Maxine Fritz
- Role
- Executive Vice President at NSF
- Location
- San Luis Obispo County, CA, US
- LinkedIn followers
- 500 followers
About Maxine Fritz
Company Overview: NSF International is a growing, global, public health and…
Experience
Executive Vice President
Aug 2012 — Present · Washington, DC, US
Provides strategic advice, insights to all levels of management 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.\\\\n\\\\nDevelops 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.\\\\n\\\\nProvides training and coaching to all levels of management regarding FDA’s expectations and quality management responsibilities.\\\\n\\\\nA former FDA investigator who specialized in biological and pharmaceutical product inspections and served as the Biologics Team Leader.\\\\n\\\\nHave over 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, cGMP training, and aseptic manufacturing.\\\\n\\\\nThis unique combination of experience provides clients with strategic, tactical, and technical advice to assist them developing practical quality assurance, manufacturing, and regulatory strategies for compliance with FDA regulations.\\\\n\\\\nI and my staff are experienced in linking companies\' regulatory, development, and quality plans to their business strategy.\\\\n\\\\nBecker & Associates Consulting was acquired by NSF International August 2012.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n
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