On-Demand Webinar: Is Your Site FDA Inspection-Ready?

Presented by Madeleine Williams and Roberta Costello

Webinar Details:

This webinar was originally recorded on June 10, 2015.

Duration: 60 minutes

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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:

  • Understanding what the FDA will be looking for during an audit
  • Common findings of FDA audits
  • Example questions from auditors and areas of focus
  • Case study

About the Presenters:

Madeleine Williams

Webinar Presenter

Madeleine Williams

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

Webinar Presenter

Roberta Costello

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.