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...

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...

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.

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...

Canadian regulatory affairs expert prepares pharmaceutical and medical device submissions and audits manufacturing quality practicesPharmaceutical Good Manufacturing Practices (GMP) for Canada.Regulatory Affairs Canada, submission preparation.Change control and complaint management.Pre-approval inspections.Pharmaceutical Quality Systems, clinical trial supplies.Qualification and validation: process, equipment, cleaning and test methods.Water for pharmaceutical purposes.Bioanalysis.Adverse event management; deviation and out-of-specification investigations.Sterile product manufacturing; environmental monitoring.FDA, QA, QC, quality assuran...

Pharmaceutical Compliance Consultant: FDA Regulations & Submission with Management Experience at Indian Pharmaceutical CompaniesPharmaceutical quality assurance and regulatory affairs.Skilled in Indian pharmaceutical research and development with leadership positions at Ranbaxy Laboratories, Strides Arcolab, Unilever and Ciba Geigy, all in India.Pharmaceutical GLC and GMC compliance audits, QA operations and regulatory submissions.Pharmaceutical quality control for analytical equipment, method development and validation.Synthesis of active pharmaceutical ingredients (API) and API isolation, identification, impurities and degradation produ...

Consultant for drug development for cardiovascular therapeutics and heart failure; experienced as an expert witness.Drug development, specializing in cardiovascular therapeutics.Expert witness and the evaluation of cardiovascular drugs.Drug safety.Medical writing: Protocols, study reports, manuscripts, FDA submission (NDA) briefing documents and investigation of new drugs (IND).Product support-promotional review and medical information.Evaluation of previously monitored clinical studies.Principal Investigator in the following areas:Vasodilator and inotropic drugs.Vasodilator therapy for acute myocardial infarction.Nitrates and hydralazin...