Shane is a motivated Quality Assurance and Operations expert with more than 20 years combined experience working in regulated industries (FDA and DEA) and is a certified quality engineer (CQE) and Risk Assessment Black Belt. He is the Vice President of XFDA Investigators, LLC and also serves as Business Management Services Director. Shane served in the United States Marine Corps and managed the QA/QE aviation electronics & validation systems at Air Station Miramar in San Diego assuring compliance with applicable government standards. He has worked with both pharmaceutical and medical device manufacturing companies as VP of Quality; Director of Operations; Quality Engineer (SME); QA/Compliance Manager and as a compliance consultant regarding quality systems, remediation efforts, and due diligence audits for clients. He also conducts GMP/QSIT/DEA compliance audits for pharmaceuticals and medical devices. He has expertise with DEA regulated products and DEA State registrations.
His expertise covers a broad range of quality and manufacturing systems such as Project Management, Technical Engineering, Validation, Production and Process Controls (P&PC), Electrical and Mechanical Failure Analysis, CAPA, Lean Six Sigma Manufacturing, and expertise in writing and remediating NCMRs/Deviation Investigations and CAPA based on Risk Management/trend analysis. Shane earned an MBA in Global Management, Ashford University and a Bachelor’s degree in Business Management (SDSU).
Deena has more than 25 years experience in the pharmaceutical and medical device regulated industries. Her expertise is in many areas most notably Project Management; Computer System Validation; LIMS validation; Operations Management; GMP’s; Compliance and Laboratory auditing (GAP Assessments); Investigational skills; and Change control management systems.
She is highly experienced in working highly stressful back rooms during FDA audits and mentoring individuals involved during the audit. She directs and designs compliance initiatives (CAP-Corrective Action Plans) to remediate quality systems for Executive Management and provides oversight during implementation.
Deena speaks fluent German and holds an MBA in Pharmaceutical Chemical studies from Fairleigh Dickinson University, Teaneck, NJ; and a Bachelor of Science in Biochemistry , Upsala College, East Orange, NJ.
Gregory Jean-Noel, MD, MBA has many years of pharmaceutical industry experience in monitoring quality control, responding to medical inquiries from patients/pharmacists, participating in research and development activities, and responding to FDA regulatory inquiries and investigations. He has held positions as Clinical Medical Director and Project Manager responsible for over-seeing projects from product development through FDA submission. Gregory also provides Risk Assessments regarding complaints and early developmental activities. He is a certified designated representative and has extensive knowledge of federal regulations (GMPs/DEA).
Gregory holds a Bachelor of Science degree in Chemistry from Xavier University, a Medical Degree from CAHSU, and an MBA from Davenport University.
Robert has more than 30 years industry experience with all phases of clinical trials with both pharmaceutical & medical devices. He performs mock-FDA audits for GCP, GXP and GLP areas; as well as conducts GMP Gap assessments and also has expertise in Project Management.
Robert has participated in numerous remediation activities helping firm’s to achieve compliance with Clinical research federal requirements as well as Good Manufacturing Practices. He has extensive experience in conducting international audits as well as domestic audits.
Robert has published articles in Thrombosis Research 42; p789-796, 1988. He holds a Master’s Degree in Business Management from California State, Carson CA and a B.S in Biology from Loyola Marymount University, Los Angeles, CA.
Jaclyn has 10 years experience working in the pharmaceutical and medical device industries. She has participated on many projects working with remediation of the complaint system, change controls, APRs, review of batch records, product release and document control activities. She also provides support to other consultants working with XFDA Investigators.