Athena Visel, Pmp, Rqap-Gcp, Ccrp, Rd Email & Phone Number

• Evaluate company GCP processes and systems against applicable regulations (FDA, Health Canada, EMA, ISO, ICH, PMDA, etc.), SOPs and policies, and company business needs • Build, manage, and execute global pharmaceutical and medical device clinical trial audit programs (e.g. sites, trial master files (TMF), clinical databases, safety reporting, clinical study reports, systems, and vendors) • Facilitate implementation of electronic systems for clinical operations, such as clinical trial management systems, electronic source data capture systems (eSource), and electronic patient reported outcome systems (ePRO) • Audit computer systems validation and assess Part 11 compliance• Develop trial specific plans, such as Risk Management Plans and Quality Plans • Act as a quality assurance liaison between the client and the contract research organization to ensure quality oversight• Assist in the review of clinical study and regulatory documents (i.e., protocols, ICFs, final study reports, trial master file, etc.) for compliance to department SOPs, applicable regulations, and Good Clinical Practices (FDA, EMA, ISO, ICH, PMDA, etc.)• Provide inspection readiness preparation and management• Facilitate root cause analysis and corrective and preventive action (CAPA) planning• Create and provide training to GCP, regulatory expectations, and CAPA

Raleigh, North Carolina, Us

• Built and manage audit programs and served as Program Lead for global studies• Executed audits of pharmaceutical and device trials. Specific audit areas included: investigator sites, trial master files (TMF), clinical databases, safety reporting, clinical study reports, systems, and vendors• Consulted with companies to build and/or revise their clinical operations and quality systems• Conducted inspection readiness audits of sponsors and sites• Provided investigator sites and study personnel with training on good clinical practices (GCP), inspection readiness, corrective and preventative action, and process improvement• Hosted sponsor audits and assists in Regulatory Authority inspections• Served as a trainer and mentor to less experienced auditors

Bridgewater, Nj, Us

• Managed B&L’s global GCP audit schedule, which included comprehensive system, clinical trial service providers (GCP/GMP/GLP), and clinical investigator GCP audits. Duties included conducting audits and coordinating audits through consultant auditors (audit planning, conduct, report generation, and follow up on corrective action plans)• Led the development of B&L's clinical quality system through the utilization of Kaizen and GE Workout techniques • Evaluated company GCP processes and systems against applicable regulations/guidances (FDA, EU Directives, ISO, ICH, Pmda, etc.), SOPs and policies, and company business needs; provided direction and guidance for clinical trial compliance issues• Created/revised department SOPs, and provided quality assurance review and quality control for department SOPs; supported maintenance of document and records management system• Reviewed clinical study and regulatory documents (i.e., protocols, ICFs, subject material, clinical study reports, etc.) for compliance with applicable regulations/guidances (FDA, EU Directives, ISO, ICH, Pmda, etc.)• Developed and delivered training, including GCP and SOP training, to department personnel, clinical investigators, and monitors • Hosted FDA/Regulatory inspections• Participated in company-wide WorkSmart Events (modeled after GE Workout); trained facilitator and designer

Bridgewater, Nj, Us

• Responsible for conducting GCP/GMP/GLP quality system audits to determine the state of compliance relative to the corresponding quality system, and regulatory standards and requirements. Audit activity includes company suppliers (including contract research organizations and contract manufacturers), and internal company facilities and functional groups.• Issued audit reports to company sites/suppliers and respective business unit leaders discussing observations made, and opportunities for improvement. • Managed the audit response process.• Monitored company sites’ compliance to external regulatory bodies including ISO certification, FDA, Canadian Medical Devices Regulations (CMDR), European Medicines Agency (EMEA), and Pharmaceutical and Medical Device Agency (Pmda).• Contribute to the development and maintenance of internal quality systems in support of the quality audit processes.• Collaborated with sites and suppliers on Corrective and Preventative actions for observations made during both internal and external audits. Monitored timely implementation and completion, and verified effectiveness of these CAPAs.

92866 Issy Les Moulineaux Cedex 9, Fr

• Provided medical nutrition therapy to patients in acute, rehabilitation, out-patient, and long-term care settings.• Reviewed and audited clinical nutrition policies at over twenty health care facilities within the New York and New England territory to ensure compliance with all federal and state regulations, as well as company policies and procedures. • Established operating procedures, implemented quality improvements, and generated reports on compliance and corrective actions. Findings were communicated with the respective facility’s staff via direct meetings and written reports. • Assisted in managing state and accreditation inspections• Trained new employees on the facility’s operations, policies, and procedures.

• Provided medical nutrition therapy to patients in acute, rehabilitation, and long-term care settings.• Reviewed and audited clinical nutrition policies in the long-term care facility to ensure compliance with all federal and state regulations, as well as the facility's policies and procedures. • Assisted in establishing operating procedures, implemented quality improvements, and generated reports on compliance and corrective actions in the long-term care facility. • Assisted in managing state and accreditation inspections

M.Engr., Biomedical Engineering (Emphasis In Intellectual Property And Technology Transfer)

M.A., Nutrition Science

B.S., Mechanical Engineering