Debra Pagano

Debra L. Pagano is an independent consultant who operates her own company under an LLC in Pennsylvania. She has been a consultant to FDA regulated industry since 2002. In this capacity, she is a compliance consultant to the Pharmaceutical, Biologics and Medical Device Industries conducting mock pre-Approval and CGMP inspections of international and domestic firms. Coverage for CGMP inspections has included the systematic approach with a strong focus in the microbiological laboratory including the review of environmental monitoring programs for aseptic manufacturing and non-sterile manufacturing facilities. Projects have included GAP assessments for critical compliance issues and functions within the FDA regulated industry. She provides CGMP training and presentations on various FDA related topics domestically and internationally.

Debra previously worked for the Food and Drug Administration for 17 years. She was the Pre-Approval Program Manager from October 1994 to October 2002 and previously held positions as drug specialist and investigator. She was a course advisory member and teacher for FDA’s Pre-Approval Inspection Training Course for Investigators and Chemists; FDA’s Pre-Approval Manager Update session and FDA’s Basic Drug School. She is an adjunct professor for Temple University's Quality Assurance/Regulatory Affairs Masters Program. She has conducted numerous inspections in the pre-approval program and pharmaceutical areas and was on FDA's Foreign International cadre.