PathWise Trainers and Contributors
PathWise uses internal and contract trainers who are experts in their field, and who keep up-to-date with applicable regulations and emerging industry trends, bringing an intimate knowledge of regulatory and compliance standards. Our trainers help simplify necessary concepts and processes, ensuring a quality system program that conforms to industry and regulatory standards.
April Santos has several years’ experience in FDA-regulated and ISO-certified industries. She jumpstarted her career in quality as a Lab Technician, and quickly escalated to becoming a Quality Assurance Supervisor. Her main responsibilities included non-conformance and CAPA, root cause analysis, risk-based thinking, management review, incoming raw materials inspections, equipment calibration, validation studies, supplier audits and environmental monitoring (just to name a few!). She also served as the Document Control Coordinator responsible for writing and revising Standard Operating Procedures. After gaining valuable experience in this role, she was promoted to a Regulatory Compliance and Quality Manager. April graduated from the University of Southern California (Fight On!) with a Bachelor’s in Biological Sciences. After graduating, April worked in cancer research at the Norris Comprehensive Cancer Center at USC’s Keck School of Medicine. April is currently finishing her certifications in Six Sigma Green Belt, Lean Management and Project Management.
Ernestine Harte is an accomplished Quality Assurance Professional and Trainer, with 20 years of experience working in FDA regulated industries. She has extensive experience in quality management systems, process improvement, vendor/supplier management, clinical start-up and GxP (Good Clinical Practice, Good Manufacturing Practice, Good Laboratory Practice, Good Distribution Practice) and other regulatory compliance activities. Ernestine worked as Director of Quality, managing the design, implementation, and oversight of the full quality system program. Ernestine has extensive experience in Document Management and Control, Change Control, Corrective and Preventive Action, Investigations and Complaint Management, and Supplier/Vendor Management. Ernestine has her Bachelor of Science and Organizational Management from Saint Augustine’s University, and her Master of Science Technology Systems, with a Quality System concentration from East Carolina University. She is also Lean Six Sigma Black Belt (LSSBB) Certified and is an American Society of Quality (ASQ) Certified Quality Improvement Associate.
Marvin has over 34 years of experience in various industries including foods, cosmetics, nutritional supplements, and personal care products. He has worked in Quality Assurance, Research and Development, Manufacturing, Maintenance, and Process Engineering. For the past 10 years he has led cross-functional teams in their quest for continuous improvement. Marvin is an ASQ Certified Quality Engineer, a Lean Six Sigma Master Black Belt, and a PathWise Certified Coach for Investigations and CAPA. He has a Bachelor’s Degree in Chemistry and a Master’s Degree in Engineering Management.
Dixie Webster is an industry professional with more than 26 years in the Pharmaceutical and Medical Device Industries. Over the last few years Dixie had the privilege of working as a part of an excellent, Inspection Management Team at the global level. Dixie has specific expertise and core strengths in the areas of CAPA, Quality Risk Management Systems, Data Integrity, and Training System Design and Implementation. Dixie has spent her career staying abreast of new regulations enabling her to design training programs that help companies navigate the seas of industry change.
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.
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.
Kelly Harkless is an accomplished Quality Assurance Professional and Trainer, with over 10 years of experience working in FDA regulated industries. She has experience working in the areas of Good Clinical Processes, Good Manufacturing Processes, quality assessments, auditing, technical writing, ISO, 21 CFR, and QSR. For the last several years, Kelley has worked training, development and instructional design. Kelly has commercially produced hundreds of lots of the FDA’s first approved immunotherapy for prostate cancer patients, and ensures the quality systems of organizations aspiring to launch clinical grade therapeutics. Kelly actively teaches and mentors others Quality Professionals in leadership. She received her Bachelors of Science from Georgia State University in 2008.
Collis’s passion is ensuring training drives the desired change within organizations. She knows no single approach is the one-size-fits-all solution and uses her experience to develop highly-interactive training solutions. Collis has over fifteen years experience in FDA Regulated Life Science Industries. She has worked with training development, training design, training delivery, Quality Systems, Lean Principles, technical writing, communications and project management. Collis has used her expertise to design and implement compliance and training initiatives with success. Collis has used her experiences from working in and with organizations who are in remediation with FDA and other regulatory bodies to address key concerns and share best practices with organizations world-wide. Collis has a Bachelor of Science in Business Administration and a Master of Arts in English, concentration in Technical and Professional Writing.
Nola Benstog is a diversified professional with a thorough knowledge of Quality Management Systems. She has over sixteen years of experience in the areas of Quality Assurance, Quality Control, Regulatory Affairs, Validation and Sterilization in both industry and consulting roles. She has worked in the medical device, pharmaceutical, combination product and nutritional supplement industries with experience ranging from start-ups to Fortune 100 and 500 companies. She began her career as a Technician in a Microbiology Lab and has held various positions up to the Executive Management level throughout her career. Nola received a Bachelor of Science in Microbiology from Weber State University and a Master of Business Administration from Utah State University. She has been an American Society for Quality (ASQ) Certified Quality Auditor (CQA) since 2007.
Danielle DeLucy has been in the industry for 15 years serving in numerous Quality Management Roles, including Director of Product Quality, Sterility Assurance and 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.
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.
During his career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions for major medical device companies, including a period as Corporate Director of Risk Management. He has over 36 years’ experience in the field of quality and regulatory affairs, including time as Director of Quality and Regulatory concurrently for four US sites. Currently he consults and provides training in the area of medical device quality, regulatory and risk management. With Stan Mastrangelo, he co-authored Lifecycle Risk Management for Healthcare Products: From Research Through Disposal published by PDA.
Mr. Bills was also a member of the adjunct faculty serving Virginia Tech’s graduate on-line degree program in Health Products Risk Management. ASQ has awarded Mr. Bills with Fellow status as well as Certified Quality Engineer, Certified Quality Auditor, Certified Manager of Quality and Organizational Excellence, and he is a Regulatory Affairs Certified by the Regulatory Affairs Professionals Society.
Additionally, Mr. Bills serves in international standards work, assisted in completing the revision of the third edition of ISO 14971 risk management standard as an international member of the technical committee. He also serves on the US national committee for the medical devices quality system standard, ISO 13485 and the AAMI technical committee CP, developing a combination products risk management guidance.