About Ms. boyce
During Ms. Boyce's Tenure at the FDA:
the following awards and programs were received:
FDA Commendable Service Awards (1990, 1991, 1992)
Nominated for FDA Investigator of the Year (1990)
Government Investigator of the Year (1990)
Ms. Boyce was one of onely two witnesses allowed to testify 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.
Selected for and completed FDA's National Mid-Level Training Program (1991-1992) during which many assignments were completed with the FDA's Commissioner's Office; Center for Device Evaluation's Program Operations Staff; Office of Device Evaluation, Center for Device and Radiological Health; Office of Compliance and Office of Drug Evaluatuion, Center for Drug Evaluation and Research; Acting Director of Compliance, FDA Kansas City District.
Ms. Boyce audited approximately 80 medical device manufacturers, contract sterilizers, laboratories, pharmaceutical manufacturers and IVD manufacturers. Ms. Boyce was involved with the post-inspection compliance strategy working with the Dallas District FDA as well as CDRH and FDA's Office of Chief Counsel (OCC).
90% of Ms. Boyce's FDA audits resulted in regulatory action, so now we can help tell you what the FDA is looking for. Also, with this experience, Ms. Boyce can help you solve any FDA action that you have incurred.
Also during her FDA tenure, Cheryl 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 investigation device exemptions and necessary corrective action.
Ms. Boyce developed a Medical Device Training Program for other FDA investigators and provided training to FDA investigators in the Dallas District FDA Office and the Kansas City District FDA Office.
Cheryl Boyce also performed various assignments with the FDA's Commissioner's Office; Program Operations staff in the 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.
Key Accomplishments with Industry:
Ms. 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 work.
Ms. Boyce has acted as an outside QSR expert for FDA which includes analysis of FDA QSR inspections, recommendations to FDA on inspection tactics and goals, assistance to FDA OCC attorneys and analysis of firm's corrective action plans. Development of detailed written depositions. One of these FDA Cases was Abbott Labs, which was one of FDA's largest medical device cases.
Acted as an Expert Witness for Medical Device Death Case Involving CVC Catheter deaths which included case review, written report and depositions.
Provided expert testimony to Grand Jury involving FDA regulatory, quality and criminal problems at an infusion pump manufacturer.
Provided QSR and process validation training to FDA Dallas District Office and Texas State Department of Health.
Successfully completed approximately 150 audits of medical device, sterilization and in-vitro diagnostic manufacturing facilities including recommended corrective actions.
Developed and implemented DFMEAs and PFMEAs for all product lines for 5 medical device companies.
Developed and established approximately 100 quality systems for the medical industry. Approximately half of these were for companies that had FDA-483's, and/or warning letters, or were under Consent Decrees with FDA. Ms. Boyce has also helped a company under a DOJ investigation to properly develop their CAPA and Risk Management Programs, DFMEAs and PFMEAs. I have responded to approximately 30 FDA-483's and Warning Letters for industry, all resulting in acceptable results from FDA.
Provide GMP and process validation training classes to the medical device industry.
Contributor and Co-author to the ASQ Quality Audit Handbook 1/97.
Selected as a trainer for the AAMI QSR (new medical device Quality System Regulation) national training sessions.
Successfully designed, developed, and helped manage a global quality system improvement master plan for a multinational pharmaceutical/medical device manufacturer which encompassed multiple sites in both the U.S. and Europe. Resulted in improved FDA compliance status and quality systems.
Successfully developed, implemented and helped manage a Good Laboratory Practices Program (GLP) for a Texas State University. This included the development of all required documents and provided management and personnel training. Program resulted in successful obtainment of new GLP studies and compliance with FDA regulations.
Successfully developed, implemented and helped manage an annual product review (APR) program for 49 different pharmaceutical sterile products for a multinational pharmaceutical and medical device manufacturer which encompassed multiple sites. Resulted in improved FDA compliance status, quality systems and APR system.
Publications:
Cheryl 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.
C. Boyce - Contributor to the ASQC Quality Audit Handbook 1/97
C. Boyce - Contributing author to the AAMI QS Regulation Training Manual being used to train industry and FDA on the QS Regulation. She was also selected as a trainer for the AAMI QSR (new medical device Quality System Regulation) national training sessions.
Woods, TS and Boyce, CA: Improving Process Quality Through Variation Research (Part 1). Medical Device and Diagnostic Industry Vol 14 No. 7: 66-68, July, 1992.
Woods, TS and Boyce, CA: Improving Process Quality Through Variation Research (Part 2). Medical Device and Diagnostic Industry Vol 14 No. 7: 66-68, July, 1992.
C. Boyce - Contributor and Author of The Quality System Compendium GMP Requirements & Industry Practice. Association for the Advancement of medical instrumentation 1996.
C. Boyce - Contributor to The Quality Audit Handbook. American Society for Quality Control Audit Division 1997.
Co-Author: Proposed Validation Standard VS-1 Nonaseptic Pharmaceutical Processes, The Journal of Validation Technology, February 2000, Volume 6 Number 2.
Professional Certifications:
Certified Regulatory Affairs Professional – 12/10;
ASQ Certified Quality Auditor - 6/08;
RAB Certified Quality Management System Lead Auditor (#Q02450) - (Experience Codes 11 & 17) 2/11;
Member of Cambridge Who’s Who