Ziva Abraham (CEO of Microrite)

Ziva Abraham

CEO of Microrite

Ziva 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.

Somasundaram G. (Senior Consultant Asia Pacific, Process Solutions at Merck KGaA)

Somasundaram G.

Senior Consultant Asia Pacific, Process Solutions at Merck KGaA

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.

Dinesh Khokal (Director, External Affairs, JAPAC and Intercontinental - LatAm of Amgen)

Dinesh Khokal

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

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).

Terence Lee (Senior Technical Account Specialist at West Pharmaceutical Services)

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.

Morgan Polen (Contamination Control Expert at Microrite)

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 (SME Microbiologist,  Pfizer Global Operations at Pfizer)

Dona B. Reber

SME Microbiologist, Pfizer Global Operations at Pfizer
Sok Tiang (Vice President - Scientific Affairs & Technical Services at West Pharmaceutical Services)

Sok Tiang

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.

Jonas Van Den Berg (Global Quality Manager at Roche)

Jonas Van Den Berg

Global Quality Manager at Roche