Chemical Engineer Consultant: Water, Process Utilities, Sustainable Fuels and Biomass to Energy.Pharmaceutical water system design, equipment, pharmaceutical water standards, P&ID, facilities construction and validation.Process engineering expert with a focus on water treatment facilities, process utilities, sustainable fuels, petrochemicals and biomass to energy.Analysis of construction contracts, engineering claims and engineering standard of care issues for process design and construction.Twenty years of experience in membrane filtration with a focus on pharmaceutical and biotechnology waters, water for injections and purified water sy...

Global Quality Expert for Sterile Injectable and Medical Devices with Extensive Experience Interacting with FDAQuality for small and large volume sterile injectable and medical devices.Quality assurance policies for sterile injectable dosage, and product assurance.Procedures for out of specification (OOS) results for analytical and biological laboratories for sterile injectable dosage.Quality investigation teams to investigate high and medium level deviations to determine root cause, implement appropriate CAPAs and check for CAPA effectiveness.New product development and sterility assurance of sterile disposable products.ISO 9001 certifica...

Pharmaceutical and Biotechnical Quality Assurance Consultant - Regulatory, GMP, GLP, ISO, ICH, FDA, Drug Development, Manufacturing and Aseptic Processing. PhD Consultant Specialized in New Product Research, Scale-Up, Compliance, Production Development, New Applications and CommercializationPharmaceutical and biotechnical quality assurance.Broad knowledge of GMP, GLP, ISO, ICH, FDA and International regulations.Managing multiple projects and complex priorities.Drug development, pharmaceutical manufacturing and aseptic processing principles and requirements.Focused AreasProduct releaseProduction batch recordChange controlCommissioning,...

Development and Implementation of Phase-Specific Quality Systems and Pharmaceutical Production and TestingPharmaceutical quality assurance management and corporate quality strategy planning.Development and implementation of phase-specific quality systemsIdentifying and correcting road blocks to efficiency and complianceGMP facility design, construction management, validation and licensing of GMP manufacturing facilities.Proven success in U.S. and E.U Inspections of manufacturing and laboratories.Over 20 years of valuable experience developing and managing highly productive work groups in small to mid-size pharmaceutical.

Recombinant DNA E. Coli Fermentation Development Expert Specializing In Fermentation, Scale-Up, Technical Transfer and ValidationDevelopment of GMP E. coli, yeast, and actenomycete, fermentations for pharmaceutical production.Scale up of GMP E. coli, yeast, and actenomycete, fermentations for pharmaceutical production.Technical transfer of GMP E. coli, yeast, and actenomycete, fermentations for pharmaceutical production.Validation of GMP E. coli, yeast, and actenomycete, fermentations for pharmaceutical production.

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...

Global Pharmaceutical Creation and Implementation of Systems to Increase Efficiency, Sustain Regulatory Compliance, Interpretation of Regulatory Requirements: Quality Systems, cGMP, Good Laboratory Practices, IND/NDA/ ANDA/ DMF and CAPAGlobal market place creation and support; implementing systems, increase efficiency and sustain regulatory compliance in the pharmaceutical industries.In-depth knowledge and interpretation of regulatory requirements as applied to quality systems, cGMP, Good Laboratory Practices, laboratory equipment expertise.Vendor assurance programs, stability programs, validation (equipment, process, and analytical), manu...

Pharmaceutical and Bio-Pharma Product engineering for HPLC (High Performance Liquid Chromatograph), Research and Development, Manufacturing, Lifecycle and Market IdentificationProcess analytics in process manufacturing, research and development.Evaluation, installation and implementation of process analytics (PAT).Development of process analytics and PAT support teams.Online analyzers for industrial health and safety applications.Evaluate, identify, implement online analyzers for environmental discharge monitoring.Assist pharmaceutical/biopharmaceutical industry with establishment of PAT programs.Process analyzer qualification and validati...

Former FDA Investigator - Expert in Regulations, Interpretations, Medical Devices, and Dietary Supplements.Former FDA Investigator.Technical writing to build and implement quality systems.Comprehensive audit and gap analysis.CAPA and FDA responses and complaints including: Investigations, resolution, root cause analysis, corrective action plans, preventative action plans and CAPA effectiveness resolution and documentation.Employee training; laboratory and quality.Formal FDA Training in multiple program areas: Drugs; medical devices; process validation; industrial sterilization; biologics; dietary supplements; food and feed.Ability to audit...

Manufacturing, Engineering/Maintenance, Quality/Compliance Expert: Supply Chain, R&D, Operational Excellence, and EH&S. Pharmaceutical -Medical Turnarounds, Quality Systems, Regulatory Compliance, Process Improvement, Lean, Six-Sigma & Problem Solving Methodology, Environmental, Health & Safety, New Product Development & Launch, Strategic Vision, Planning & Execution, and Culture Development & Transformation SpecialistPharmaceutical and medical device strategic planning, organizational development, supply chain management, and business focus.Implementing creative and innovative processes and solutions from a strategic, overall perspectiv...