Director, Quality Systems

m.miller@rcainc.com

Michael Miller has more than 25 years' experience in quality management within the medical device industry. His areas of expertise include design control, corrective and preventive action (CAPA), product lifecycle, and change control.

At Regulatory Compliance Associates® Inc., Michael Miller is responsible for resource selection and deployment, program budget monitoring, and program risk management. He leads RCA's internal team in developing quality systems compliant to ISO 9001 and has worked with an outside consulting team to support RCA in obtaining ISO 9001 certification.

Additionally, he is recognized for solving complex product issues and developing strong relationships with customers, manufacturers, and suppliers.

Formerly at Baxter, Mike holds a Master of Business Administration from DePaul University in Chicago, Illinois, and a Bachelor of Science in Industrial Technology from Southern Illinois University. Mike lives in Lake Villa, Illinois, not far from the Wisconsin border.

General Manager

scoulter@rcainc.com

A business-focused leader heavily grounded in technology, Dr. Stephen Coulter has more than 30 years of proven success in leading product development organizations through commercialization with a focus on quality assurance and compliance excellence.

As Regulatory Compliance Associates® Inc.'s General Manager, his responsibilities include support of medical device and combination product companies in the areas of compliance with 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, and ISO 10993; remediation of legacy products; resolution of internal and external audit findings; lifecycle management / product support / sustaining engineering; and product development.

Dr. Stephen Coulter has areas of expertise in product development, design control, technology partnerships, product lifecycle management, and acquisition analysis. He is experienced in the development of manufacturing process controls and quality limits for critical product lines and has a global background in biomedical product, medical device, combination product, over-the-counter drug, consumer product, and environmental product companies ranging in size from startups to multi-billion dollar companies. He also successfully aligned development, quality, and compliance organizations within a company to establish and sustain regulatory compliance to United States and international medical device regulations.

Steve's regulatory affairs and quality assurance experience includes developing, strengthening, and auditing company design control, GMP, and quality systems; remediating design history files in response to internal and external reviews; providing technical input; and participating in company advocacy efforts with federal agencies, congressional personnel, and public health groups.

His fields of technical experience include polymer synthesis: urethanes, silicones, acrylics, rubbers (latex and synthetic), epoxies, and biodegradables. He also has experience with polymer processing including molding, latex dipping, extrusion, coatings, and composites. Other technical areas of expertise include surface modification methods for improved compatibility or processing, over-the-counter drugs, microbicides, and antibacterial treatments; natural products and herbal formulations for consumer products; and sensor development (e.g. critical care cardiac, consumer in vitro diagnostics, immunochemical, and environmental monitors).

Steve is a noted published author, exceptional presenter, and multiple patent holder who has established and participated in patent committees to manage intellectual property (e.g., invention disclosures, patent applications, and product registrations) and has executed and managed technology assessment activities including confidentiality and licensing agreements, due diligence efforts (technical, regulatory, and compliance) and technology partnership programs with entrepreneurs and academia.

Steve has a Ph.D. in Macromolecular Science and Engineering and Organic Chemistry and a Master of Science in Chemistry from the University of Michigan. He has received numerous awards and appointments. Steve is a Palm Desert, California resident.

Senior Director, Consulting Services

r.honaker@rcainc.com

Richard Honaker has served as a consultant for Regulatory Compliance Associates® Inc.'s manufacturing processes since 2013. His areas of expertise include CAPA, pharmaceuticals, GMP, medical devices, validation, quality systems, verification and validation, change control, and regulatory affairs.

Prior to RCA, Richard Honaker was with Hospira where he was responsible for all long-term financial planning and day-to-day operations for nine plants throughout North America, Latin America, and Europe totaling 8,000 employees. His product lines included parenteral products, IV sets, and plastic injection molded products. He was also responsible for global service and inventory, adherence to local regulatory agencies, as well as cross plant approvals for multiple product lines.

Rick has served as Vice President, U.S. Parenteral Operations for Abbott Laboratories, where his responsibilities included capital / budgeting approvals and inventory management, U.S. products service levels, diverse product lines, and succession planning and staffing.

Rick earned a Master of Business Administration in International Economics from Ashland University in Ohio and a Bachelor of Arts in Accounting from Walsh University in Ohio. Rick resides in Trevor, Wisconsin.

Director, Program Management

l.servi@rcainc.com

Larry Servi has 30+ years’ experience leading medical product development and engineering. His areas of expertise include project management, portfolio analysis and planning, design control, risk management, CAPA management and investigations, problem solving, and materials and process engineering.

At Regulatory Compliance Associates® Inc., Larry Servi provides consulting services to the pharmaceutical, biotechnology, and medical device industries. This includes leading assessments in various areas of quality systems and design control and devising and leading remediation programs. Larry also has provided his project management expertise to clients looking to outsource engineering or product development programs.

Prior to RCA, Larry was at Covidien, Baxter, and Parker Hannifin, where he initially specialized in polymer development and process engineering and then transitioned into medical device and combination product engineering. He has launched over a hundred new products and holds four United States patents.

Larry holds a Master of Science in Engineering Management and a Bachelor of Science in Chemical Engineering from Northwestern University. He received his PMI certification as a Project Management Professional in 2005. Larry lives in the Chicago suburb of Hawthorn Woods.

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