Boyce Associates
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of Boyce Consulting
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cab@boyceconsulting.com
Boyce Consulting, Inc. has performed 150 QSR, GLP and GCP audits and has helped 125 small and large companies, and entrepreneurs comply with FDA regulations, project planning, systemic corrective actions, product approvals, FDA strategic planning, due diligence audits, labeling reviews, process and test method validations, development and execution of quality systems, export status evaluations, OTC drug monograph analysis.
C. Boyce has 25 years of experience both with FDA and as a consultant which has included contract employment in the medical device, IVD and pharmaceutical industries. During Boyce's FDA tenure the following awards and programs were received:
- FDA Commendable Service Award (1990, 1991, 1992).
- Nominated for FDA Investigator of the Year (1990).
- Government Investigator of the Year (1990).
- Selected for and completed FDA's National Mid-Level Training Program (1991-1992) during which time many assignments with the FDA's Commissioner's Office; Center for Device Evaluation's Program Operations Staff; Office of Device Evaluation, Center for Devices and Radiological Health; Office of Compliance and Office of Drug Evaluation, Center for Drug Evaluation and Research; Acting Director of Compliance, FDA Kansas City District (1990).
Also during the FDA tenure, C. Boyce provided expert technical assistance to FDA's Office of the Commissioner, Special Assistant for Investigations, regarding the scientific and regulatory quality of 510(k) premarket notifications and investigational device exemptions. Provided written and verbal recommendations to the commissioner and the commissioner's investigation staff regarding the quality of 510(k)s and investigational device exemptions and necessary corrective action.
C. Boyce also performed various assignments with the FDA's Commissioner's Office; Program Operations Staff, Office of Device Evaluation, Center for Devices and Radiological Health; Office of Compliance and Office of Drug Evaluation in the Center for Drug Evaluation and Research; and Acting Director of Compliance, FDA Kansas City District (1990).
C. Boyce testified in U.S. District Court as FDA's Southwest Regional Medical Device Specialist. The court ruled with FDA. This trial is considered one of FDA's primary medical device GMP precedent-setting cases.
C. Boyce was appointed Special Master to the United States District Court of New Jersey as a regulatory and quality expert to determine the state of GMP and regulatory compliance of a medical device manufacturer for a District Court Judge. Advised judge on the GMP, quality, and technical state of the firm and provided recommended action. Continued to work for the judge based on his high compliments of my work.
C. Boyce leads the company’s team and specializes in strategic systemic corrective action planning for any quality and/or regulatory problem(s), actual implementation of all processes and training of client employees so the client becomes self-sufficient.
C. Boyce has published several articles and training manuals and contributed to several books including The Quality System Compendium, published by the Association for the Advancement of Medical Instrumentation.
Our microbiologist/ MBA has 30 years of medical device industry experience with several major medical device companies in several roles including production manager, R&D Liaison and quality microbiologist. He has helped many international and U.S. based companies prepare and train for FDA audits; and, is an expert during FDA audits and helps with post-audit recommendations, corrective actions, and responses.
Our mechanical and quality engineer has 15 years of experience in process and test method validation and QSR compliance. He is a process, product and sterilization validation expert including process development, requirements documentation, protocol development, test method development, test execution, and all associated documentation. He is also an expert at Risk Management and all tools and knowledge to develop all aspects of the Risk Management Program.
Our electrical engineer has 35 years of international and domestic industry experience as a Manufacturing Engineer, Senior Quality Engineer, Production Planner, and has been in charge of several major start-ups for industry. He has also been the Sr. Director of Quality and Regulatory Affairs at a major medical device company and is an expert at all types of risk analyses to help support a risk-based quality system and quality auditing.
Our 510(k), IDE and PMA expert has 22 years of experience with FDA and industry. She is an expert member of the ISO working group for mechanical cardiac assist devices (ISO/TC 150/SC 6).
Reviews and critiques regulatory pre-market submissions; reviews and develops clinical protocols; develops regulatory strategies for pre-market submissions; develops plans for IDE, 510(k), and PMA projects; assists in preparing pre-submission information and pre-submission interactions with FDA; assists in preparing design control documentation; assist with preparing responses to ODE deficiency letters; assist in preparing IDE requests for issues such as study expansion and labeling changes; review and provide pre-clinical engineering guidance; provide guidance regarding pre- and post-market adverse event reporting requirements.
Our additional electrical engineer has 22 years of experience in software and PLC validation work including developing and implementing all applicable protocols. He has trained numerous personnel on software and PLC validations and performed numerous process and design FMEAs as well as participated in engineering design reviews and developed and implemented all design and development procedures and phases.