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.

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...

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...

Pharmaceutical Quality Assurance Quality Control expert with experience with U.S., E.U., Canada, and India regulationsPharmaceutical Quality Assurance and Regulatory Affairs.Compliance audit, Quality Operations and Regulatory Submissions.Design and implementation of Quality Systems and regulatory compliance programs.Domestic and international quality and regulatory compliance.Managing contract / vendor supply chain quality programs.Developing and delivering GMP, GDP, DI procedure training programs.Leading the Quality efforts to successfully remediate recurring failures.Generation, maintenance and revision of SOP's, specifications, procedur...

PhD Biostatistician with expertise in Regulatory (FAD and EMA activity), Data - Safety Monitoring in the Pharmaceutical and Medical Device Industries. Scientific Advisory Participant.Biotechnology FDA and EMA submission in the pharmaceutical and medical device industries.Biostatical litigation specific to pharmaceutical and medical devices.Pre- and Nonclinical, Phases I - IV in biostatistics, data management, statistical programming, and etechnology across various therapeutic areas.Analysis of over 420 clinical studies, with over 30 in Integrated Summary of Safety and Integrated Summary of Efficacy (ISS/ISE).Build effective innovative an...

Pharmaceutical GMP Consultant with expertise in GMP, QMS, Documentation, Validations, Plant setup, Training and development, Quality control, Audits, environmental monitoring, for Solid orals, Liquid Sterile, solid orals, liquid orals, dermal products; various dosage forms. Managing strategic and operational performance of Quality Department providing: Development and implementation, Standardized quality system processes, Review of standards for quality control, Regulatory compliance, Quality control systems and procedures (GLP). Pharmaceutical industry (Formulations). Quality Management System (QMS); Complaints, recalls, deviati...