Biological Manufacturing: Auditing, Root Cause Analysis, Corrective, Preventative Action and GxP compliance. Biological and clinical manufacturing operations executive, providing a wide range of experience in quality leadership across many facets. Create, develop and recommend program and system changes pertaining to vaccine product release and deviation management resulting in more efficient product release to market and improved "right-first-time" manufacturing metric. Articulate leader with unparalleled work ethic coupled with a strong sense of urgency, keen interest and passion in making quality a key ingredient to the success of...

Commissioning and Qualification of Solid Oral Dosage Facilities, Operation Excellence in Supply Chain, Drug Master Files Review, Validation of Analytic Control, Implement EHS Management Systems Quality management system: Design, Standard Operating Procedures (SOP) training, auditing, upgrading quality systems. Design of oral dosage manufacturing processes. Design of manufacturing process and equipment’s User Requirement Specification (URS). Commissioning and qualification of process equipment, clean rooms, HVAC, and purified water system. Market research, business plan, product targeting. Regulatory affairs: Review of parts 1...

Specialty Chemicals & Pharmaceutical Supply Chain-Change Agent, Regulatory, EPA, OSHA-PSM and Global Manufacturing ExpertPharmaceutical and specialty chemical operations with 20 years’ in supply chain Leadership for large facilities, providing technical solutions in challenging environments in union and non-union members. Manufacturing and operations professional, action-oriented, building effective teams and delivering positive results with unlimited drive for continuous improvement in fast paced, global businesses. Change agent and transformative leader in global manufacturing footprints leading to increased efficiency and throughp...

Expert in Formulation Development, Design, Characterization, Capital Equipment Selection, and Processing of Powder Based Materials, with Associated Analytical SciencesTheory, design, applications and practice of Spray drying and powder technologies of forty years in the following areas:Formulation development, design, characterization and processing of powder based materials, with associated engineering and analytical sciences.Equipment design and fabrication, component specification, vendor selection, and procurementProcess design, instrumentation and control.Equipment manufacturing design and delivery of spray dryers and other capital eq...

Pharmaceutical Certified Quality Auditor with Focus to: Document/Data in Quality Management System, cGMP, GLP, GCP, ICH, EP, USP, NF, DEA, SOPs and ProtocolsExperienced cGMP and ASQ Certified Quality Auditor (CQA) solving quality issues and improving quality systems. Document/Data auditor for Quality Management System, cGMP, GLP, GCP, ICH, EP, USP, NF, DEA, SOPs and protocols. FDA compliance in a pharmaceutical environment; FDA regulations including 21 CFR 11, 120, 210/211, and 820; plus, ISO 13485. Demonstrates proficiency in reviewing, editing, and writing SOPs, ensuring accuracy, clarity, and compliance with all applicable guideli...

Medical Device and Pharmaceuticals Quality Management Expert Witness with Experience in Clinical Research, Regulatory Affairs, and ISO-9000 ComplianceQuality assurance, clinical research and regulatory affairs to assist in quality systems improvements, product development, and marketing approval of medical products.Quality management for medical devices, pharmaceuticals, and biologicals.GLP, cGMP, GCP, ISO-13485 and ISO-9000 regulations as they apply to quality systems audits to assure compliance with regulations and standards.Expert Witness ExperienceFive cases, one court testimony.Assisted in the reversal of three Federal Court consent...