapore Chapter member since 2014. Since February 2020 he has been PDA Singapore Chapter President.

Michael J. Miller

President at Microbiology Consultants, LLC

Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology and the validation and implementation of rapid microbiological methods (RMM). He is currently the President of Microbiology Consultants, LLC (http://microbiologyconsultants.com) and owner of http://rapidmicromethods.com, a website dedicated to the advancement of rapid methods within healthcare related industries.

For 30 years, he has held numerous R&D, manufacturing, quality, business development and executive leadership roles at multinational firms such as Johnson & Johnson, Eli Lilly and Company and Bausch & Lomb. In his current role, Dr. Miller provides technical, quality and regulatory solutions in support of RMMs, sterile and non-sterile pharmaceutical manufacturing, contamination control and GMPs.

Dr. Miller has authored more than 100 technical publications and presentations and is the editor of PDA’s Encyclopedia of Rapid Microbiological Methods. He currently serves on the editorial and scientific review boards for American Pharmaceutical Review, European Pharmaceutical Review and the PDA Journal of Science and Technology. Dr. Miller is the chairperson for PDA's Technical Report #33 and currently serves as an advisor to the USP Microbiology Expert Committee in the area of rapid sterility testing.

Dr. Miller holds a Ph.D. in Microbiology and Biochemistry from Georgia State University.

Tracy Moore

Expert GMDP Inspector at Medicines and Healthcare products Regulatory Agency (MHRA)

Tracy has been a Medicines Inspector for 10 years and prior to joining the MHRA worked in the pharmaceutical industry for 22 years working across most dosage forms within quality and technical roles, acting as a EU Qualified person for sterile products. Tracy is part of the MHRA Annex 1 drafting group contributing to the drafts on an ad hoc basis where needed. During the COVID-19 pandemic period, Tracy has held a key role in the MHRA Task Force for medicine supply chain stream including advising on sterile vaccines manufacture for emergency use and medicine and vaccines supply chains.

Di Morris

Clinical Auditor at AstraZeneca

Kevin O'Donnell

Market Compliance Manager at Health Products Regulatory Authority

Kevin is Market Compliance Manager at the Health Products Regulatory Authority (HPRA, formerly known as the Irish Medicines Board), in Dublin, Ireland. He has been with the HPRA/IMB since 2001 and is a Senior GMP Inspector. He is also responsible for a number of compliance-related programmes at the HPRA, including the Quality Defect and Recall programme, the Sampling and Analysis programme, and the Advertising Compliance programme. He obtained his Ph.D. in the field of Quality Risk Management (QRM) from the Dublin Institute of Technology in 2008. He is currently Chair of the PIC/S Expert Circle on QRM.

Marjo Peters

Director Drug Product Technical Steward Europe of AstraZeneca

Marjo Peters is part of the Global Technical Operations group for Drug Products and Combination Products at AstraZeneca. As part of her current role she is responsible for the technology transfer and technical support for the commercial manufacture of biological products at the European manufacturing sites (both internally and CMO’s) for AstraZeneca. She is based out of the Nijmegen Manufacturing Facility located in the Netherlands, where she previously worked as Director of Manufacturing, Science & Technology for 10 years. Before joining AstraZeneca, Marjo worked for Organon (a Dutch based pharmaceutical company), where she was involved in the formation of a small scale CMO called BioConnection.

Jim Polarine Jr.

Senior Technical Service Manager at Steris Corporation

https://www.steris.com/

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for twenty years. His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection, microbial control in cleanrooms and validation of disinfectants. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active on the PDA’s COVID-19 Task Force and the PDA’s Microbial Excursions Task Force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine teaches industry regulators as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee. Mr. Polarine currently teaches the cleaning and disinfection course as part of the PDA Aseptic Processing Course, IEST, and at the University of Tennessee Parenteral Medications Course. Mr. Polarine is the current President for the PDA Missouri Valley Chapter and Technical Coordinator for the IEST. He is also a leader on the PDA’s Chapter Council Steering Committee. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. He previously worked as a clinical research manager with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois. His main hobby is storm chasing and is very active in tornado research and tornado safety.

Morgan Polen

Contamination Control Expert at Microrite

Morgan Polen is a subject matter expert on contamination control, airflow visualization, and particle monitoring in cleanrooms with over 35 years of industry experience.

He is a member of the ISO Technical Committee 209 (Cleanrooms and Associated Controlled Environments) and a board member of IEST and has been instrumental in drafting and editing international cleanroom standards and best practices. He has extensive experience in working on cleanroom projects in the United States, Canada, Mexico, Germany, Malaysia, Taiwan, South Korea, Singapore, Thailand, China, Philippines, India, and Turkey and is a valuable resource in addressing contamination control in critical environments for the electronics, aerospace and healthcare industries.

As a key member of Microrite’s Expert Contamination Control team, Morgan is instrumental in the development of proactive contamination control strategies through pragmatic risk assessment, troubleshooting contamination issues, and helping with FDA 483/warning letter remediation activities.

Dona B. Reber

Former SME Microbiologist, Pfizer Global Operations at Pfizer

Contamination Control and Environmental Monitoring

Dona has recently retired after 42 years as a Subject Matter Expert microbiologist in the bio pharmaceutical industry. Most recently she was the Director/Team Leader for the Microbiology and Aseptic Support Team, Global Quality Operations for Pfizer, where she received an award for her work in supporting the Pfizer-Bio N Tech Covid vaccine effort. Her professional activities have included policy standards development, global networking support, investigations and troubleshooting for aseptic/non aseptic manufacturing facilities, microbiology testing support and aseptic training. Her passion is sharing knowledge of microorganisms and how they can affect the manufacturing environment. She has published several books and articles and presented at PDA numerous times on this subject. She has been a co author on several PDA Technical reports, most recently the draft Contamination Control Strategy and TR#13 revision draft, as well as Evaluation of Organisms, and Disinfection. She has provided training on PDA TR#13 for over ten years, including for new inspectors, and welcomes the opportunity to present at this meeting on this subject.

