Robustly Responding to Regulatory Inspection Observations

Learning Objectives:
• Reference response options for key tissue banking regulatory bodies (AATB, FDA, ISO, etc.).
• Clearly outline immediate corrections and containment actions necessary to mitigate the risk of further/escalated regulatory action (e.g., Warning Letter)
• Document and summarize CAPA activities to effectively prepare a sound and strategic response toward a favorable outcome with minimal risks.

Jennifer Wesbrook, BS, CTBS

Jennifer has been with AlloSource for 15 years and provides overall management and leadership to the Quality Control, Product Suitability & Release and Quality Management Systems departments. She and her team support the development and implementation of quality improvement initiatives and Design Control (New Product Development) at AlloSource. Under her leadership, AlloSource has developed a robust Quality infrastructure using evidence based best practices to mitigate risk and resolve process deficiencies. Jennifer is AlloSource's Management Representative and acts as liaison with the FDA, ISO, AATB and other regulatory authorities, as well as customers.