Risk Management Consulting in Business Continuity Planning, Management, Testing for Small and Mid-sized Businesses Throughout the United States and Internationally. Business continuity Disaster recovery Financial technology controls Financial technology problem management Risk management Technology control Compliance: Federal Deposit Insurance Corporation (FDIC) and European  Pharmaceutical Research Association (PRA)  Standards. Cyber security Digital product management Financial customer service Project management Agile methodologies Microsoft and Google applications Rally

Pharma DMFs Compilation, Review and Filing in Various Regulatory Authorities and Marketing Procedures (CP/DCP/MRP/NA) i.e., Europe, EDQM, USFDA, TPD-Canada and TGA-Australia with Accordance to Filing Drug Master File (DMF)/ Active substance Master File (ASMF) for the domestic and global industries. USDMF: United States Drug Master File, (Open and closed part). Certificate of Suitability (CEP-COS) of EDQM. eCTD Compilation. DMF-Life cycle management. Technical Packages for Pharma Intermediates. DMF review as per ICH guidance. Analytical Method Validation and Development for API (Active Pharmaceutical Ingredients) and Pharma Interme...

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...

Leading Product Creation Though CE/FDA Submission, ISO, MDSAP Audit, R&D Documents (DHF): DI, DO, Risk, V&V plan, Protocols and Reports. Quality Procedures Implantation, Quality & Regulatory BinderAssurance, Quality Control, and Regulatory Affairs Manage and establish total quality system according to EN ISO 13485:2016, MDD/MDR Requirements and QSR (21 CFR 820). CE ( European Certification) certificated from technical documentation preparation through submission and external audit by notified bodies. Other countries certificates: Japan (including on-site audit), Korea, Canada, Australia, India with special requirements of different...

Ph.D. Biochemistry Food and Nutrition Expert. Food Emulsion Biochemistry and Physical Chemistry, Fermentation and Coagulation within Non-Dairy SystemsNutritional food and beverage product development, bridging between chefs, food technologists, protein chemists and biochemists, and executives.Industry research planning, methods development, rapid prototyping, product development management and troubleshooting, patent applications, product upscaling, co-packer and business-to-business relations, and brand ambassadorship to both businesses and consumers.Product-specific reduction and elimination of eggs and dairy ingredients in a variety o...

Polymer Scientist Working in: Polyurethane Applications, Polymer Foams, Polyurethane Dispersions, Coatings, Adhesives and Elastomers, Rigid foam formulations, Urethane Acrylates -Coating ApplicationsSummary Polymer Scientist that is creative, a problem-solver, strategic, with expertise in developing and commercializing of new products and intellectual properties for polyurethane applications, including polymer foams, polyurethane dispersions, coatings, adhesives and elastomers.  With a career resulting in many publications, under 100 patents, and a variety of commercial products that have generated more than $100 million in revenue....

Lab Testing Design: Drugs-Pharmaceutical Testing, Lab Operations, Maintenance, and Quality Control of Drug Testing Labs: Toxicology, Cannabis, Bioequivalence), Regulatory Requirements, BioequivalencSummary Over 17 years of drug testing experience on the development, validation, and application of analytical methods.  Equal experience in drug testing Labs design, operation, maintenance, and quality control of drug testing labs: Toxicology, cannabis, drugs, bioequivalence), cannabis regulatory requirements, bioequivalence studies, quality control studies, analytical laboratories’ quality assurance procedures.&n...

Expert in injection molding, molding equipment, tooling and resin selection. Injection molding process and injection molding equipment. Injection molding troubleshooting, tooling and molding equipment optimization. Plastic and polymer materials used in injection molding. Injection molding machines and selecton by part size and duty cycle. Top Entry (TE) robots. Hot runners for molding. Expert Witness Manufacturing Molding Equipment:  Fire Damage Case:  Provided reporting of equipment and recommendations for replacement of machines. Infringement case in the area of automobile parts.

Ceramics Technical Expert and Author of Numerous Patents and Training Manuals, Pertaining to the Use of Refractories in the Petroleum IndustryCeramics technical support: Training manuals, utilization of refractories in the petroleum industry including the development of numerous patents.Refractories engineering, overseeing more than 100 major turnarounds, providing ceramics and refractories support for over 35 years in the petroleum industry.Refractory lining materials for refinery and petrochemical applications including selection, design, installation, inspection, quality control, and dryout.Led refractory oversight for numerous project...

Mechanical engineer specializing in composite structure technology, design, development and failure analysis. Provides expert witness and litigation support related to: Consulting expert, testifying expert, design and analysis support, manufacturing/processing assessment, testing, inspection and forensic services, insurance claims, third party inspections.Development of large diameter pressurized FRP pipe products, pipe and joint fittings.Development of large dimeter (2.5-3.5m) FRP composite underground storage tanks built to UL1316 and BS standards.Design, manufacture and testing of composite wind energy turbine blades.Failure analysis a...