Larry offers a background that few, if any, other consultants can offer. He's an FDA expert who also is a seasoned business professional and routine expert witness.
Larry started with FDA in 1972 and worked for them for 10 years. In 1982 he entered the medical device industry in the role of a Manager of Regulatory Affairs. He rose through the ranks in the industry eventually becoming a VP of RA/QA/Clinical for several large and small cardiovascular companies.
He returned to FDA in November of 2000 and finished his career with the agency in September 2011—rejoining the consulting world.
His specialties include: planning, creating, and auditing quality systems. Creating clinical plans including protocol development, case report form development, and implementing and managing clinical trials; design control to meet FDA requirements. He is a professional speaker who can train persons on all aspects of FDA requirements and practical and successful solutions to FDA problems. He regularly serves as an expert witness in cases involving FDA requirements for medical devices.
Gary is an internationally recognized expert in multivariate spectroscopic analysis, pharmaceutical analysis, regulatory compliance, laboratory management, design quality, and process analytical technology using spectroscopic methods including near-infrared, Raman and multivariate analysis. Gary has nineteen years of industry experience with increasing responsibility, five years of policy experience and ongoing consulting experience in the pharmaceutical and biopharmaceutical industry.
As a USP in-house expert on the FDA Process Analytical Technology and Quality by Design Initiative, he was responsible for over thirty Pharmacopeial chapter revisions that incorporated and reflected the revisions by the FDA on the 21st Century CGMP Initiatives. He also led collaborations on several FDA, USP and industry projects that resulted in several Pharmacopeial standards. Gary has more than twenty-five peer reviewed papers and book chapter contributions; four issued patents, numerous industry journal articles and has been invited to give many conference and symposia presentations worldwide.
Corrine has over twenty five years of accomplished regulatory, quality assurance, and clinical affairs experience with FDA and ISO regulatory requirements, including quality systems, regulatory submissions, CE marking and clinical trial development. She has assisted medical device manufacturers with regulatory strategies and the submission of IDE’s, 510(k)’s, and PMAs as well as the implementation of compliant quality systems including correcting deficiencies found during FDA, state or notified body inspections, auditing, and training.
Corrine specializes in creating and implementing compliant quality systems for 21 CFR 820 and ISO 13485:2003 for medical device companies; full quality system audits; quality system training in both seminar and small group formats; and labeling and promotional material review.
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Devin helps companies get their products to market without regulatory delays and high costs. He helps quality, development, and manufacturing work together by providing strategies to work through regulations. He provides solutions when faced with the need to manage cultural change across the organization and in relations to your partners, suppliers, and CMOs.
He has experience leading product development teams involved with third-party design and build of electromechanical subsystems as well as their interaction with software technologies. He brings 28 years of product development experience coupled with accomplishments in research and development, quality, regulatory and manufacturing.
He has experience working to align quality management systems including risk management and validation testing methods and procedures between worldwide facilities, customers, and third party vendors. He also has experience aligning requirements management activities with product specifications through hands on interaction with R&D and manufacturing. Devin's specialties include Six Sigma black belt, Lean Manufacturing, Finite Element Analysis, Project Management, Blue Ocean Strategy, and FDA Validations.
Rich is a seasoned executive who takes a pragmatic approach to quality management, regulatory affairs, and compliance to achieve cost effective and successful outcomes.
His experience spans world-class enterprises and multinational organizations in medical device industries as a hands-on Quality Engineer, R&D Manager, QA Plant Manager, Director QA/RA, and Vice President QA/ RA. This range of experience enables him to quickly target pragmatic solutions to difficult problems.
Rich has also spent significant time preparing for and hosting regulatory audits and remediating difficult audit observations. He has designed and implemented Design Control, Software Validation, CAPA and other quality system elements that have stood up to robust examination by both Notified Bodies and FDA inspectors.