Audit program (Internal & External ) for Clinical trial sites

Duration: 120 Minutes
Making sure your clinical staff are prepared for audits is essential. This session will help prepare clinical site staff for internal and external audits. We will discuss audit preparation strategies; discuss the benefits for internal audits, and how to be inspection ready. Sponsor audits and vendor audits can also occur so having all staff ready in advance for interviews and document retrieval is important to ensure a successful outcome.
Instructor: Susan Leister
Product ID: 501076
Objectives of the Presentation
  • Review the overall purpose of auditing for clinical trials
  • Discuss internal audit program for clinical sites
  • Discuss how to manage internal audits
  • Discuss how to manage external audits (sponsor/client)
  • Discuss how to manage regulatory inspections
  • Discuss inspection readiness approach
Why Should you Attend
Audits can be unpredictable, especially external audits. This is the benefit of having an internal audit program. We will review best practices for an internal audit program and how to prepare for internal audits. In addition, we will discuss how to manage external audits. It is better to prepare then be surprised when the audit request occurs. Take the time now to plan and prepare while educating all of your staff on audit do's and don'ts. Lack of preparation can result in an unfavorable outcome.

Areas Covered
  • The purpose of having internal audits at clinical sites
  • Internal audit program at a clinical site
  • Managing and responding to an internal audit at a clinical site
  • Managing an external audit at a clinical site (Sponsor or a client)
  • Managing a regulatory inspection
  • Inspection readiness approach
Who can Benefit
  • Clinical Quality Staff
  • Regulatory Staff
  • Clinical Study Coordinators
  • Monitors
  • Clinical Trial Support Staff
$300
Recorded Session for one participant
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Live Session - How it works
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  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr. Susan Leister serves as the director of quality assurance at Technical Resources International Inc. with over 20 years of experience in the pharmaceutical and medical device industry. She has validated over 40 software systems in the past few years and is very fluent in software validation requirements and compliance. She is also faculty for both graduate and undergraduate studies at the University of Phoenix. In addition to a bachelor's degree in biochemistry and molecular biology, she has an MBA, a doctorate in organizational management with a focus on leadership, and holds certifications from the American Society of Quality (ASQ) as a Certified Quality Auditor and a Six Sigma Black Belt.Dr. Leister has broad experience in GCP, GLP, and cGMP. She serves the ASQ Section 509 Executive Committee as the chair-elect and has been serving for the past four years as a Maryland Performance Excellence Award Examiner.
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