Boyce Consulting
“Our
primary goal is to help you become self-sufficient, saving both time and
money.”
Boyce Consulting provides
personalized, cost-effective FDA regulatory and quality solutions and training
to both small and large companies and entrepreneurs. Boyce associates have 83
years of combined experience providing "concept-to-implementation"
services. We are known for strategic compliance, regulatory and systemic
corrective action planning/development which provides realistic solutions to
meet both the client's business and regulatory obligations. We provide and
implement recommendations for improving and streamlining current quality
systems to obtain cost-savings using appropriate statistical techniques.
Services
Available
·
Gap Analyses;
·
Audits for Due Diligence;
·
Process HACCP & FMECA review, development, and execution;
·
Company and/or Facility-Wide Improvement Action Plans;
·
Product and process design control plans and programs;
·
Process validation and optimization using applicable
statistical techniques;
·
Personnel training;
·
Preventive action program development and execution, review
and/or training;
·
Cost of quality evaluations;
·
Internal auditing program development and execution;
·
Evaluation for streamlining/improving current quality
systems;
·
Appropriate premarket submission format and contents;
·
Management Reviews with Measurement Matrices;
·
Using customized troubleshooting software to diagnose and
solve quality problems.
Our
Expertise
Boyce associates are accredited to perform
quality management system certification to ISO-9000 via an economical
project-rate basis. We also have customized troubleshooting software which can
help you diagnose and solve quality problems. Boyce Consulting affiliates can
readily design and supply clean rooms, environmentally-controlled rooms and all
ancillary equipment. We frequently work with FDA as an outside GMP expert
witness and are involved with FDA/Industry coalitions, workshops and alliances.
We have provided GMP and process validation training to FDA and the Texas State
Department of Health. Our involvement insures that your company has the most
up-to-date information on "real world" current FDA strategies and
policies. We work at the cutting edge of technology and with the latest in
quality/regulatory issues so that we may better serve our clients.
Our Team
Our staff and associates have 83 years worth of industry
experience and includes a chemical engineer, a microbiologist, engineering
statistical expert, and biology graduate. C. Boyce, President and Chemical
Engineer, is the former FDA Southwest Regional Medical Device Specialist and is
an RAB Certified Quality Systems Lead Auditor, an ASQ Certified Quality Auditor,
and Regulatory Affairs Certified Professional.
Certificates
& Awards
C. Boyce has 15 years of experience both with FDA and as a
consultant which has included contract employment in the pharmaceutical and
device 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).
Prior
Experience
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.
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