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James J. Capone, Ph.D.

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.

         Develop master 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.

         Develop 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)]

         Develop procedures for general laboratory and microbiological controls for the pharmaceutical and device quality laboratory.

         Develop procedures for method characterization, validation, and method transfer consistent with compendial and non-compendial test methods.

         Design Validation and Verification protocol development and execution

         Process validation 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 affairs.


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