Deborah McHugh

Fagron North America
Vice President Quality North America
Deborah has a Biochemistry degree from Wheaton College and Masters Certificate of Public Health from Harvard School of Public Health. She has spent 30 years in Quality – starting in Diagnostics, then moving into the Biotech industry, supporting commercial production as well as pre-approval readiness and inspections for new products; and most recently, has spent the past 8 years in the 503B Outsourcing Facility industry.

Deb had previously been a Quality Site Head for an Outsourcing facility, managing the Quality Assurance, Quality Control, and Training areas as well as various Regulatory aspects. This year, she has transitioned into a Regional role, overseeing all sites/businesses at Fagron. Deb participates on the FDA’s Cross-Sector Stakeholder Group for the Compounding industry and is part of ISPE’s Steering Committee for the Compounding Communities of Practice.

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Visual Inspection Is Key to Ensuring Patient Safety in US Pharmaceutical Compounded Products
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Visual Inspection Is Key to Ensuring Patient Safety in US Pharmaceutical Compounded Products

Visual inspection is nothing new to professionals who make, prescribe, prepare, and/or administer pharmaceutical parenteral products to patients of all backgrounds, especially those who may have immunity concerns. The pharmaceutical industry has tried to ensure that companies enact the best quality standards that are consistent with Current Good Manufacturing Practices (CGMPs) to prevent an...