Software Validation and Quality Consultant for FDA ComplianceAuditing for ISO 13485, FDA QSR, ISO 9001, MDD and IVD, CE mark.Specialist on FDA regulated industries and software validation requirments.Process validation, software validation, Part 11, GMP development, ISO 13485 development.FDA response and remedial actions, quality systems creation, quality systems improvement.Creation of technical course and leading training groups on FDA-QSR and Software Quality, including training effectiveness assessments.FDA quality documentation, risk management, specification development and sampling plan analysis and rationale.

Consultant for Biopharmaceutical Process Development, Operations and cGMP CertificationOver thirteen years in the life science industry with more than ten years of downstream process development, technology transfer and cGMP experience for combined biopharmaceutical, in vitro diagnostics and medical device industry.In depth experience in finding and implementing practical solutions to both midstream and downstream processes.Four years of hands on experience working in the clean room environment, witnessing and troubleshooting the processes, data analysis and quality oversight within a highly regulated cGMP manufacturing environment.Four ye...

GMP Biochemistry Consultant and Laboratory Manager in CanadaOver fourteen years in the Canadian life science industry specifically in biopharmaceutical GMP development and manufacturing.Directed major operational departments including quality assurance, quality control, validation, operations, process development and project management.For start-up company established operational departments, internal business systems, annual budgeting, personnel management and mentoring, contract estimation, contract negotiation, contract management and quality oversight, all within the highly regulated GMP manufacturing environment.CMC commercial portfo...

Industrial chemist with extensive experience in Medicinal Chemistry, Drug Discovery, Organic Synthesis, Technical Writing, cGMP, Chemical Hygiene and Lab Safety, and EPA & OSHA ComplianceMedicinal chemistry, process research and development, and organic synthesis.Drug discovery, including small molecule structure-based design and SAR optimization in collaboration with CADD, biology, ADMET, and informatics teams.Design and synthesis of complex organic compounds for medicinal applications.Rational, structure-based drug design and development.Design and execution of optimized, scalable, safe chemical processes for drug intermediates and APIs...

Drug Quality and Compliance Expert in Analytical Chemistry, Drug Stability, Out of Specification Investigation, Manufacturing Change Control and cGMPSummaryPharmaceutical quality and compliance, analytical method development and validation.Interpretation of changing regulations.Thirteen years of pharmaceutical industry experience operating within both GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices) environments that included eight years of pharmaceutical research and development, hands on technical and research experience, in analytical method development, validation, and application and five years of technical and...

Aerosol Expert for Performance Studies and Regulatory Agency Compliance, Including Quality Assurance of OTC Drug Products.Aerosol issues (troubleshooting, clogs, leaks, failures) and aerosol performance studies.Quality assurance, control and regulatory with experience in manufacturing OTC drug products.Communication and compliance with FDA, EPA, CARB.Developing new systems capable of tracking location and status of all components, raw materials, and finished goods while product is in operation.Undisclosed Company, Quali...

MD with expertise in neurosciences and brain imaging, with extensive experience in medicine, clinical research and analysis including GCP regulations and specializing in clinical neurology, radiology and pathologyA practicing Medical Doctor with 10 years of experience in neurosciences, five years in nuclear medicine, and one year in molecular biology and pathology.Assessments of brain trauma patients, disability cases, for the insurance industry.Extensive experience in data analysis of PET, SPECT MRI, fMRI, and EEG with source localization.Extensive experience in medicine, clinical research and analysis including GCP regulations, specializ...

Medical Device Design and Product Development Expert Specializing in Class III and Class IIb Devices (Coronary and Peripheral Bare Metal Nitinol, SS, Cobalt Chromium and Drug Eluting Stents and Balloons, Scoring Balloon Catheters, Vascular Grafts, Hemodialyzers)Medical device design, product development and commercialization experience of 21 years with a record of building and leading high performance product development teams, developing and commercializing new products, and driving increased revenues and profitability.Successful track record in large (Medtronic, Baxter) and start-up (AVE, AngioScore, NanoVasc) corporations.Research, prod...

GMP, ISO Quality, Compliance, and Audit Expert for Pharmaceutical and Medical DevicesGMP and ISO matters relating to quality control and quality assurance in the medical device, dietary supplement and pharmaceutical industries.Good Manufacturing Practices (GMP), and ISO Certified Lead Auditor.Document control, training, supplier and quality assurance.Auditing, document control, training, supplier and contract quality assurance.Process validation and contractor managementQuality control and quality assurance for a facility producing tablets, aerosols, suppositories, time-release capsules, medical devices and small volume parenterals. Inject...

Small Molecule Drug Development and Manufacturing Expert with Extensive Biotechnology ExperienceSummaryDrug development from proof-of-concept to commercialization in early to mid stage biotech and large pharmaceutical companies.Extensive background in biotechnology and small molecule development, manufacturing, quality, analytical, regulatory, outsourcing, project management and business development. ServicesMarketed products: Biotech Products: Remicade (infliximab), Simponi (golimumab), Retavase (reteplase), Eprex (epoetin), ReoPro. Small Molecule: Patanol, Azopt and Volfenol%uFFFF.Development drugs: Large molecules: AntiIL5, AntiTNF,...