Maxine Fritz is the Director, Pharmaceutical and Biologics Quality Systems and Compliance Practice at BECKER CONSULTING. Ms. Fritz provides strategic advice, insights to all levels of managment involved or planning involvement with FDA, product regulatory development, pre- and post-product approval support, submission advice and support, quality systems implementation, and compliance and enforcement action advice and support.

Ms. Fritz develops and implements quality system improvement plans that assure business needs and regulatory requirements are properly balanced so that compliance is achieved without compromising business objectives. She provides training and coaching to all levels of management regarding FDA’s expectations and quality management responsibilities. She is a former FDA investigator who specialized in biological and pharmaceutical product inspections and served as the Biologics Team Leader. Ms. Fritz has 23 years of combined FDA/industry management experience, including a variety of pharmaceutical quality activities such as quality assurance senior management, validation, vendor qualification, internal/external audits, batch record review, product release, investigation of non-conformances, current Good Manufacturing Practices (cGMP) training, and aseptic manufacturing. This unique combination of experience allows her to provide clients with strategic, tactical, and technical advice to assist them developing practical quality assurance, manufacturing, and regulatory strategies for compliance with FDA regulations.

Ms. Fritz holds a BA from the California State University. Send email to maxine.fritz@becker-consult.com.