General Manager

scoulter@rcainc.com

A business-focused leader heavily grounded in technology, Dr. Steve 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.

Steve's areas of expertise include 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

Rick 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, Rick 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, Quality Systems

r.davis@rcainc.com

With more than 30 years as a medical device professional, Rick Davis' broad expertise includes quality management systems, engineering, document control, manufacturing, and regulatory compliance from validation through Six Sigma.

He is also highly experienced in design and process validation, product reliability, quality audits, design and development processes, risk management, project management, lean / value engineering, and continuous improvement.

At Regulatory Compliance Associates® Inc., he provides consulting services in the areas of quality management systems, engineering, and regulatory compliance for its medical device clients.

Rick's extensive product experience includes a patent for a blood pressure device as well as dialysis equipment, refractive surgical lasers, ophthalmic instruments, sterile tubing sets and sharps, surgical lasers, non-invasive patient monitors, pacemakers, and pacemaker leads.

Prior to RCA, Rick served as Senior Quality Manger with Baxter where he managed quality engineering and quality systems staffs for the Renal Division’s instrument design center. He was responsible for assuring the effective implementation of the quality system for the facility in accord with FDA Quality System Regulation and ISO 13485. He also provided quality engineering personnel, development team members, and support for the facility's product development and product life cycle management of hemodialysis and peritoneal dialysis instruments.

Rick is a member of the American Society of Quality Control Biomedical Division, ASQ Section 1508, and International Society for Optical Engineering.

He earned a Bachelor of Science in Electrical Engineering from the University of Florida in Gainesville. Rick resides in Palm Harbor, Florida.

Director, Validation Program Management

b.mccrea@rcainc.com

Brendan has more than 27 years' experience in life science product development, manufacturing and compliance. He oversees the validation programs at Regulatory Compliance Associates® Inc. and is our resident expert in facility and critical utility design. He has significant experience in U.S. and international greenfield and remediation projects for medical device, pharmaceutical, and biological products.

Other areas of expertise include process validation and quality system development, remediation, regulatory affairs, and engineering management. He is a lead internal expert on design controls, FDA inspectional readiness, warning letter remediation, and CAPA systems. He has extensive industry expertise in drug and biologics development and commercialization.

Prior to RCA, Brendan held roles at other leading firms including C.R. Bard, Roache, GE, IMPRA, and Lumned. Clients include Abbot, Edwards, Baxter, Telflex, Takeda, Roache, and others.

A holder of eight patents, Brendan graduated with a Bachelor of Science in Mechanical Engineering from the University of Massachusetts. He lives in Manchester, Missouri.

Director, Program Management

l.servi@rcainc.com

Larry 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 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.

Director, Regulatory Affairs

l.biava@rcainc.com

Linda Biava is a proven regulatory and project manager recognized for her decisive leadership, expertise in reducing costs and project times, and meeting timelines in FDA-regulated environments. Her background includes comprehensive laboratory, R&D, and product development; successful regulatory strategy and submission preparation; FDA inspection and 483 / Warning Letter remediation; as well as project management and supervisory experience in the pharmaceutical industry. She is also known as a strategic thinker with strong analytical, problem solving, and collaborative skills.

As a Director of Regulatory Affairs, her responsibilities at Regulatory Compliance Associates® Inc. include evaluating and preparing global regulatory strategies and providing the required inputs for marketed drug products and generic drug programs. She serves as a Regulatory Affairs subject matter expert and provides input for successful development, filing, approval, implementation, and remediation work associated with projects. Additionally, her strengths include project management, corrective action, new technology, quality assurance, and streamlined processing initiatives.

Linda's expertise extends to international registration support in Canada, EU, Asia, Pacific Countries, and Australia; FDA inspection readiness support; quality systems / regulatory application gap analysis or due diligence; and streamlining manufacturing, laboratory, and compliance processing and laboratory analysis support.

Prior to joining RCA, Linda served as a Senior Regulatory Affairs executive with Hospira, Inc. Her work has been published in FDANews and Omni Publications.

Linda is certified by the Regulatory Affairs Professional Society (RAPS) and earned a Bachelor of Science in Biology from the University of Kansas.

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