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.
Mr. Arista is currently Field Investigator National Expert Pharmaceutical & Biotechnology with FDA’s Office of Regulatory Affair’s Office of Pharmaceutical Operations. Mr. Arista is one of ORA’s National Expert Investigators in pharmaceutical and for the past 30+ years has accumulated a global appreciation and technical expertise with respect to pharmaceutical manufacturing and Quality Control tests.
Mr. Arista has been with the FDA for a number of decades and most recently was the previous Deputy Director of FDA’s Office in New Delhi, India. He has worked with a number of international standard organizations that established internationally recognized standards e.g., American National Standards Institute (ANSI), Association for the Advancement of Medical Instrumentation (AAMI) and with the Parenteral Drug Association (PDA) committees regarding Microbiology.
He has worked with recognized health authorities from around the world that include, for example, the WHO’s International Consultation of Experts to Review the WHO Programme Policy, Process and Indicators for Strengthening NRAs Regulating Health Products and Technologies; the Pharmaceutical Inspection Convention / Scheme (PIC/S) regarding regulatory global compliance, and as the Co-rapporteur of PIC/S Joint Assessment and Inspection (2015) of COFEPRIS (Mexico - Comisión Federal para la Protección contra Riesgos Sanitarios/ Federal Commission for the Protection against health risks).
Mr. Arista has teamed with a number of regulators from around the world e.g., MHRA, EMA, EDQM, WHO, SwissMedic, Santé Canada, Therapeutics Goods Administration (TGA – Australia), China FDA, Japanese Ministry of Health & Welfare and with the Nigeria National Agency for Food and Drug Administration and Control (NAFDAC).
Hal Baseman is Chief Operating Officer at Valsource Inc. He has over 40 years in pharmaceutical industry and has held previous PDA positions as Board Chair, SAB Co-chair, Co-leads for Aseptic Processing Points to Consider, Process Validation IG, TR 22, 44, and 60, and long-time member of TRI faculty. He is on the Isolator Points to Consider, QRM for Aseptic Processing Standards task forces, PUPSIT committee, Co-chairs the Annex 1 team, Portfolio Steering Committee, and MSOP. Hal holds an MBA from LaSalle University and B.S. Biology from Ursinus College.
Josef Burgmaier graduated in Chemical Engineering in 1999 at the university of Furtwangen/Germany. He started his career with febit ag, a biotech start-up company in Mannheim/Germany, working as development engineer for a DNA analysis device, later becoming responsible for the biochip surface treatment operations. In 2004 he joined Johnson&Johnson at the Janssen/Cilag site in Schaffhausen/Switzerland as project engineer in the sterile filling and freeze drying area. In 2006 he became the technical lead for this department. In 2011 he was project lead to implement the SAP PM module at the site. He was key user for the system and acted also as lead in the global SAP PM community after the implementation. In 2016 he led the implementation of a mobile front end to SAP PM based on the Neptune UX platform. In 2017 he became the head of calibration of the Schaffhausen site. In November 2019 he joined the Asset Management Center of Excellence team in the Pharma sector of Johnson&Johnson as Senior Manager, being responsible for the strategy to implement manufacturing for the future-technologies like Runtime/Condition Based Maintenance and a statistical approach to optimize calibration frequencies.
Brice Chasey is a Senior Product Manager with over 10 years of industry experience including rapid microbial detection methods. Across many years of validation and implementation, interacting directly with industry analysts bringing rapid detection systems to routine use, Brice now manages the Celsis rapid microbial detection product portfolio at Charles River. He received a Bachelor of Science in Microbiology from Arizona State University. He currently resides in Phoenix, Arizona, working for the Microbial Solutions division of Charles River Laboratories.
Somasundaram Gopalakrishnan, works as Senior Technical Consultant for Asia Pacific in Merck Life Sciences under the Process Solutions division based in Singapore. He does consultation with Biopharmaceutical customers for Regulatory compliance, Training and Process Unit Operations. Previously, Somasundaram was leading the Technology Management for S.E.A and Oceania handling a team of Technology Managers working closely with customers in Product Applications and training customers in best practices. Somasundaram has worked in different functions within the organisation for the last 18 years in Technical Service, Filter Validation Lab, Product Marketing, Commercial role and Business Development areas. He also worked in Quality Control (Microbiology), and Academic experience in Microbiology.
Somasundaram graduated with a Master Philosophy in Food & Industrial Microbiology, and Post graduate in Business Management.
Choon Wee is one of the Senior Compliance Audit Managers from Pharma Global Technical Operations Quality and Compliance Audit of Roche. His main responsibility is to carry out GMP and compliance audits on internal and contract manufacturing sites, covering both commercial and investigatory medicinal products and API. He joined Roche since 2018 and prior to that, he was a GMP inspector from Health Sciences Authority Singapore for 15 years. Currently, he is one of the task force members in PDA to develop Standard for Cryopreservation of Cells Used in Cell Therapies and Regenerative Medicines.
Mr. Gabriele Gori has been in the sterile Pharmaceutical / Vaccine/Medical Device business since 1994 – in different local and global roles in multinational companies, including, but not limited to, Bausch & Lomb, Novartis and GlaxoSmithKline.
His experience covers R&D, Engineering, Quality Control, Quality Assurance and GXP Compliance: since September 2015 he has been in role as Vice President, Global Head of Audit and Risk Management at GlaxoSmithKline Vaccines.
In Ulrich's current role at Charles River, he leads a global team of Technology and Market Development Managers for the Microbial Solutions division.
