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ROSS A. CAPUTO, Ph.D. CEO

Summary of Qualifications


Over 26 years management experience in the regulated healthcare industry in both international and domestic markets. General management experience has included management of new technologies, finance, engineering, materials, systems, quality control, product development, manufacturing, regulatory affairs and extensive peer relationships with field sales and customers. Graduate microbiologist. Recognized technical expertise in pharmaceutical microbiology with over 35 publications and presentations in the field of microbiology, biological indicators and sterility validation. He is active in PDA, ANSI/AAMI and ISO technical standards activities for the pharmaceutical and medical device industries. Participated in several NDA, ANDA, BLA and 510K submissions. Has audited several facilities for compliance against state and federal regulations.

Professional Experience


CEO, Pharmaceutical Systems, Inc. 1988 - Present
Founder and Chief Executive Officer of the company providing strategic and operations planning for start-up and Fortune 100 companies in the healthcare industry. The major focus of the company is providing expertise in FDA/cGMP operations management and new product development, as well as quality control, sterilization validation, including isolator and barrier systems, contract laboratory and research & development services to the pharmaceutical and medical device industries.

Provides consulting services to the pharmaceutical, biotechnology and medical device industries in the areas of microbiology, environmental monitoring, sterility assurance, vaccine production, Quality systems, regulatory and compliance issues including consent decree management, aseptic processing including barrier isolator systems and strategic operations planning.

Professional Experience


CEO, Pharmacy Support, Inc. February 2005 - Present
Founder and Chief Executive Officer of Pharmacy Support, Inc. (also known as PSI) founded in February 2005 as a wholly owned subsidiary of Pharmaceutical Systems, Inc. that focuses on issues facing pharmacists in the practice of compounding sterile and non-sterile preparations. PSI currently works with many compounding facilities to audit, assess, and develop action plans to facilitate compliance with USP chapters <797> and <795> and their associated references.

Pharmacy Support, Inc. assists with training needs for pharmacies on topics such as facility design, good documentation practices, process media fills, environmental monitoring, aseptic techniques, sterilization, training and final preparations testing. In support to the consulting activities of Pharmacy Support, Inc., PSI also offers laboratory testing needed for sterility testing, endotoxin and potency of finished preparation testing. Pharmacy Support Inc., offers free training to State Boards of Pharmacy around the country, recently visited states include: Utah, Kansas, and Arkansas, Massachusetts, and North Carolina, and upcoming scheduled is Colorado.

DIRECTOR, PHARMACY SERVICES/TRC, Baxter Healthcare Corp. 1977-1988

Assumed dual responsibilities in 1987 as Director, Pharmacy Services and Director, Travenol Regional Compounding. Direct reports included department heads of Manufacturing, Materials Management, Systems, Engineering, Quality, Distribution, Finance and Regional Compound Operations. Responsibilities included the start-up of a national pharmacy service business, the construction of 5 Pharmacies and 7 Service Centers in 13 states, staffing, sales/marketing strategy development and presentation to national accounts. The Pharmacy Business consisted of premixed chemotherapy drug solutions delivered to physician offices, managing the inventory and the hazardous waste generated. Combined annual sales of both units were $100 million with organizations totaling 110.

DIRECTOR, TRAVENOL REGIONAL COMPOUNDING (TRC), Baxter Healthcare Corp.

DIRECTOR, QUALITY ASSURANCE, Baxter Healthcare Corp.

DIRECTOR, RESEARCH & DEVELOPMENT, Baxter Healthcare Corp.

ASSOCIATE DIRECTOR OF MICROBIOLOGY, CORPORATE MICROBIOLOGY, Baxter Healthcare Corp.

MANAGER, STERILIZATION MICROBIOLOGY, Baxter Healthcare Corp.

SENIOR SCIENTIST, MICROBIOLOGY DEPARTMENT, AMSCO (American Sterilization Co.)

