Key Tenents

Roseli F Tamaoki Caseiro, Ph.D.

Independent ETS Auditor

Brazil

www.linkedin.com/in/roseliftamaokicaseiro |  rftamaoki@gmail.com

Dr. Roseli F. Tamaoki Caseiro, is agronomist with Master’s and Doctorate degree in Plant Science in the area of Seed Technology and with specialization in Quality Management System. She is Quality Management System Lead Auditor (IRCA Certified) and Integrated Management System (ISO 9001, ISO 14001 and ISO 45001) Lead Auditor (Abendi/RAC Certified), qualified auditor for Excellence Through Stewardship (ETS) and for conduct verifications for Plant Breeding Innovation (PBI) Management Program. Currently, she is studying MBA in Sustainability/ESG. Below are some highlights about her experience:

· Career developed in the area of Quality Management, Quality Assurance, Quality Control and Seed Analysis Laboratory Management, in large companies of the Agribusiness.

· Expertise in internal audits leadership based on the standards Stewardship, NBR ISO 9001, ISO 17025 and ISO 55001.

· Acted in the implementation, certification and quality programs maintenance (Stewardship, ISO 9001, ISO 17025, ISO 55001, and the organization's Global Quality Procdures/Codes of Practice), in line with the company’s strategic goals.

· Responsible in Brazil (inside the company) for organize and participate in the external audit for Insect Resistence Management/IRM (carried out by Global Stewardship Organization) along with the Seeds Development and Commercial team, contributing to the maintenance of the system with the Stewardship Organization.

· Extensive experience in processes continuous improvement, through audits execution, corrective and preventive actions, root cause analysis, change and quality risk management, monitoring of performance indicators, processes mapping as well as decision making and problem solving aimed at ensuring and achieving the Quality’s goals and policies.

· Managed, trained and audited Management Systems: Stweardship, ISO 9001:2015, ISO 55001:2014, ISO 17025:2005, Global Quality Procedures/Codes of Practice and Suppliers, through PDCA cicle, resulting in processes continuous improvement.

· Conducted Global Quality Procedures/Code of Practice audits in partners (tollers, growers and laboratories), contributing to ensure that the entire process carried out by third parties was adopted with the same quality requirements as the organization.

· Implemented integrated audits (ISO 9001, ISO 17025, Stewardship and Global Quality Procedures/Codes of Practice, reducing the number of times in the areas to be audited, streamlining the process.

· Implementation and trainings of the Change Management and Process Mapping, promoting the standardization and application of these tools in different areas.

· Reviewed and reorganized Quality KPIs and supported KPIs review in other areas.

· Member of the organization's internal global team for review, gap analysis and implementation of Global Quality Procedures/Codes of Practice (Document Management, Audit Process, Critical Analysis Meeting and Change Management).

LinkedIn (Roseli F Tamaoki Caseiro)

Renée has comprehensive experience in the agricultural field, initially working in a research laboratory as a chemist, then in the quality assurance field for multi-national corporations in the agricultural chemical and biotechnology industry. She started Perspective Consulting, Inc. in 1994 and began conducting audits in 1999 of research and production facilities working with materials regulated by the USDA and internationally. Renée has been an ETS qualified auditor since the early days of the program as well as a BQMS-certified auditor. In addition to conducting ETS audits, she also provides consulting services in QMS/Stewardship Program design, gap analysis, training and certification readiness. Renée has worked with US companies to help establish robust stewardship programs and has conducted stewardship training and provided guidance/program assessment for facilities in Africa, Europe and the Philippines.

Gary DeLong is VP of Degart Global who has been qualified as an ETS consultant and auditor for over 14+ years. He has equal experience in consulting with agriculture schemes to ISO 9001, Sustainability, GMO / NonGMO, Food Safety, and Biofuels Certifcation programs. Degart Global works globally with clients visiting 6-7 countries per year. We specialize in agriculture research seed production from discovery, laboratory, field, greenhouse, regulatory, seed processing, storage, labeling, and seed inventory programs. Degart Global has consulted with USDA Biotech Regulatory Services (BRS) and worked with most species of plants.

