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...

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...

Ph.D Pharmaceutical Regulatory and Laboratory Compliance, Quality Assurance and Controls (cGMP, FDA, ICH, EMA, ISO) ConsultantPharmaceutical and biotechnology product development, management of cGMP compliance quality systems, quality control, quality assurance, (in unique dosage forms, and sterile-nonsterile processing methods).Laboratory quality systems for both pharmaceutical development and quality control testing.Complete laboratory outfitting including qualification and method implementation.Test method development, transfer and validation.Analytical measurement and techniques.Auditing systems and processes.Analysis of APIs, raw mate...

Pharmaceutical Analytical Chemistry Consultant Specializing in Method Development, Method Validation, Cleaning Validation and Verification, Drug Stability and cGMP, FDA and ICH Quality and Compliance.Analytical method development and method validation for small molecule pharmaceuticals.Cleaning validations and cleaning verifications.OOS (Out of Specification) and OOT (Out of Trend) investigations.Stability management.Setting specifications for finished products and API.Project management for CROs (Contract Research Organizations).Formulation development support.Pharmaceutical quality control.Protocol and SOP (Standard Operating Procedures...

Experienced pharmaceutical laboratory manager and analytical chemist with expertise in GLP and GMP compliance and solid dosage forms.Extensive experience in pharmaceutical, nutraceutical and chemical industry analytical laboratories.Laboratory management and analytical laboratory improvement, cGMP and GLP compliance and problem resolution.Pharmaceutical process, cleaning and analytical methods validation.Solid dosage for OTC drug products.Responsibility for QA/QC functions for testing, complaint handling, customer audits and data analysis for over 300 different drug products.Training on cGMP and GLP compliance and problem resolution.Docume...