Patricia Gupta Patti Gupta and Associates

Patti Gupta spent 11 years in FDA as an investigator and supervisor, specializing in pharmaceutical manufacturing. She left FDA in 1999 and joined Merck & Co. where she became Director of Worldwide Quality Assurance, responsible for the corporate internal audit program for all of Merck's sites globally. She left Merck to join Genentech, Inc. in 2002 as Director / Senior Director of GMP Compliance where she was again responsible for the company's internal audit and compliance programs. Patti later joined Janssen Pharmaceuticals as Vice President of Compliance, responsible for the company's internal audits, product recalls and overall compliance program for the company's 32 plants worldwide. She currently serves as President and Principal Consultant at Patti Gupta & Associates LLC.  As such, she has consulted for many of the world’s largest and most innovative pharmaceutical and biotech companies.  She has expertise in preparing for Pre-Approval Inspections, benchmarking and facility assessments and general GMP compliance questions and issues including responding to FDA-483's or Warning Letters.  Patti has her Bachelor’s Degree in Medical Microbiology from the University of Wisconsin – Madison.