CONSULTANT QUALIFICATIONS:
CV, RÉSUMÉ, BIOGRAPHY,
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Dr. T. C. Soli, Principal Consultant and President of Soli Pharma Solutions, Inc. (SPS), has acquired considerable knowledge of pharmaceutical water systems through his 25 years of involvement with 5 pharmaceutical operating companies and career-long memberships on numerous industry-wide working committees related to water, including his current participation in the USP Pharmaceutical Water Expert Committee.
His expertise also extends into all aspects of sterilization, aseptic and contamination control processes and the disciplines related to their quality control and testing, validation, and regulatory compliance. During his career with operating companies, he has managed personnel and processes in various departments including microbiology and chemistry development laboratories, QC laboratories, regulatory affairs, project management, business development, and QA departments ranging from validation to complaint investigation.
Using vacation time from his operating company jobs, Dr. Soli has been consulting part-time since 1995 for small and large pharmaceutical companies and related instrument manufacturers, and has served as an expert witness in two litigations. He has also conducted numerous informational and training sessions related to pharmaceutical water microbiology and chemistry and written numerous articles and USP chapters, including the famous USP Informational Chapter <1231> Water for Pharmaceutical Purposes. His consulting endeavors are now full time with SPS. This broad range of experience, his formal microbiology education, his innate problem solving skills, and his personality prepare him to be a skilled consultant and of great utility to FDA regulated industries, especially pharmaceuticals, biologicals, and medical devices.
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