Are you prepared for your first/next FDA inspection (audit)? Whether an FDA audit is being performed as routine or for cause, it is inevitable that every site will face audits over the course of their research. This webinar will present information to help research sites prepare for an FDA inspection.
Key topics that will be covered include:
About the Presenters:
Madeleine Williams, MA, CIP, is a Senior Director in Huron’s Education practice. Maddie has over 12 years of research experience and her specific areas of experience include the management of engagements focused on clinical research compliance, research project management and Institutional Review Board (IRB) operations structure and function. Maddie’s focus is on helping organizations to improve their processes, enhance research compliance and improve efficiency.
Roberta Costello, MSN, RN has been working in clinical research in an academic hospital for about 20 years and is currently the Research Compliance Officer (RCO) for Albert Einstein Healthcare Network. In this role, Roberta serves as a support resource for researchers providing information related to compliance, auditing, and education. Roberta also has previous experience working as a research coordinator and project manager.