25 Harbor Drive., Suite101
Vernon Hills, IL, 60061
Practical Compliance Solutions
(847) – 549- 0626 ext.223
Dr. Capone has been actively involved in drugs,
medical devices, and biologics for thirty years. His work experience includes
the research, development and manufacture of same as well as extensive
management responsibility for microbiology, quality systems and regulatory
affairs. His fifteen years of independent consulting have involved him in the
strategic development of quality systems and product approval submissions.
Dr. Capone specializes in the development of all facets of the quality system
including test method and process validation for both domestic and international
manufacturers particularly in response to FDA actions.
Emphasis on the technical aspects of microbiology
and sterilization, design, and process validation along with analytical method
validations and characterizations including test methods, compendial methods,
and immunochemistry. Assists in the development of appropriate quality systems
as determined by audit or in response to a regulatory action. International in
scope and providing FDA quality systems and regulatory support from start-ups to
healthcare corporations with sales in excess of $ 7 Billion annually.
validation plans and validation master plans for all aspects of the device
pharmaceutical manufacturing operation.
Review, audit and
help prepare FDA submissions, i.e., NDA, aNDA, 510(k), PMA.
site-specific training for design controls, risk assessment, design of
experiments, executive level training to the Quality System Regulations [Parts
211 (Drugs) and 820 (Devices)]
for general laboratory and microbiological controls for the pharmaceutical and
device quality laboratory.
for method characterization, validation, and method transfer consistent with
compendial and non-compendial test methods.
and Verification protocol development and execution
protocol development and execution.
Dr. Capone received his B. A. in Biology from New York University
and his M.S. and PhD in microbiology from Florida State University. He did
post-graduate work in immunology at the University of Illinois. He has
extensively published in the areas of quality systems and regulatory