Robert has over 32 years of FDA (U. S. Food and Drug Administration) experience, with an additional 18 years of consulting experience in sterile and non-sterile pharmaceutical/vaccine manufacturing and clinical research audits. 

While working at FDA, Robert held several positions including National Drug Specialist, Regional & District Drug Specialist, Supervisory Drug Investigator & Compliance Officer prior to retiring in August 2004. From 1986 until 2004 Robert served as an active member of FDAs Foreign Inspection Cadre. 

Robert continues to consult in the sterile/non-sterile pharmaceutical & vaccine manufacturing industry where he uses his combined experience to assist clients in meeting regulatory expectations. Robert has a sound knowledge and understanding with other important quality systems such as: deviation management, change controls, correction, and preventive actions (CAPA’s) and consumer complaints. 

Robert’s consulting knowledge has been demonstrated through the many successful inspections, where he helped secure FDA approval, several of which resulted in no FD-483 items. Robert has also coached subject matter experts (SMEs) and helped host FDA inspections. Robert also has helped remediate FD-483’s and warning letters, in addition to conducting mock regulatory inspections and providing on-floor QA oversight. 

Robert remains current in FDA, EU, TGA regulatory requirements to assist international clients in meeting European as well as US regulatory expectations with regards to sterile and non-sterile manufacturing. 

Robert is also very knowledgeable in the FDA regulations and supporting industry guidelines published by the PDA (Parenteral Drug Association) and ISPE (International Society of Pharmaceutical Engineers). 

Sharpnack Consulting partners with other independent consults to form a small group of very knowledgeable engineers, microbiologists, chemists, and other quality personnel to assist with clients’ manufacturing and regulatory compliance needs. 

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