Paul has over 35 years of experience assisting clients in the drug, medical device and biotechnology industries to develop and implement quality assurance, manufacturing, software validation and regulatory strategies for compliance with FDA regulations during routine operations, under consent decree or other adverse regulatory scenarios.
He focuses on the design and implementation of sustainable and effective Quality Systems to improve productivity and compliance. His expertise includes Mock FDA Inspections, Auditing (CFR820, 210/211, Software Validation), implementing Quality Engineering techniques, training on various Quality Engineering and Regulatory topics and Quality System Remediation.
Prior to consulting, Paul held management positions with McGaw Laboratories (now B. Braun), Sorin Biomedical/Mallinckrodt Medical, PS Medical/Medtronic and Baxter.
Paul received his B.S. in Chemistry from Loma Linda University and Graduate School Certification in Advanced Manufacturing Technology from the UC Irvine.
