Quality Systems Trainer
Damon Linder is a seasoned quality professional with over 20 years experience in engineering and project management. As the manager in the Global Program Management Office (PMO) at Invacare, he was responsible for the coordination of all project related activities for the Power Mobility Business Category. All aspects of project related activities are included such as: project selection, project prioritization, project planning and finance, resource allocation, approvals and senior management status reporting. Linder holds an MBA from Tiffin University and a B.S. in Mechanical Engineering from GMI Engineering & Management Institute. He is a certified Project Management Professional (PMP) from the Project Management Institute.
Danielle DeLucy has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.
Eric has worked in the Life Science industry for 10 years. He has experience training, consulting, and educating staff on process change, profitability, and patient improvement initiatives for employees in a variety of levels and roles. He is also a master presenter and storyteller. He has won first place in a humorous Speech contest, as well as first place in an International Speech contest. He is also the recipient of the Competent Communicator Award in 2013. Eric has his BS in Business Management, as well as his Masters in Organizational Management from the University of Phoenix.
Herbert ‘Herb’ Miller has over 20 years of success in making training ‘stick’. His Training & Development experience includes assessment, design, development, and delivery. His ongoing learning as a TQM practitioner, along with those training experiences have inspired ‘customer focused’ training that adds value to organizations. He has a commitment to delivering high impact, business focused and effective training that contributes to organizations’ bottom lines. His experience in change management and onsite investigations have provided him with insights and practical supporting activities to ensure that his coaching and training accomplishes its purposes. His degrees include Master of Human Resource Management and a B.A. in Organizational Management.
Julia Lawley has 15 years of experience in regulated industries. She has worked as a Master Trainer for Abbott, conducting corporate wide training programs in Root Cause Analysis, Conducting Investigations, and Writing Effective reports. Additionally, she worked as a European Deployment manager for global CAPA certification programs which included business assessments, compliance assessments, and training. She has developed and performed global nonconformity and deviation IT system training throughout Europe and Asia.
Kenrick is a highly skilled facilitator and training professional with over 11 years in FDA regulated industries including life science and biotech industries providing Management, Training, and Sales/Marketing Support. Kenrick has led global training initiatives, and received 2009 Project Award for serving as lead trainer and QIAGEN liaison for Mexico RCS Integration Project. He received his Bachelor of Science from Howard University.
Mike Murphy has 20 years of experience in manufacturing. He has a Six Sigma Masters certificate form Villanova University. He also has a Quality Improvement Certificate from Worcester Polytechnic Institute, where study included Failure Mode and Affect (FMEA) Analysis, Introduction to Six Sigma, Root Cause Analysis, and Building the Team Concept for Continuous Improvement.He also has his own patent: Murphy, Michael, et al. 2010. Bioengineered tissue constructs and methods for producing and using thereof. U.S. Patent 7,824,913, issued November 10, 2010.
Quality Systems Trainer
Peter Knauer has more than twenty years of international biomedical experience, primarily focusing on regulatory/compliance, product development and operations. Peter’s areas of expertise are Regulatory, supply chain development/management, risk management, CAPA/QEM, audit management and compliance/remediation issues related to biopharmaceutical and medical devices. He also consults routinely on IND/NDA and 510(k)/PMA submissions and acceptance. He was most recently Head of CMC Operations for British Technology Group in the United Kingdom, and has held leadership positions for Protherics UK Limited as well as MacroMed, Inc. (both acquired by of BTG). Peter is also Chief Operating Officer of BioUtah, the State of Utah’s independent Life Science trade association. Peter holds a Master’s Degree in Mechanical Engineering from San Francisco State University and a Bachelor’s Degree in Materials Science Engineering from the University of Utah.
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