Nicolas is an agronomic engineer with a passion for international relations and regulatory affairs. He started his career in consultancy where he served as the primary liaison for global clients seeking to register their biocide portfolios in the Benelux. A pivotal moment was the transition to Aventis S.A. in 2000 where he immersed himself in the green biotech arena. His adeptness at navigating regulatory landscapes and scientific complexities allowed him to ascend from a local regulatory manager to a global role, championing different projects and collaborations while balancing scientific rigor with public and governmental considerations. His tenure was marked by innovation, as he implemented new internal standards to enhance data consistency and operational efficiency.

In 2019, Nicolas embarked on a new chapter with Perseus as a Senior Biotech Regulatory Specialist. Here, he continues to navigate the intricacies of the European regulatory landscape, assisting clients in navigating complex compliance requirements with precision and expertise.

His commitment to stewardship, leveraging his expertise to navigate regulatory complexities and encouraging responsible and sustainable practices in the realm of biotechnology, lead him to join ETS in 2023 as a qualified auditor and subsequently the Plant Breeding Innovation (PBI) Management Program in 2024, assisting organizations in harnessing the benefits of new technologies.

CARLOS A. GOMEZ is a native Spanish speaker and learned to speak Portuguese during his countless inspections in Brazil.

Carlos earned his BS in Agronomy at the Colombian National University, Bogotá, and an MS in Environmental Engineering in 1993 from the NC State University, Raleigh, NC USA.

Carlos has been a Registered Quality Assurance Professional in GLP (RQAP-GLP) since 2008, and a Qualified Auditor in Excellence Through Stewardship® (ETS) since 2009.

Carlos as an independent auditor has helped agrochemical/biotech companies, sponsors, and contract research organizations to ensure compliance with the USDA-APHIS / GLP Standards. Also, due to his cultural & bilingual capabilities, Carlos has trained in GLP & stewardship field/lab personnel all over the world.

Rod has lifelong experience in agriculture and has been involved consultatively with ag biotech QMS since its inception. After growing up on a Midwest USA farm and completing a B.S. degree in Agriculture from University of Nebraska-Lincoln, he worked several years in an agronomic management advisory role. Rod joined Critereon in 1998, leads its inspection and audit services, has been a qualified auditor/verifier for both the ETS and PBI Management Programs since each program began, and has also been CQA certified and a BQMS-certified auditor. In addition to being available to conduct certification audits and verifications, he also provides consulting services in QMS design, review, authoring, training, gap analysis, and certification readiness.

Phil has deep roots and experience in agriculture and agricultural biotechnology and is now qualified as an auditor for the Plant Breeding Innovation (PBI) Management Program.  He grew up on a farm in the Midwest United States and worked in both technical and commercial roles with a major ag life science company before joining the Critereon team.  Phil was part of the initial class of qualified ETS auditors and has conducted ETS audits on five continents.  He has been a qualified ISO 9001 auditor and a Certified Quality Auditor (CQA), and provides consulting services to develop, improve, train, and assess Quality Management Systems (QMS) for clients in the seed industry.  Phil enjoys working with clients to understand their approach to stewardship and provides positive feedback according to the standard being verified.  He holds B.S. and M.S. degrees in Agriculture from The Ohio State University.

Dr. Dianah R. Ngonyama has broad experience ranging from conducting Gap assessments, to helping organizations with Ag-biotech stewardship training and developing proper policies and procedures, to conducting ETS Readiness and Certification audits. In addition, Dianah has recently (2024) qualified to serve as a Qualified Auditor to conduct verifications for the new Plant Breeding Innovation (PBI) Management Program, that is a global management platform that empowers the development, utilization, deployment and adoption of plant products created through advanced breeding techniques, e.g. genome editing in agriculture.  She is also a certified ISO Internal Auditor, and hence can help with other quality management systems. Having been a research scientist (lab, GH, and Field testing) and biotech stewardship manager at big corporate companies (Monsanto and Simplot) in the United States, and now a university professor and Research Integrity Officer (RIO) at Iowa State, allows Dianah the ability to provide intensive and extensive assessments and audits, as well as providing advisory services on technical details of your Ag product development programs. Internationally, Dianah has been a private consultant for big international organizations (CIP and IITA) helping to develop strong functioning biotech stewardship programs, and successfully attaining ETS certification. Her extensive biotech stewardship experience involves various crops, including corn, soybeans, potatoes, cowpeas, cotton, wheat, canola, bananas etc. Dianah attained her PhD in Agric from University of Wisconsin-Madison, MBA from Maryville University in St Louis, MSc from University of Reading-UK, and BSc Hons from University of Zimbabwe. Hence, Dianah can assist clients from across the world with appropriate guidance, training, developing SOPs, conducting professional audits and inspections, and other consultancy/advisory services.

