Barb Maley is a Quality Assurance professional with 29 years of research experience including 26 years within the pharmaceutical industry (GLP and GCP) and 17 years hands-on experience within Quality Assurance and Continuous Improvement. Barb has extensive experience providing quality consultation and execution of process-based data mapping/traceability and auditing. She also has detailed knowledge of GCP, Quality Systems Management, Clinical and post-marketing Promotional Material Regulations, Inspection support through inspection hosting, development/provision of regulatory inspection responses and mock inspection activities. She earned a Bachelor of Science in Biology from State University of New York College at Oswego.