Jane R. BrownCompliance Consultant
BS, Food Science and Technology, North Carolina State University
Jane has more than thirty years GMP/GLP/GCP compliance experience in the pharmaceutical and medical device industries. She has a broad knowledge of global regulatory requirements and an awareness of emerging issues and trends in the regulatory environment.
Jane is experienced in conducting GMP audits for commercial operations and clinical trial supplies manufacturing and testing. She is also experienced in auditing API manufacturers, raw material suppliers, contract manufacturers, and analytical and microbiological testing laboratories. She has conducted numerous pre-approval inspection assessments, and provided guidance and advice on regulatory inspection preparation and management.
Jane has significant experience in assessing Quality Systems to ensure they comply with global regulatory requirements and industry best practices. She is also knowledgeable and experienced in the principles of Quality Risk Management. She has excellent communication skills, which are essential in providing advice and guidance in the practical application of regulatory requirements.