PDA 538.3 Quality Culture Assessment

Featured Presenters

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  Danielle Duran

  Director, GxP Training, Nestle Health Science

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  Danielle Duran

  Nestle Health Science

  Danielle is the Director, GxP Training at Aimmune Therapeutics, a Nestle Health Sciences Company, where she leads the development of a GxP Learning Organization and supports Quality in Learning and Training Systems. She has spent nearly 20 years learning and continuous improvement in biotechnology, tech startups, K-16 education, philanthropy, and non-profit. Her expertise is in leveraging and understanding how people learn from a neurological perspective combined with how people understand behavior and social interactions to drive meaningful change. She arrived at Nestle via Aimmune, and before that, BioMarin, where she led a training team in Technical Operations, led global initiatives for training system improvements, and consulted globally on effective training design. Danielle lives in Marin County with her 8-year-old daughter and enjoys time in outdoor sports, traveling, and building global relationships to support effective learning.

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  Amanda McFarland, MS

  Senior Consultant, ValSource, Inc.

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  Amanda McFarland, MS

  ValSource, Inc.

  Amanda McFarland is a quality risk management and microbiology senior consultant with ValSource, Inc. She specializes in the creation and implementation of risk management programs and developing risk-based strategies for use in clinical and commercial settings. Amanda is an active member of the Parenteral Drug Association (PDA), co-chair of the PDA ANSI standard on QRM in aseptic processing, a member of the PDA Regulatory Affairs and Quality Advisory Board, an instructor at PDA -TRI on quality risk management and co-lead of the Kilmer Regulatory Innovation team. She has a BS in entomology and an MS in mycology, both from the University of Florida. She can be contacted at  [email protected].