Education


Publications


  1. Caputo, R., A. Huffman, and R.R. Reich, 2005, “Practical Solutions for Microbiology, Sterility and Pyrogen Testing” in International Journal of Pharmaceutical Compounding, Vol. 9, No.1.  January/February 2005.  Pp 9-12.
  2. Reich, R.R. and R. Caputo, 2004.  “Vapor Phase Hydrogen Peroxide Resistance of Environmental Isolates” in Pharmaceutical Technology, August 2004.
  3. M. Jeffrey, J. Koeller, J. Zdunek, R. Byrne, and R.A. Caputo,
    Validation of an Enhanced Method of Bacterial Ribotyping for Improved Efficiency and Identification of Stressed Isolates.  Pharm. Technol. 28 (3), 156-165 (2004).
  4. D. Khorzad, A. Khorzad, J. Herche, R.R. Reich and R.A. Caputo,
    Design and Operational Qualification of a Vapor-Phase Hydrogen Peroxide Biological Indicator Evaluator Resistometer (BIER) Unit.  Pharm. Technol. 27 (11), 84-90 (2003).
  5. R.A. Caputo
    Validation Testing of a Gas Plasma Sterilization System.  Medical Device & Diagnostic Industry, January 1993.
  6. R.A. Caputo
    Alternative Sterilization Technologies Come of Age, Gas Plasma Section.  Medical Device & Diagnostic Industry, December 1992.
  7. R.A. Caputo
    AbTox Plazlyte Plasma Sterilization.  Journal of Healthcare Material Management, September 1992.
  8. R.A. Caputo
    Biological Monitoring:  Is your practice valid as well as cost effective?  In 3M Healthcare Quarterly Newsletter, Infection Control Rounds, February 1991.
  9. R.A. Caputo and T.E. Odlaug
    Sterilization with Ethylene Oxide and Other Gases.  In Disinfection, Sterilization and Preservation.  Ed. Seymor S. Block. Third Edition, Chapter 2, 1983.
  10. T.E. Odlaug, V. Jarzynski, R.A. Caputo and C.C. Mascoli
    Evaluation of an Automated System for Rapid Identification of Bacillus Biological Indicators and Other Bacillus Species.  Journal of Parenteral Science and Technology, March/April 1982.
  11. R.A. Caputo, K.J. Rohn and C.C. Mascoli
    Biological Validation of an Ethylene Oxide Sterilization Process.  Developments in Industrial Microbiology.  Vol. 22, 1981.
  12. T.E. Odlaug, R.A. Caputo and G.S. Graham
    Heat Resistance and Population Stability of Lyophilized Bacillus subtilis Spores.  Applied and Environmental Microbiology, Vol. 41, 1981.
  13. G.S. Graham, T.E. Odlaug, R.S. Schwabe and R.A. Caputo
    Effect of Growth Conditions on Sporulation and Heat Resistance of Bacillus stearothermophilus Spores.  ASM Abstract, National Meeting, March 1981.
  14. K.J. Rohn, D.L. Stryker and R.A. Caputo
    Ethylene Oxide Resistance and Population Stability of Bacillus subtilis var. niger (globigii) Spores on Various Carrier Materials.  ASM Abstract, National Meeting, March 1981.
  15. T.E. Odlaug, R.A. Caputo and G.S. Graham
    Heat Resistance and Population Stability of Lyophilized Bacillus subtilis Spores.  ASM Abstract National Meeting, March 1981.
  16. R.A. Caputo and C.C. Mascoli
    Design and Use of Biological Indicators for Sterilization Cycle Validation.  Medical Device and Diagnostic Industry, August 1980.
  17. R.A. Caputo, K.J. Rohn and C.C. Mascoli
    Biological Validation of an Ethylene Oxide Sterilization Process.  Society for Industrial Microbiology National Meeting August 1980.  Developments in Industrial Microbiology, 1981.
  18. T.E. Odlaug, R.A. Caputo and C.C. Mascoli
    Determination of Sterilization Values by Microbiological Methods.  Society for Industrial Microbiology National Meeting, August 1980.  Developments in Industrial Microbiology, 1981.
  19. R.A. Caputo, T.E. Odlaug and C.C. Mascoli
    The Effect of Heat Shock Treatment on the D and Z Value of Bacillus Spores.  ASM Abstract National Meeting, May 1980.
