Pharmacist by education, Rama Tummala has nearly 30 years of pharmaceutical industry experience in Operations, QA, Validations, Technology Transfer, MS&T, Quality and Compliance audits and Greenfield / Brownfield project management.
Rama is currently working with GSK as a Principal Quality Audit Manager operating from Singapore. Rama is conferred with 'GSK Fellow' and is part of GSK Fellowship of Scientific and Technical Excellence. He has previously worked in India with CIPLA LTD., The Himalaya Drug Company and Alcon Labs; in the USA and Singapore with Alcon Labs. He is also currently serving as a PDA Singapore Chapter core board member as Treasurer.
A pharmacist by training, Emily is currently the Senior Managing Director of Charles River Laboratories Singapore (Microbial Solutions) operations, overseeing all aspects of Microbial Solutions' site operations in Singapore. She is also the APAC Technical Operations Lead, responsible for APAC Laboratory Operations. She is involved in the evaluation and implementation of new technology & services with the Microbial Solutions division in APAC and also 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.
Andiyanto is a Consulting Director 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.
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 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).
Ivy Louis is the Founder of VIENNI TRAINING & CONSULTING LLP, holds a Master's degree in Pharmaceutical Sciences and an MBA in Human Resource Management.
Ivy's combined 33 years spanning across teaching, pharmaceutical manufacturing/quality, and service provider experience is distilled into the consultative and educational approaches that her organization-VIENNI Training & Consulting LLP has been delivering from 2010 onwards. The areas of support for pharmaceutical and biopharmaceutical operations rests on building excellence through consulting in parenteral operations and catering to the learning requirements for operating personnel through training & education.
Ivy has been associated with PDA Inc.(www.pda.org) from 2003, as a member. She has been extremely active in spearheading the activities of the Parenteral Drug Association Chapter in India, from 2013 onwards. Ivy has been contributing in the various capacities as a PDA India Chapter Board member between 2013-2019. She has also been a Member of the Steering Committee for Awards in 2017, Member of the Steering Committee for the PDA letter Editorial Committee and a member of the Task Force that is working on an ANSI standard for Quality Risk Management for Aseptic Processing. She is also a member of the Science Advisory Board and holds a position as Member-Board of Directors for PDA Inc.
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.
Shi Ming has over 27 years of experience in pharmaceutical industry. He is currently working for Janssen Pharmaceuticals (family of J&J) as Quality Director of Asia Pacific Supply to manage external suppliers ranging from vaccine, biologic and small volume parenteral drug products. Prior to joining Janssen ShiMing worked for Scinopharm Taiwan where he was the head of quality management overseeing the quality control, quality assurance and compliance functions for the company's facilities in Taiwan as well as in China. Prior to Schinopharm Taiwan, ShiMing spent over 16 years working for Schering-Plough Singapore then Merck (MSD) Singapore in the areas of quality control, quality assurance, technical services for technology transfer and cleaning validation as well as served and technical lead for regional business operation function for third party management in Asia Pacific region.
Shi Ming graduated from the University of Hong Kong with Ph.D in Chemistry and MBA from National University of Singapore.
Samuel is the Head of Operations & Strategy for Novartis biologics plant in Singapore. He has more than 13 years of experience working in biopharmaceutical industry (vaccines and monoclonal antibodies). He possesses the knowledge and excellent overview of how low bioburden and sterile manufacturing plant plans and operates, from receiving raw materials to producing the final sterile product.
Samuel graduated with a PhD in Bioengineering from the Nanyang Technological University, Singapore. He is currently the board member of PDA Singapore Chapter, leading the students and early career professionals subcommittee.
Dr. Hue Kwon has been serving as a Vice President and Quality Team Leader at Samsung Bioepis since April 2020. She leads a global quality team providing GxP quality and compliance oversight for the end -to-end drug development and lifecycle.
Prior to joining Samsung Bioepis, she served as Head of Business Management and Head of Quality and Compliance in Roche, as a member of a senior management team and leading international GxP capability building and interaction with foreign regulatory agencies to influence in the decision making and building consensus.
She also served as a senior advisor consultant in regulatory strategies for multiple organizations and global matrix environment and for digital health strategy, global IT and global operational alignment project in drug development.
Until December 2010, she served at US FDA for about 9 years on the development of regulatory guidance, emerging regulatory strategy and review and data integrity inspections.