Paul Bacchus

Mr. Bacchus has 15 years of experience working with ex-FDA investigators and district directors to assist 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 has a unique strength in 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), Quality Engineering techniques, Training on various Quality Engineering and Regulatory topics (e.g. CAPA, Problem Solving) and Quality System Remediation. Mr. Bacchus was a Chemist/Group Leader with Drug Manufacturer of IV Solutions and IV Pumps before moving into Quality Management in Medical Device manufacturing. He has held several management positions with McGaw Laboratories (now B.Braun), Sorin Biomedical/Mallinckrodt Medical, PS Medical/Medtronic and Baxter. He has experience with manufacturing of implantable heart valves, oxygenators, heart lung machines, ventilators, cardiac monitoring systems, catheters, tracheotomy and respiratory devices, silicone neurological and pain implants, vascular grafts and related delivery systems, tissue staining devices, and IV Solutions and pumps. Mr. Bacchus has been responsible for Quality Control (Inspection), Supplier Quality, Metrology (Calibration), Product Complaint handling and CAPA systems, Software Quality Assurance, and Training. Mr. Bacchus received his B.S. in Chemistry from Loma Linda University and Graduate School Certification in Advanced Manufacturing Technology from the UC Irvine.