A recognized quality, compliance and regulatory expert with first-hand experience of obtaining FDA approvals for new product and processes for the Life Sciences including Biologics, Pharmaceutical and Medical Devices & IVD. Experienced negotiator with the US FDA for product approvals, compliance, and regulatory issues.Certified Quality Engineer with 30 years of experience in all phases of new product development, manufacture, and introduction of pharmaceutical, biopharmaceutical and medical device products.Lead Assessor and performance auditor in all areas of medical devices, biologics, and pharmaceutical regulations. Expert in Systems-Based inspections for Drug Manufacturers, Quality System Inspection Technique for Medical Devices and Good Tissue Practices (21 CFR Part 1271).Successful in preparing firms for a FDA inspection, responding to FDA-483, initiating a Corrective Action Master Plan. Implemented strategic corporate quality systems, which complied with the appropriate US FDA regulations and requirementsMicrobiology-trained with a strong knowledge of aseptic processing, microbiological assays, environmental control practices, and validation of sterilization methodsExcellent communication skills. Presenter at several FDA/Industry conferences and webinars. Expert Witness for legal casesSpecialties: Audits-Certification/Due Diligence/GLP/GMP/ Device and Drug Quality Systems, CAPA, Design, Controls, Environmental Monitoring, Failure Investigations, FDA - 483 and Warning Letter responses, ISO, ISO 13485:2003., Out-of-Specification (OOS) Investigations, Quality Assurance/Control/Management/Systems Development/Implementation, Regulatory Affairs, Regulatory Strategy Consulting, SOP Development, Stability Programs, Submissions-510(k)/Combination Products/IDE/PMA/IND/NDA, Training
Listed skills include Fda, Capa, Validation, Gmp, and 16 others.
