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Maxine Fritz has 25+ years of combined FDA, industry and consulting expertise and is responsible for overseeing the Pharma Biotech practice at NSF Health Sciences, serving in both a technical and management role. Ms. Fritz works with clients in the pharmaceutical, biologics, biotech and medical device industries to develop quality assurance, manufacturing and regulatory strategies for compliance with FDA regulations. She conducts and oversees regulatory gap analyses, assists with the development and implementation of quality systems, and develops and implements corrective action plans to address deficiencies identified by regulatory agencies. Ms. Fritz has successfully managed, resolved and consulted on large complex compliance projects including corporate warning letters, mass seizure, consent decree(s), Application Integrity Policy (AIP) prosecution and import detentions.
Ms. Fritz is a former U. S. Food and Drug Administration (FDA) investigator who specialised in biological and pharmaceutical product inspections and served as the Biologics Team Leader. During her tenure with FDA, she was responsible for two consent decrees, multiple warning letters, several new product approvals and three prosecutions. Ms. Fritz received many FDA awards including Investigator of the Year – Los Angeles District, FDA Outstanding Achievement Award, Biologics Team National Award, multiple Recognition Awards and Crisis Team Management Award. In addition to her FDA experience, Ms. Fritz has worked for the pharmaceutical and biotech industry in management roles leading quality assurance initiatives and activities as well as validation groups and working with manufacturing in variety of dosage forms to include sterile aseptic and terminally sterilised parenterals.
Ms. Fritz was previously Executive Vice President at Becker & Associates Consulting.