Jennifer Caldwell, ASQ-CQA, ASQ-CPGP, has over 20 years of industry experience in quality roles focused in GCP (CRO) and cGMP (contract manufacturing organizations and cold chain distribution) environments. She has over 20 years’ experience assessing compliance and performing audits in GMP and GCP regulated industries. In addition, Jennifer’s expertise includes preparation for and support during regulatory inspections for pre-approval and general inspections by the FDA, MHRA, Russian Federation and other foreign regulatory authorities. Jennifer’s experience also includes investigation of customer complaints, batch review/release, CAPA development and implementation, deviation review and approval, root cause analysis, risk management, compliance review of CMC documentation, Annual Product Review (APR), Quality Management Review, change management and SOP development and management. Jennifer holds a Bachelor of Business Administration, emphasis in computer information systems, from Morehead State University and is a Certified Quality Auditor (CQA) and Certified Pharmaceutical GMP Professional (CPGP).