Amy Bradford
Principal Consultant-Quality/Micro CAI
Goal oriented quality assurance/quality control/operations technical professional and collaborator with over 20 years’ experience in operations and quality in FDA/EPA regulated industries ranging from process design through industrial production level. Understanding of both API and finished product regulations. Experience in compliance of major systems and equipment including facilities/utilities, manufacturing processes and testing methods and laboratories. Expertise in major quality systems development and implementation, validation of labs, water systems, and processes including cleaning validation. Experience in process and lab investigations and CAPA management, and auditing of suppliers/co-manufacturers. Strengths include quality project management, laboratory operation and method validation, cleaning and process validation, batch documentation and disposition, technology transfer, planning and organization and technical writing. Understanding and application.
