Pharmaceutical Chemist and Former FDA Manager GMC, FDA Compliance and Expert WitnessRegulatoryFood and Drug Administration compliance.Prepare submissions to the Food and Drug Administration.Quality audits and implementation of changes.Simulated FDA inspection - quality and readiness audits.Establish and review quality assurance procedures for GMP and GLP.Develop and write appropriate Standard Operating Procedures (SOPs).Assist firms with Consent Decrees, Warning Letters, and 483s.Chemistry, Manufacturing, and Controls (CMC) expert.TechnicalLaboratory procedures and documentation.Pharmaceutical package and labeling and product compatibility...

Worldwide Pharmaceutical Expert Providing: Coordination and Technology of Pharmaceutical Products and Formulation and Development of Solids and ParenteralsSummaryExpertise in global product development, technology transfer/validation and business development.Designed and implemented development and registration strategies in U.S. and International arenas.Significant experience with all pharmaceutical dosage forms including peptides and novel delivery systems.Expert WitnessTwenty years of experience as an expert witness for pharmaceutical and formulation matters.

Former FDA Expert for Global Drug CGMP InvestigationsDomestic and foreign pre-approval and CGMP Investigations.Inspect and investigate activities of pharmaceutical manufactured drugs from an FDA point of view.FDA drug foreign Investigations included pharmaceutical manufactures in Canada, Belgium, Israel, Australia, Japan, Italy and France.Conducted independent international inspections to determine compliance with CGMPs of bulk drugs, new drugs.Validation of analytical methods.Laboratory FDA certification.Independent Consultant, PresentFood and Drug Administration, Philadelphia, PA, 19...

Consulting Chemist and Chemical Engineer-Validation Protocols for Analytical EquipmentPharmaceutical and medical device process and equipment validation.Pharmaceutical quality control, quality review of pre-BLA (Biologic License Application) drug product, and stability analysis.Validation of HPLC, UV-Vis spectrophotometer, particle size analyzer, and atomic absorption instruments.Created and wrote IQ/OQ validation protocols for sterile washers, dry heat ovens, and robotic filling and capping equipment used in aseptic manufacturing of implantable controlled release systems.Executed validation protocols for fluid bed granulators, tablet pres...

Consultant bioengineer expert in biomaterial science, nanotechnology, biosynthesis of polymeric biomaterials for implants and drug delivery.Synthesis of biomaterials and biomineralization, wherein a living organism provides an environment that controls the nucleation and growth of unique mineral phases.Synthesis and characterization of self-assembly of block copolymers.Nanostructured composites and polymeric biomaterials production and analysis.Consulting on artificial implants, drug delivery systems and medical devices

Pharmaceutical Quality Systems Implementation, Training and Audit ConsultantForty years of pharmaceutical and biotech industry experience - Production and development environments.Validation (computerized systems, equipment, processes), pre-acquisition - due diligence, quality assurance, compliance, quality control, research and development, technology transfer and clinical operations.Small and large molecule and vaccines, (Flu, Anthrax, and Rabies).International and domestic experience and assignments, (Europe, China and India).Exit strategy development, tracking and adjustment.Working with small, medium and large firms, assisting and man...

Chemical Hazard Communication Specialist Planning: Hazard Communication Training, Hazard Risk Assessments and Information Searching,MSDS, label production and review for U.S. (OSHA), Canada, (WHMIS), Europe and Mexico.MSDS ERP system integration, (SAP).Chemical, MSDS, label management systems, design, install and maintain.National and international product classifications, transportation and emergency response.Chemical, environmental, and health risk assessments.Process safety management and audits.Chemical, regulatory, toxicological and environmental information searching.Compose hazard communication plans, hazard communication training,...

Biochemist consultant specializing in many aspects of medical laboratory and regulatory mattersIn depth experience designing and equipping medical research laboratories, including hiring personnel.Familiar with Good Clinical Laboratory Practices, GMP, and FDA compliance.Experience working with both CDRH and CBER branches of FDA to ensure company compliance with FDA guidelines and 21 CFR regulations.Involved in the commercialization of more than 20 medical products.Conducted clinical trials at established hospital clinical laboratories and obtained approval for several medical diagnostic tests.

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...

Expert in analytical chemistry for pharmaceuticals, FDA issues and detection of bio hazards for Homeland SecurityCenter for Drug Evaluation and Research (CDER), former FDA employee.FDA review of new drug (NDA) and generic drug (ANSA) application submissions, FDA national Field operations, FDA compliance.Research and development programs related to homeland security.Department of Defense force protection and agent detection (novel devices, sensors and samplers) for the detection and identification of chemical and biological agents.Technology related to infectious disease countermeasures.Analytical chemistry related to drugs.Pharmaceutical a...