Lisa Schuster

Background

About Lisa Schuster

Engineering professional with experience and background spanning regulatory, quality, design, and testing. Contributed to new drug and medical device submissions. Developed and implemented quality systems, including SOPs, in accordance with ISO, GxP and QSR regulations. Planned, developed, and executed testing to show that software and/or equipment functioned per intended use. Audited manufacturers and clinical research organizations for GxP and 21 CFR Part 11 compliance. Provided input for design controls, utilized design of experiments and statistics to evaluate improvements, and specified, purchased, and installed capital equipment. Managed various validation and quality projects, which met schedule, resource, and budget constraints. Recognized for initiative, intelligence, high standards, and detail focus in accomplishing results. Technical Expertise/Skill Set Regulatory Regulatory Affairs Certified - 2007 FDA and EMEA submissions – IMPD, IND, NDA, MAA, 510(k) Quality Systems per ISO 13845, 21 CFR 820, 21 CFR 210 & 211, ICH Q7 GxP and 21 CFR Part 11 compliance auditing Qualification and Validation Computer System Validation for software & databases (C++, SQL, and XML) and automation systems (PLC and DeltaV) HVAC equipment/system qualification and clean room performance Manufacturing – Process Engineering Statistical Process Control, Design of Experiments, Shainin techniques Material Qualification Troubleshooting, process improvements, and change requests Injection Molding