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...

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...

Experienced biostatistican to support pharmaceutical data analysis in drug development, efficacy screening and clinical trials.Statistical AnalysisProtocol Development - Pharmaceutical, Biotech, Medical Device, NIHPharmacokinetic (PK) AnalysisSAS ProgrammingStatistical Report WritingData and Safety Monitory BoardSensitivity Analysis2002 - Present Independent ConsultantStatistical services to the pharmaceutical, biotech, and medical device industries and the National Institute of Health (NIH).Statistical services...

Experienced applying mechanical engineering tools to biomechanical applications, including computer aided design, (CAD) and finite element modeling, (FEM) techniques. Medical device evaluation and testing. Laboratory testing for hard and soft tissue, joints and other devices such as artificial limb prosthetics and external fixation devices. Medical device testing. Testing of spinal implants and orthopedic devices for FDA submission. Biomechanical evaluation and fatigue analysis of silicone breast implants.Medical device evaluation and testing.Skilled in mechanical laboratory testing and procedures for hard and soft tissue, joints and ot...

Urethane chemist with experience in specialty films, corrosion inhibitors and chemical trade with China.Chemical product commerce with China.Polyurethanes chemistry - polyurethane flexible foam production based on polyether and polyester polyols.Specialty films production by the solvent band casting process.Corrosion inhibitor production; specialty chemical production and sales; and production of artificial sweeteners.Operations, new product formulating, research and development.Plant and chemical process shut down.OSHA, EPA and regulatory compliance in chemical plant operations and chemical plant shut down.Increased profits after restruct...

Consultant for Medical Device Software and Compliance and ValidationFDA and ISO compliance, particularly for medical devices and related software systems.Quality system auditing.Supplier quality assurance, audits and FDA checks compliance.Software verification and validation.Software project management.Process assessments and improvement.Computerized systems validation.Software risk management.Software life cycle documentation.Quality system training.Independent ConsultantAbbott Laboratories Diagnostic Division, Irving, TX, 1986 - 2009Manager, Division Software Quality Ass...

Consultant for Medical device FDA/ ISO Regulatory Compliance.Medical device FDA/ ISO regulatory compliance.Design control systems, both hardware and software, for medical devicesRisk analysis, vendor qualifications and documentation related to medical devices.Software and process validations.Design and manufacturing engineering in flowmeters.Contract Manufacturer Organization (CMO) selection and qualification for medical devices.Drawing and document control systems, configuration and management.Human factors programs.Component acceptance procedures/ non conforming product disposition.Audits, gap analysis and response to FDA 483 forms and w...

Consultant for Medical Device Validation and Blood Bank Operations and Collection Devices per FDA RegulationMedical device submissions, regulatory affairs related to medical devices and pharmaceutical, good manufacturing practices (GMP) and Quality Systems Regulation (QSR).FDA compliance procedures including process validation, product validation, software validation, warning letters, consent decree resolution, compliance audits, supplier audits and ISO registrations.Extensive and broad knowledge of U.S. FDA quality and regulatory body regulations.Specializing in medical device submissions, regulatory affairs, and Good Manufacturing Prac...

Medical Devise Regulatory Consultant with Class II and III Implantable Medical Device Experience: Cardiovascular Grafts, Surgical Mesh, Heart Valves, Periodontal Implants, Sutures and LigamentOver 25 years of experience in medical devices.Experienced in all aspects of medical device product development, including design, laboratory and clinical testing, manufacturing, labeling and quality systems.Extensive experience in medical devices pharmaceutical and in vitro diagnostics industries.Extensive experience with Class II and Class III implantable medical devices for cardiovascular grafts, surgical mesh, heart valves, periodontal implants,...

Consultant for Pre FDA Quality Audits for Medical DevicesMedical Device quality assurance and regulatory compliance professional possessing over 28 years' experience.Manufacturing, pharmaceutical, biologic, and medical device operations.21 years of employment with the FDA, primarily as a Medical Device Investigator.Professional consulting; FDA Medical Device Quality regulations and FDA compliance.ASQ certified, (QBA) medical device regulatory compliance and non-technical quality assurance expert, specializing in medical device quality systems.Failure modes and effects analysis of medical devices.Metallurgical engineering technology as appl...