  20. R.A. Caputo, K.J. Rohn and C.C. Mascoli
    Recovery of Biological Indicator Organisms After Sublethal Sterilization Treatment.  Journal of Parenteral Drug Association, July/August 1980.
  21. R.A. Caputo
    Design and Use of Biological Indicators for Sterilization Cycle Validation.  Proceedings of PMA Seminar on Biological Indicators, February 25-27, 1980.
  22. R.A. Caputo, T.E. Odlaug; R.L. Wilkinson and C.C. Mascoli
    Biological Validation of a Steam Sterilized Product by the Fractional Exposure Method.  Journal of the Parenteral Drug Association, Vol. 33, 4 July/August, 1979.
  23. K.J. Rohn and R.A. Caputo
    Post Sterilization Stability of Ethylene Oxide Biological Indicators (B. subtilis var. niger). ASM Abstract, National Meeting, May 1979.
  24. R.A. Caputo, T.E. Odlaug, R.L. Wilkinson and C.C. Mascoli
    Biological Validation of a Sterilization Process for a Parenteral Product-Fractional Exposure Approach.  ASM Abstract, National Meeting, May 1979.
  25. K.J. Rohn and R.A. Caputo
    Post Sterilization Stability of Ethylene Oxide Biological Indicators (B. subtilis var. niger).  ASM Abstract, National Meeting, May 1979.
  26. R.A. Caputo, T.E. Odlaug, R.L. Wilkinson and C.C. Mascoli
    Biological Validation of a Sterilization Process for a Parenteral Product-Fractional Exposure Approach.  ASM Abstract, National Meeting, May 1979.
  27. R.L. Wilkinson and R.A. Caputo
    Heat Resistance of Bacillus subtilis 5230 Spores in Parenteral Solutions-Determination of a Model Substrate for the Biological Validation of Sterilization Processes.  ASM Abstract, National Meeting, May 1979.
  28. D.P. Brunner, R.A. Caputo, G.S. Graham and R.W. Treick
    Functional Reconstitution of Biological Properties of the Outer Membrane of Gram-Negative Bacteria (Endotoxin).  Journal of Bacteriology, November 1978.
  29. R.A. Caputo
    Biovalidation of Sterilization Processes.  Proceedings of the PMA Seminar Program on Validation of Sterile Manufacturing Processes.  March 15-16, 1978.
  30. D.D. Barnhart, R.A. Caputo and T.M. Petro
    Primary Antigen Binding:  Comparison of Minibeaker Rapid Dialysis. Equilibrium Dialysis and Ammonium Sulfate Precipitation.  Journal of Immunological Methods, 1978.
  31. D.P. Brunner, R.A. Caputo and R.W. Treick
    Functional Reconstitution of EDTA-Treated Escherichia Coli.  Biochemical and Biophysical Research Communications, February 1977.
  32. R.A. Caputo, D.D. Barnhart and R.W. Treick
    A Rapid Measure of Primary Antigen Binding Capacity of Antiserum.  Microchemical Journal 21, 85-91, 1976.
  33. R.A. Caputo, R.W. Treick, C.C. Griffin and M.P. Farrel
    Rapid Determination of Cetylpyridnium Chloride Bound by Bacteria.  Applied Microbiology 29, 4776-479, 1975.
  34. Doctoral Dissertation:  Physio-Chemical Properties and Functional Role of EDTA Released Material of Mutants of Escherichia Coli K-12.  Page 678, Miami University, Oxford, Ohio, 1976.
  35. Master Thesis:  The Sensitivity of Escherichia Coli K-12, p. 678 Mutants to Several Commercially Utilized Antimicrobial Compounds.  Miami University, Oxford, Ohio, 1974.

Presentations


Ross Caputo personal website. Ross Caputo is a fan of the Milwaukee Brewers and Green Bay Packers. Ross Caputo does not always follow the New England Patriots, Texans or Redskins but does love the Houston Astros. Ross Caputo plans on celebrating boss day 2018, also known as Boss's Day. Ross Caputo follows 60 minutes and the Dow Jones news. Ross Caputo does not listen to Lady Gaga, but has nothing against those that do like her music. Ross Caputo follows the NYSE also known as the New York Stock Exchange. Did you know Ariana Grande broke up with Pete Davidson?