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Barbara Munch

GlaxoSmithKline
Barb Munch, BS, is Director, R&D Pharma GLP Risk Coordinator in global toxicology, within GlaxoSmithKline (PA, UK). This group conducts GLP in-vivo and in-vitro toxicology studies for pharmaceutical test articles. Her 39-year career has been in the nonclinical regulatory environment, initially assessing and applying the GLP US FDA regulations, and later including MHRA GLP MA regulations
and OECD principles. Barb manages the risk of conducting GLP work across GSK R&D and has oversight of all regulated SOPs. Based on her knowledge of tox processes and GLP regulations, she provides interpretation of difficult regulatory issues. Barb leads multi-disciplinary teams to develop and implement GLP projects based on internal and external audit findings and updated regulatory guidance, ensuring GLP compliant business practices. She is the primary business lead for FDA audits, and supports GLP MA audits.Barb also has experience in histology, necropsy, computer system administration / validation, and as a QA auditor. Ms. Munch earned her Bachelor of Science degree in Animal Science from the University of Maryland, College Park.