Dr Herber is co-author of scientific papers on new methods applied in microbiological quality control. He has held several talks covering developments in the area of rapid microbiological methods and is an Advisory Board Member of the Pharmaceutical Microbiology Working Group at the European Compliance Academy.
Andrew was has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His career history covers a number of areas over approximately 35 years.
Currently Andrew is a Director of Compliance at Abbvie the role includes Auditing of manufacturing sites, Training and mentoring, and interaction with regulatory agencies.
Prior to this Andrew was an Inspector with the MHRA for nearly 14 years.
Maik W. Jornitz, President and CEO of G-CON Manufacturing Inc., is a technical expert with over 30 years of experience in bioprocesses, especially sterilizing grade filtration and single-use technologies, including regulatory requirements, integrity testing, systems design, and optimization. Jornitz has published 11 books, 18 book chapters and over 100 scientific papers. He is the former Chair of the PDA Board of Directors and Science Advisory Board, and member of multiple PDA Task Forces. He is working member of Biophorum, ASTM, an advisory board member of the Biotechnology Industry Council, ICAV and multiple science journals. He recently has been recognized as one of the top ten global industry influencers. As a faculty member of various training activities, including PDA TRI, he trains members of the industry and regulatory authorities on a frequent basis. He received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland.
Dinesh is currently responsible for Amgen’s outward facing efforts in Japan Asia Pacific and Intercontinental Latin America. He collaborates effectively with industry peers and regulators to engage, understand, translate and deliver impact in the evolving external GxP landscape.
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.
Yvonne serves as Executive Director, Amgen Singapore Biologics Plant. She leads the operation and development of the manufacturing organization and infrastructure associated with this facility.
Her previous role as Director, Quality Assurance, provides Quality leadership and oversight to Amgen plant operations. Since joining Amgen in 2016, she leads the team through phases of facility design, commissioning, process qualification, regulatory approval and market supply of the API plant. She has also led the Quality Control laboratories for raw material testing, quality floor support, product testing and release.
Di is qualified with MRSC Chemistry and Post Graduate Diploma Industrial Pharmaceutical Science and is a Qualified Person under permanent provisions since 1993.
Di has worked in the pharmaceutical industry for over 40 years this includes a number of years as a Medicines Inspector for the MHRA. Di has worked in the areas of Quality Control (Chemistry and Microbiology), Quality Assurance, Regulatory Affairs and Compliance Auditing and has worked with a wide range of dosage forms including sterile products, biological, and non-sterile dosage forms.
Mícheál O’Hehir is currently an Engineering Compliance Manager in GSK’s central Pharma Supply Chain team. In this role he is the lead author of GSK’s global engineering standards and a lead auditor in GSK’s engineering audit programme for Pharma and Consumer manufacturing sites worldwide. He is also a regular auditor on central Quality and EHS audits of these sites. He has 30 years professional engineering experience in a broad range of engineering leadership roles, with 22 years’ experience in primary API sites. His main areas of expertise are in maintenance, change control and service contracts. He is based in Ireland.
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.
Stephan works in the Quality External Affairs organization in Amgen organizing the policy for Operations and CMC with focus on Europe / International since 2013. He collaborates cross-functional internally and externally including authorities and associations on topics regarding QM, GMP/GDP and CMC topics by shaping regulatory guidelines, disseminating intelligence, and educate on related matters.
Stephan also represents Amgen in EFPIA, in the ICH training committee and ICH-QDG. He was a member of Q9, Q-IWG and Q7 teams at ICH. In PDA he is an elected director of the board, chaired RAQAB and the Inspections Trends Interest Group.
Rico is a registered pharmacist from Germany. He holds an additional degree in Economics. Before working for the Ministry of Social Affairs and Consumer Protection of the German Federal State of Saxony, he used to work as GMP and GDP Inspector with the Local Inspectorate in Dresden. For around 20 years, Rico performed GxP inspections worldwide. Now he is involved in legislative processes on both EU and German national level.
David has over 37 years’ experience in the pharmaceutical industry in Australasia and the ASEAN regions, specializing in training and compliance to FDA, TGA and PICs codes of GMP, including the manufacture of sterile products. David’s breadth of experience covers production, laboratories, supply chain, quality assurance, sales and marketing, training and consulting. He has worked for large companies such as GSK and has successfully (part) owned and managed small pharmaceutical companies, growing them to category leaders in the Australian market. David is currently a Partner with a consulting firm based in Australia and Singapore, and has carried out work in many of the ASEAN countries. He is responsible for the management of the training department and creates and delivers the majority of training courses. He has also lectured many of the subjects in the Master of Good Manufacturing Practice Degree, that his consulting firm owns and delivers in conjunction with the University of Technology Sydney. He has been a committee member of the PDA Australian Chapter for the past 7 years and was President in 2016-17.
Dr. Tirumalai has been at the USP since 2003 and is currently a Principal Scientific Liaison-General Chapters in the Science Division. He is the Liaison to the USP Expert Committee on Microbiology. He works with the industry, regulatory agencies and other external science based organizations in the development and revision of General Chapters. Dr. Tirumalai represents USP on PDA expert task forces and committees related to Microbiology and Sterility Assurance 2005-till date, the organizing committee of PDA Global Microbiology Conference 2006-2018, on AAMI expert working groups related to Microbiology, Sterilization, Sterility Assurance and Biocompatibility 2004-till date, and on the editorial board of FDA’s Pharmaceutical Microbiology Manual.