Abha Kharbanda - ASQ CQA

Responsible for the overall quality management of a Phase I/IIA clinical research center (CRC) operated by Frontage Clinical Services, Inc. (FCS).

Plan, manage and perform GCP audits of Contract Research Organizations (CROs), systems/processes and clinical Investigator sites for Phase I to III clinical trials Prepare audit reports and communicate findings to auditees, study team representatives and management Review and assess audit report responses and ensure that corrective and preventative action (CAPA) plans adequately address findings and root cause analysis. Evaluate, track and follow up on CAPAs to ensure actions are adequately completed in a timely manner. Lead completion of audit follow-up activities Review/assess protocol deviations with clinical operations. Review of risk and issue logs. Lead in the planning of regulatory GCP inspections. Developed and reviewed company’s clinical quality SOPs, IR guidelines and tools. Assess inspection readiness and developed Inspection Readiness trainings for cross-functional team members. Lead the efforts in preparation for Site Inspections and Sponsor/CRO Inspections. Participate in regular study team meetings and provide quality oversight and consultation at program/study level Provide risk identification/mitigation support for potential and/or identified quality issues Evaluate audit finding trends and other information sources to support audit planning and optimize clinical trial quality and compliance Identified Sites of Interest based on BIMO listings and regulatory correspondence; prepare the sites for FDA inspection and staging documentation. Provide GCP compliance consultation on process enhancement & quality issue management. Appropriately escalate quality/compliance issues to management Maintain current industry knowledge of applicable regulations, guidelines, and company standards Evaluate impact of new regulations/guidance, as well as audit results/trends on the business Travel up to 30%

Defines and ensure in the execution of the strategies with cross functional departments to build inspection readiness, identify and mitigate clinical quality risk. Worked on performance metrics and dashboards for status of inspection readiness and preparation. Provided visibility of project level clinical quality risks to management. Provided back-room Quality function support during regulatory agency inspection. Ensured study and administrative documentation is quality controlled, available and study team is able to withstand the scrutiny of the BIMO inspection. Responsible in completion of PAI Preparation reporting tools (Frequently Requested Document Tracker, In-Process Control, PAI Activity Trackers, etc.) Ensure Clinical Trials are performing according to necessary ICH/GCP and relevant regulatory requirements, global departmental and geographical SOPs, policies and guidelines. Support study specific Inspection preparation activities of Mock sessions, front room and back room set up, system access to inspectors and identify functional SME Contributed to gather, analyze & prepare lessons learned/best practices, in collaboration with relevant stakeholders. Contributing to deliverables for Clinical Quality Risk Management, Clinical Quality Documents & Process, Clinical Training, and Clinical Quality Assessment. Maintained tracking of quality risk and gaps found during IR activities. Assisted in Inspection Readiness and Preparation Plans and Inspection Readiness Staging Plan with respective clinical study team leaders, co-development partners and CROs. Update & reformat of CQA/CIR Toolkit (participate in the cross functional review team). Consolidation & Improvement of current quality tools with a focus on automation Provide compliance consultation as per regulatory compliance manual as needed. Responsible to liaison with IT in updates to departmental SharePoint and Intranet

Work with cross functional team for quality review of regulatory documentation of trials. Support qualification audits, interim GCP audits of service provider and investigator sites audit documentation of study requirements, protocol adherence, risks, AE/SAE records etc. Participate in planning, and correspondence of site audits to external auditors, provide access to study specific protocol and systems and manage SharePoint and eQUTE. Manage trackers and logs of clinical study audit program – selection, preparation, conducting, reporting, CAPA follow up. Updated audit checklists and QA SOPs, per regulatory requirements change Coordinate with the study team with deliverables, visit agendas, confirm Audit dates. Ensure completion of suspected GCP non-compliance documents forms, supportive and reported documents, correspondence, uploads and follow ups. Coordinated with key members for responses to FDA Form 483, and CAPA Implementation and evidence and maintenance of the documentation. Support and review contracts of vendors, their WO, PO, invoices and budgets for QA GCP function.