Stelex U / Instructors

J. Scott Hodges, Ph.D.

SUBJECT MATTER EXPERT – CSV, GxP, 21 CFR 11, RISK ASSESSMENT, QUALITY AUDITING (FOR FDA-REGULATED INDUSTRY)

Scott Hodges is a Project Manager at Stelex, and is also Operational Manager of the Stelex University program. Scott manages validation and quality system projects, and is a principal instructor for Stelex U offerings. Dr. Hodges is responsible for proposal development, creation of project plans, and supervising the development and execution of CSV documentation for the system life cycle. Scott authorized Stelex’s System Life Cycle SOP and actively supports the creating and revising of company SOPs.

Heidi Krueger, ASQ CQA

SUBJECT MATTER EXPERT – CSV, GxP, RISK ASSESSMENT, PROJECT MANAGEMENT METHODOLOGY, DECOMMISSIONING (FOR FDA-REGULATED INDUSTRY)

Heidi Krueger is a Senior Consultant for Stelex’s Laboratory and Manufacturing department. She has over twenty years of experience in both FDA and EPA regulated industries in the areas of Validation, Laboratory Quality Assurance Management, Auditing, Analytical Method Development and Training, Inorganic and Organic Chemical Laboratory Testing, Pre-Clinical Research, GLP Compliance, and Project Management. Ms. Krueger is a Stelex University Instructor and has participated in development and presentation of Stelex University courses in general software system lifecycle documentation and implementation; auditing procedures and techniques; 21 CFR § 11; history of FDA; and basic GCP regulatory training.

Chris Birney, MCSE

SUBJECT MATTER EXPERT – LIVELINK

Chris Birney is a Livelink Subject Matter Expert with over ten years of IT experience as a Senior Systems Administrator, five of which are as a Livelink Subject Matter Expert. Clients have included Government Agencies, Industrial concerns and the Pharmaceutical and Medical Devise industries.

Kelly Jacoby, ASCP

SUBJECT MATTER EXPERT – ASSET MANAGEMENT SYSTEMS

Kelly Jacoby is a Senior Consultant for Stelex’s Strategic Partnership Services department providing regulatory compliance consulting services for the FDA regulated industries. Ms. Jacoby has successfully implemented enterprise level asset management systems and has served as project leader for many quality improvement projects. She has many years of experience as an Education Coordinator and Quality Assurance Auditor.