Laura B. Scott

Laura B. Scott has been in a leadership role in the pharmaceutical industry for over 25 years working for both big pharma as well as contract research organizations.  She started in the consulting business in 2008 offering a variety of services at cost competitive rates to the pharmaceutical industry.  

Prior to consulting, Laura provided the leadership for a QA organization across multiple locations including both Operational QA and Quality Systems (Corrective Action Preventive Action, Audits, Annual Product Review, and Validation Support).  She has GMP compliance experience in manufacturing (solid and sterile), packaging, and testing in support of investigational and commercial materials as well as GLP compliance experience in support of dose prep and analysis, bioanalytical, safety pharmacology, and drug safety.  She also has experience in providing leadership for non-traditional QA functions such as Quality Control, Cleaning Validation, Calibration, Archive, and Chemistry Manufacturing and Controls (CMC).

Laura has an extensive background in Quality Assurance, specifically 21CFR Parts 11, 210, and 211 Good Manufacturing Practices, Part 58 Good Laboratory Practices, and EU Good Manufacturing Practices.  She has provided the leadership for numerous regulatory agency inspections (FDA GMP, GLP, IRB;  MHRA; German; Japanese) as well as the leadership for numerous external audits (contract laboratory, manufacturing, packaging and raw material/API suppliers).  She participated in a tripartite internal audit of French, German, and US Hoechst Marion Roussel locations.  She executed an assessment at multiple US Aptuit locations based on FDA’s Six Quality Systems.  

Laura has developed and performed numerous GMP training sessions, the most recent focused on GMP history, FDA challenges and initiatives, API GMPs (ICH Q7), Product GMPs (21CFR Part 211), Excipient GMPs (IPEC), Quality Risk Management (ICH Q9), and Pharmaceutical Quality System (ICH Q10).  

Laura has a BS in Biochemistry from Texas A&M University.  She gives back to her community by volunteering at Turnstyles (Catholic Charities thrift store) and is a member of the choir at her church.