Ph.D Scientist with Expertise in MRI Imaging, Pharmaceutical Biomarkers, In-Vivo Imaging and Medical Device ExpertSummaryDeveloping imaging biomarkers for the pharmaceutical and medical device industries.Biomedical imaging and computer sciences.Magnetic Resonance Imaging (MRI) data acquisition and data analysis, image and signal processing techniques, numerical methods, multicompartmental models and linear systems.Development and validation of quantitative imaging (MRI) biomarkers.Project management and study design of scientific (R&D) projects.Site training and implementation of in-vivo imaging studies.Quality control and analysis of imag...

PhD with expertise in Pharmaceutical Assessments, Investigations, 3rd party certifier, and Regulatory; FDA EMA, MHRAOver 33 years' experience in quality, microbiology and regulatory affairs.Pharmaceutical assessments, prioritization, establishment of realistic timelines for the implementation of consent decree commitments and 3rd party certifier of deviations-investigations.Ensure the robustness of quality systems - change control, product complaint handling, revision of SOPs, and control of 3rd parties.Quality assessment of sterile injectable, small molecules and biological as well as other dosage forms.Solid and liquid oral dosage forms...

Regulatory Pharmaceutical Compliance Consultant with Expertise in Clinical, Pharmacovigilance, Biologics, Biosimilars, Orphan Drug, Medical Device, Natural Health Product, Dietary Supplement, Cosmetic, and Food.Regulatory strategy, pathways and gap analyses.Regulatory submissions and applications for diverse product types to global regulatory agencies: Health Canada, US FDA and EU EMA (CTA, IND, IDE, DMF, NDS, SNDS, ANDS, SANDS, DIN, NDA, NDA 505(b)(2), BLA, ANDA, PAS, CBE, CBE-30, 510(k), PMA, HUD, HDE, Class II, III and IV Device License Applications, ITA, MAA, Type I and II variations, Technical File, PLA, Amendments, Notifications, a...

Pharmaceutical Regulatory Consultant with Broad SNDA, GMP, API Development Experience.Development of commercial manufacturing, FDA and international registration and approval for atracurium besylate, trifluoridine, bupropion hydrochloride, zidovudine, exosurf, mivacurium chloride, doxacurium chloride, pseudoephedrine hydrochloride, acrivastine, valciclovir, tramadol hydrochloride, topiramate, levofloxacin, surfaxin, vinorelbine tartrate and lamotrigine.Major process SNDAs for ofloxacin and leucovorin calcium.Regulatory documentation and approvals (FDA request for NDAs for grandfathered products) for digoxin, melphalan, azathioprine, thiogu...

Analytical Chemistry Consultant Specializing in Lean cGMP Laboratories Operations, Methods Validation and Transfer, Quality Control Testing, OOS and Nonconformance Investigations for Regulatory and Manufacturing in Pharmaceutical and BiotechnologyAnalytical, biochemical, microbiological, and raw material cGMP testing laboratories.Implementation of robust quality systems including, test method validation and transfer, Out Of Specification (OOS) investigations, product stability program, LIMS, training program, document control, specifications, equipment qualification, raw material qualification, risk assessment, Corrective And Preventive Ac...

Radiopharmaceutical Consultant Specific To: QA, QC, GMP, GMP internal Audits, Health Canada GMP Inspections and ExpertRadiopharmaceutical industry experience ranging from, Quality Assurance, (QA) Quality Control (QC), Good Manufacturing Practice (GMP), GMP internal audits, Health Canada GMP inspections, deviation handling and implementation of Corrective and Preventative Action (CAPA), change controls stability program, and validation. Oversee fast-paced radiopharmacy production environment. Quality Assurance Manager, applying over15 years of global experience in the radiopharmaceuticals industry. Demonstrated extensive and consistent...

Medical Devise Regulatory Affairs - Audits: ISO 13485, cGMP Part 211, Due Diligence, GCP, (QSIT), (QSR), CAPA , Failure Investigations, FDA- 483 (OOS), SOP, IDE and PMA,Over 30 years of experience in FDA regulated industries.FDA regulatory affairs, quality assurance, and compliance with expert skills in good manufacturing practices and good clinical practices for both the pharmaceutical and medical device industry.Clinical trials for CRO and Phase III trial for a cardiovascular drug.Medical device monitoring studies and site qualification for: Carbon dioxide injector (used by interventional radiologists); angiographic studies of the...

Biological Manufacturing: Auditing, Root Cause Analysis, Corrective, Preventative Action and GxP compliance. Biological and clinical manufacturing operations executive, providing a wide range of experience in quality leadership across many facets. Create, develop and recommend program and system changes pertaining to vaccine product release and deviation management resulting in more efficient product release to market and improved "right-first-time" manufacturing metric. Articulate leader with unparalleled work ethic coupled with a strong sense of urgency, keen interest and passion in making quality a key ingredient to the success of...

Commissioning and Qualification of Solid Oral Dosage Facilities, Operation Excellence in Supply Chain, Drug Master Files Review, Validation of Analytic Control, Implement EHS Management Systems Quality management system: Design, Standard Operating Procedures (SOP) training, auditing, upgrading quality systems. Design of oral dosage manufacturing processes. Design of manufacturing process and equipment’s User Requirement Specification (URS). Commissioning and qualification of process equipment, clean rooms, HVAC, and purified water system. Market research, business plan, product targeting. Regulatory affairs: Review of parts 1...

Specialty Chemicals & Pharmaceutical Supply Chain-Change Agent, Regulatory, EPA, OSHA-PSM and Global Manufacturing ExpertPharmaceutical and specialty chemical operations with 20 years’ in supply chain Leadership for large facilities, providing technical solutions in challenging environments in union and non-union members. Manufacturing and operations professional, action-oriented, building effective teams and delivering positive results with unlimited drive for continuous improvement in fast paced, global businesses. Change agent and transformative leader in global manufacturing footprints leading to increased efficiency and throughp...