2025 - August ASQ Orange Empire, Section 0701, Monthly Meeting

Combination products are emerging as innovative medical products due to their contribution to advancing medical care and are thus expected to have major impact in the coming years. Future technologies are most appealing to patients with ongoing medical conditions that require consistent treatment with daily injections or weekly procedures and unmet medical needs. Overall, the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges.

New tools of computational modeling and simulation, novel technologies such as artificial intelligence, needs of developing new standards, evidence-based research methods, new approaches including the designation of innovative, or breakthrough medical products have been developed and could be used to assess the safety, efficacy, quality, and performance of combination products. Taken together, the fast development of combination products with great potential in healthcare provides new opportunities for the advancement of regulatory review as well as regulatory science.

Upon completion of each session, participants should be able to:

• Analyze latest regulatory expectations and challenges
• Understand potential future innovation platforms
• Acknowledge potential and future Global Convergence/Harmonization intiatives for combination products
• Understand the regulatory challenges and opportunities ahead

James has 23+ years of experience in increasing quality operations, quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Medical Devices, Technology Medicinal Delivery Platforms, Complex Generics, Companion Diagnostics, Digital Medicine, and Combination Product areas. Regularly provide AbbVie therapeutic franchise units regulatory counsel and strategy to all aspects within the quality management system and regulatory affairs. Contact Numbers: +1 714 425 2164; Email: [email protected]

INDUSTRY:

CMC Global Dossiers/Global Device Regulatory Strategies

EU MDR/IVDR – Person Responsible for Regulatory Compliance (PRRC)

21 CFR Part 3 and Part 4 - Combination Products, CE Marking, ISO 13485:2016/MDSAP

International Regulatory Affairs Represent AbbVie as the U.S Agent regarding FDA matters for international medical device facilities Actively participate in industry trade organizations and serve on standards committees. Member of various regulatory and quality work groups including DIA, RAPS, AAMI, ISPE Combination Products (CoP), OCRA, SDRAN, ASQ Orange Empire Section, and ASQ San Diego. Recognized international speaker, chair, and keynote at various regulatory symposia, Chairman of the DIA Combination Products Committee, and a moderator for various global regulatory panel discussions. Lecture various sections for the RAPS RAC/RCC Device Certification Prep Course - SDRAN. Adjunct Assistant Professor at the University of Southern California (USC) – School of Ph*rm*cy – Regulatory and Quality Sciences.

EDUCATION

2000 - BSc., Biology, Duquesne University

2002 - MHMS, Health Law and Policy, Duquesne University

2011 - Certificate, Health Law and Life Science Regulatory Compliance, Seton Hall University Law School - Center for Health & Pharmaceutical Law

2022 - Certificate, RAPS Executive Development Program, Northwestern University - Kellogg School of Management

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Design of Experiments (DoE) is a statistical approach for planning, conducting and analyzing structured experiments in an effort to identify the relationship between input parameters (known as factors) and output variables (known as responses). DoE is a powerful tool used for problem solving in various manufacturing, service and other industries. Generally it can be perceived as expensive, complicated, intimidating, and difficult tool to use by practitioners, hence somewhat underutilized.

Understanding the DoE fundamental concepts and prepare for a well-planned experiment is the main key to success. This presentation covers key concepts such as design types, considerations, design stages along with real world examples from manufacturing case studies.

By attending this clinic presentation, you will

• Learn DoE definitions and fundamentals
• Understand various types of DoEs
• Learn the application of each DoE type and when and how to use them
• Gain insight on how to analyze and interpret the results
• Learn about general guidelines and best practices.

Greg Golamirians is Director of Operations at Marvin Land Systems, a defense contractor involved with product development and manufacturing of various systems for defense, aerospace and military vehicles. With over 25 years of field hands on experience he is specialized in diverse range of expertise including manufacturing, operations excellence, quality and reliability, process development and improvement methods. He also has extensive experience in leadership, strategy development and execution, engineering, project management and financial acumen.

His background spans across multiple industries, namely medical device, aerospace and defense, semi-conductor, automotive, HVAC, material handling and consumer goods. He is very passionate both as professional and mentor with delivering specialized trainings and coaching to support practitioners on gaining technical insights in their daily operations as well as mentoring and assisting them to succeed and excel in their careers.

His accomplishments include successfully leading various process improvement initiatives to reduce scrap, cost, cycle time, defects as well as improving yield, design for manufacturability, process automation and improvements projects, and implementing lean manufacturing and quality management systems for various industries.

He has B.S. and M.S. In Industrial & Manufacturing Engineering as well as MBA in Finance from California State University Pomona. Also he holds PMP, CSSBB, CRE, CQE, and CQLA certificates .

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