Patrick D. Williams Email & Phone Number

Over 15 years as a pharmaceutical microbiologist. Experience in quality control, quality assurance, operational quality, supplier management, and supplier quality auditing. Successful track record working with laboratory, manufacturing, regulatory, QA, R&D, and compliance personnel to manage and resolve complex quality and manufacturing issues. Expert resource for evaluation of Organizational Quality Management Systems in compliance with regulatory requirements - ICH Q7/8/9/10, EU and FDA 21 CFR Parts 11, 110, 210, 211, 820 and Industry Performance Standards. Experienced in the use of investigation tools, root cause analysis, and corrective action development.