LAURIE TADDONIO, LMT Consulting LLC: Laurie is an independent consultant with 25+ years of experience in the FDA-regulated industry, including 10 years with the FDA as a Bioresearch Monitoring Specialist Investigator, BIMO Program Manager, International Inspection Team member, and instructor and manager of FDA’s New Investigator and Analyst Training. Laurie has been a consultant 15+ years assisting companies internationally with QA and compliance. Her expertise includes clinical quality systems assessments and consulting, SOP evaluations and writing, training, mock FDA inspections, preparation for and assistance during FDA inspections, investigations of suspected fraud and scientific misconduct, and QA audits of sponsors, CROs, clinical investigators, and IRBs. She has worked on projects ranging from simple audits to complex criminal investigations and has proactively helped companies in achieving successful outcomes in obtaining product approvals as well as in response to FDA 483s, Warning Letters, Integrity Holds, Application Integrity Policy (AIP), and Consent Decree.