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...

Senior consultant in pharmaceutical and medical devices with emphasis in blood testingPharmaceutical and biotechnology quality assurance and control (QA, QC.)Regulatory compliance, consent decree and FDA batch record reviews-investigations; European audits.Plasma and blood collection centers and computerized donor record files.Blood and plasma quality assurance and control.Pharmaceutical QC methods development and review.Pharmaceutical validation of laboratory methods.Quality systems, quality control laboratory and development of standard operating procedures.Regulatory compliance audits; quality system audits.Vaccine stability, raw materi...

Commercial Products Chemistry with Specialization in Hair Care Products, Nutritional Supplements and Cosmetics. Skilled at the Chemical Analysis of Cosmetics, Foods, and Household ProductsTechnical Manager with diverse experience in industrial analytical testing laboratories, specifically pharmaceuticals, nutritional supplements, household products, paints coatings and cosmetics.Practiced in compendial procedures and methods including USP/NF, FCC, AOAC, ASTM and ACS.Method development and validation of analytical procedure along with designing stability programs.Laboratory management functions including sales and client contacts.Well vers...

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...

Over 15 years experience in pharmaceutical manufacturing of solid dose, liquid/semi - solids, and transdermal products.Expert in solid oral, liquids and transdermal pharmaceutical dosage forms.15 years of pharmaceutical Quality Assurance, research and development and commercial manufacturing experience.Process expertise in development and manufacture of solids, liquid and transdermal dosage forms.Supply chain experience in warehouse and distribution operations, including design and operation of Automated Storage and Retrieval Systems (AS/RS).Technical expertise in qualification of equipment, utilities and facilities, cleaning and process v...

Pharmaceutical management, manufacturing in China, supply chain expertise and coordinating major capital projects, new product introduction and new business development.Pharmaceutical technical operations with diverse international experience.Pharmaceutical management, manufacturing, supply chain, major capital projects, new product introduction and business development, with a focus on China.Particular expertise in operating at strategic levels in international and multicultural environments.Capital project management, site selection and team leadership.cGMP, regulatory affairs and compliance experience.

Analytical chemist specializing characterization and analysis of unknown materials, laboratory operations and REACH compliance, Certified Quality Auditor, CQA,Specialize in the analytical in-process / laboratory problem resolution and cGMP auditing / compliance and gap analysis of pharmaceutical suppliers.Process analytical technology solutions and project management.Preparations for REACH compliance in the European Union (EU).Established a satellite pharmaceutical testing laboratory in Hyderabad, India.Pharmaceutical ingredient supplier (cGMP) auditing (ASQ-CQA) including quality systems and regulatory affairs.Qualification of Asian sun...