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...

Senior pharmaceutical R&D professional focused on analytical methods, methods validation, validation of computer systems and quality assurance and quality systems. Experience with parenterals, liquids, solids and semi-solids.Analytical Techniques: GC, HPLC, GC/LC/MS, FTIR, UV-Vis.Stability-indicating method development, validation and transfer.Analytical equipment validation: IQ, OQ, PQ.Part 11 compliance and GAP analysis.Validation master plan development.Stability protocol development.CTD dossier preparation.Cleaning validation strategy.LIMS and Laboratory Data Acquisition Computer systems.Coumadin, Percodan, Naloxone, Numorphan and N...

Doctorate in Biochemistry Experience in Academics, Biomedical Research, Process Development (Upstream and Downstream) of Bacterial Vaccines and Protein Therapeutics for Scale Up to ManufacturingIndustrial Biotechnology  Biotechnology facility design and layout, overall planning, project conception, budgeting and execution.  Over twenty tears of industrial experience in-process development of vaccines and biologicals in leading companies.   Research and development biotechnology management and transfer. Process development and optimization for bacterial vaccines.  Vaccine’s manufacturing unit layout an...

Over 30 years in the Pharmaceutical Industry, Beginning to End of Life-Cycle Management Consulting. Effective Expertise; Finding Solutions to Problems, Increasing the Efficiency of Development Summary  Pharmaceutical industry focus of new product development through life-cycle management, supplying over 30 years of industry experience in; efficient development, scale-up, transfer, problem solving, and commercial manufacture of pharmaceutical products. Formulation Scientist and Manager with emphasis in: CMC documentation, technology transfer, drug delivery, and process analytical technology. Appling technical expertise to problems...

CMC Consultant Specializing in the Development of Small Molecule Therapeutics (Analytical, Chemistry, and Formulation)Physical and analytical chemistry for CMC support of small molecule drug development.Chemical and formulation process development for API and various dosage forms.Material characterization of API and dosage forms for process development and troubleshooting.Analytical development, method validation and transfer for development and commercial methods; data analysis and interpretation of trends.Coordination of CMC activities with toxicology, clinical, QA/QC and regulatory affairs line functionsProject and supply chain manageme...

Pharmaceutical Analysis Expert in cGMP, Compendial, Near Infrared, Chemometrics/Multivariate, Process Analytical and Quality by Design AnalysisInternationally recognized expert in pharmaceutical analysis, regulatory compliance, laboratory management, design quality, and process analytical technology using spectroscopic methods including near infrared and multivariate analysis.19 years of pharmaceutical analysis in quality control, technical services and research and development.Technical Services Chemist with experience in troubleshooting High Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) (Hewlett-Packard, Varian he...

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...