Whether it is For-Cause or Routine, audits are stressful events. This webinar will describe what to expect from an audit. The webinar will begin with the notification of an audit. Then, teach you how to prepare for an audit and what to do during the audit. The webinar will discuss how to develop an audit plan and checklists to prepare for the audit. Once the audit has begun, we will examine good practices for the conduct of an audit. Finally, the webinar will discuss the outcome of the audit and how to respond to the audit.
What You’ll Learn
Attendees will be able to:
1. Define the different types of audits.
2. Describe how to respond to the notification of an audit.
3. Explain how to prepare for an audit.
4. Describe how to conduct the audit.
5. Explain how to respond to the audit.
Participants will understand how to respond to an audit. Specifically, they will understand how to deal with the audit notification, audit preparation, audit conduct and respond to the audit results.
Pat Beersblock works part time as an Adjunct Assistant Professor for the University of Medicine and Dentistry of New Jersey, School of Health Professions, Department of Health Informatics, developing and presenting courses for the School’s Masters degree program in Clinical Trials (2010-present). From February 2010-12, Pat served as Vice President of Regulatory Policy within the Regulatory Compliance Team at Medidata Solutions Worldwide. Prior to joining Medidata, Pat held increasingly more responsible positions during her 33 year career with the U.S. Food and Drug Administration. During her tenure with FDA, Pat acquired extensive knowledge of the regulations, policies, inspectional program, and regulatory review process governing investigational drugs.
Who Should Attend
Intermediate to advanced CDMs, CRAs and biostatisticians.
Participants are eligible to receive CEUs upon attendance and succesful completion of a web-based assesment within 30 days after the webinar. CEUs are not granted after the 30-day assesment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.