Tim Sandle

Head of Microbiology, Quality Risk Management & Sterility Assurance at BPL

Dr. Tim Sandle is Head of Microbiology, Quality Risk Management, and Sterility Assurance at BPL and a visiting tutor at the University of Manchester and University College London. Dr. Sandle has written 30 books and over seven-hundred publications relating to microbiology, pharmaceutical and healthcare sciences. Dr Sandle’s microbiology website is: www.pharmamicroresources.com

Vishal Sharma

Co-Founder of Vienni Training and Consulting LLP

Vishal Sharma, is the Co-Founder of VIENNI TRAINING & CONSULTING LLP, holds a Masters degree in Microbiology, with rich experience of the pharmaceutical industry. Vishal’s early years of being in the pharmaceutical industry in microbiology helps him, continuously, in being a solution provider to Microbiology Functions, with his exposure of facing regulatory audits. This experience adds value to the various discussions that he has during the training that he conducts in pharma and biotech organizations, from research and development to manufacturing process monitoring. Vishal, having handled the Validation Laboratory establishment & functioning for filtration and validation of sterile products, excels in trouble shooting, especially in aseptic areas, microbiology, and sterilization using Statistical Approaches (Six Sigma Certification from Indian Statistical Institute, Bangalore). Vishal has added to the development of learning in organizations through optimization of processes and initiating alternate methods of learning. He has been an advocate of having the training outcomes being implemented during daily work, and with implementation of consulting ideas for daily efficiency enhancement.

Vishal participates in, and leads the activities of the Parenteral Drug Association’s India Chapter, as the President-Elect of the Board. Vishal participates in the Quality System Interest Group that harnesses the power of Knowledge Management, as a subgroup. Vishal is also part of the task force, which published Remote Inspections PTC, published by PDA Inc.

Don Singer

Senior Microbiology Technical Consultant at Ecolab

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 is currently 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 is chair of the PDA Task Force for the Technical Report 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 member of the PDA Task Force for “Contamination Control Strategy” TR. 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 35 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.

Wei Sun

President at Engsysco Inc.

Mr. Sun is an ASHRAE Fellow, he is former chairman of ASHRAE technical committee TC9.11 (Clean Spaces). Mr. Sun is a member of ASHRAE technical committee TC9.6 (healthcare facilities) and TC9.10 (laboratory systems). Mr. Sun has served as chairman of ASHRAE Chapter Technology Transfer Committee. He is current chairman of ASHRAE Environmental Health Committee. Mr. Sun is the Principal Author of “ASHRAE Design Guide for Cleanrooms” book, and a co-author of PDA’s “Cleanroom Contamination Prevention & Control” book. Mr. Sun is an ASHRAE Distinguished Lecturer and has been providing numerous conference speeches over 30 countries, he received ASHRAE Distinguished Service Award and Exceptional Service Award.

Outside of ASHRAE, Mr. Sun has served as a research proposals expert panel reviewer for US NIOSH/CDC and DOE. Mr. Sun is chairman of the National Environmental Balancing Bureau’s (NEBB) cleanroom performance testing committee, was president of the Institute of Environmental Science and Technology (IEST), and is a United States delegate for ISO 14644 cleanroom standard.

He currently serves as the President at Engsysco, Inc. in Michigan, an engineering design firm specialized in sophisticated pharmaceutical cleanroom, hospital and laboratory designs.

Jessica Teo

Division Director, Audit and Licensing Division, Health Products Regulation Group of Health Sciences Authority Singapore

Ms Jessica Teo is the Division Director of the Audit and Licensing Division (ALD), which is the national medicines regulatory inspectorate in Singapore. The Division comes under the Vigilance, Compliance and Enforcement Cluster (VCEC), Health Products Regulation Group (HPRG), Health Sciences Authority (HSA), Singapore. Ms Teo has 18 years of experience as a regulator and a GMP lead auditor at HSA. She currently oversees the audit and licensing of manufacturers, importers and wholesalers of therapeutic products, ensuring that these manufacturers and dealers meet legislative requirements such as Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards through pre-approval and regular audits.

Jonas Van Den Berg

Quality Manager, Global Quality Control at Roche

Jonas van den Berg is currently the Quality Manager in Global Quality Control at Roche in Mannheim, Germany.

He is a subject matter expert for rapid microbiological methods and has experience in pharmaceutical operations, analytical QC, and qualification/validation. In his role, he is involved in the implementation of new QC technologies. He is the project manager for the implementation of the Celsis Rapid Sterility Test. Prior to Roche Jonas worked as a consultant for microbiological method development in the pharmaceutical industry.

Jonas is a member of the BioPhorum’s Alternative Sterility Test Team. He has received his Ph.D. in microbiology and biochemistry from the University of Groningen, the Netherlands.

Speakers

Ziva Abraham

Peter Baker

Hal Baseman

Lisa Bennett

Li Wei Chan

Olivier Chancel

Emily Cheah

Rick Friedman

Somasundaram G.

Chris Garvin

Eoin Hanley

Kurt Jaecques

Dinesh Khokal

Sok Tiang Koh

Terence Lee

Bruce Loxley

Michael J. Miller

Tracy Moore

Di Morris

Kevin O'Donnell

Marjo Peters

Jim Polarine Jr.

Morgan Polen

Dona B. Reber

Tim Sandle

Vishal Sharma

Don Singer

Wei Sun

Jessica Teo

Jonas Van Den Berg

This is a past event

Parenteral Drug Association - Asia Pacific office might have other events you're interested in.