Dr. Carl Ramage is a seasoned expert in the life sciences sector, with over 25 years dedicated to advancing agbiotech products globally. As Managing Director of Rautaki Solutions Pty Ltd, he specialises in innovation and research excellence, backed by a significant track record in regulatory strategy and process implementation. With a Ph.D. from the University of Queensland and further qualifications from Canterbury University, New Zealand, his expertise encompasses strategy development, project management, and regulatory compliance.

Patrick, a seasoned auditor initially trained in 2008, brings extensive expertise to the table. His background includes training, implementing stewardship programs, conducting preparatory audits, and performing formal ETS audits for a diverse range of organizations. Having firsthand experience with the challenges posed by sensitive detection tools and navigating complex regulatory environments in the biotechnology sector, Patrick firmly believes that the ETS approach provides a holistic solution for organizations. He views mandatory audits as a crucial component of continuous improvement. In 2024, he promptly joined the Plant Breeding Innovation (PBI) Management Program, assisting organizations in harnessing the benefits of new technologies while avoiding potential pitfalls. Based in Europe, Patrick supports clients globally.

During my career, I have led multiple efforts in implementing ISO 9000 at organizations prior to other systems/guides coming online such as Excellence Through Stewardship (ETS). My primary focus has always been applying Quality Principles and Practices in a way that adds value at the individual level, the organizational level, and at the industry/sector level. I have been involved in many facets of organizational policy and procedure development and participated in the development of the current ETS and PBI Guides. Click here for more information.

Originally growing up on a farm in North America, Dr. Jonathan has a background in biotechnology and agriculture in more than 15 countries, including in Asia, Africa, Europe, and Latin America. As both a research scientist and agriculture practitioner, Dr. Jonathan understands biotechnology as well as the practical application for use in the field. Since 2012, Jonathan has resided in Asia where he grows fruit & field crops and provides ETS Members with value-adding services around the world. Utilizing English, Chinese, Spanish, and other languages, Dr. Jonathan’s approach is sincere, direct, detailed, and a positive experience for the benefit of helping your organization improve and grow. So, if you need professional audits, inspections, training, or consulting, etc. please do contact Dr. Jonathan today.

- 28 years of experience in seed industry

> 15 years @ Bayer

- ETS qualified auditor since January 2020

- PBI Management Program qualified auditor from program inception in 2024

- Expertise in seed & traits stewardship and quality management

- Successfully conducted Virtual ETS Audit during COVID 19 Pandemic

- Hands on experience in implementation of ETS program & QMS

- Experience of mentoring international organisations in developing &  implementing stewardship programs

- APAC Regional Head of Seeds Stewardship - Bayer (2011 - 2019)

- Head of Quality Management - Bayer Bioscience, India (2005 - 2011)

Anderson Casarini is an agronomist, ISO 9001 quality auditor, and has experience with ETS Audits since 2015, having conducted audits for DOW and BASF in Brazil. He is a dedicated and assertive professional, always looking for new challenges and updates in Agriculture and Biotechnology areas. Website

Dr. Thompson has recent experience in conducting ETS "virtual audits" and served as a resource person for ETS's "Experiences in Virtual Auditing Webinar.  He is a former member of the ETS Board of Directors. Being a qualitative researcher, he utilizes said techniques when performing program assessments and audits. He has longstanding broad scope experience in the international development arena and has considerable experience across the US and crop kinds conducting 2nd party biotechnology stewardship focused audits. In addition, Dr. Thompson provides mentoring services to other consultants and auditors. Website