Sean W. Hilscher Pharmaceutical Credentials
About Us
Sean holds a B.S. in Microbiology from the University of Georgia and maintains professional affiliations with the Parenteral Drug Association and the Regulatory Affairs Professionals Society. His credentials include FDA Level II Certification in Medical Devices and comprehensive FDA training. Sean’s technical acumen, regulatory expertise, and leadership experience make him a pivotal resource for companies navigating complex compliance landscapes.
Throughout his career, Sean has held leadership roles at Strategic Compliance Services, Kimberly-Clark Healthcare, and Baxter Healthcare Corporation. As President of Strategic Compliance Services, he has guided clients in developing regulatory strategies, quality systems, and corrective action plans. At Kimberly-Clark, he established compliance programs and audit systems to enhance manufacturing quality globally. His tenure at Baxter included oversight of 205 facilities across six continents, driving compliance improvements, and managing integration programs for acquisitions. Sean's career began with the FDA, where he conducted over 100 inspections, authored warning letters, and provided technical expertise as a software validation specialist.
Other Expertise
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Expertise in terminal sterilization and aseptic processing.
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Proficient in manufacturing APIs, including chemically and biotechnologically derived substances.
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Skilled in managing combination products, extended-release solid oral dosages, and radiopharmaceuticals.
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In-depth knowledge of computerized systems such as LIMS and SCADA, adhering to cGMP requirements.
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Experienced in developing effective CAPA systems for quality management.
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Proficient in complaint handling and regulatory gap analysis.
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Adept at ensuring compliance with FDA and international regulatory standards.
Our Clients
