Clinical System Data Management Validation

Duration: 75 Minutes
Have you validated your clinical data base? Do you have the proper documentation in the event of a regulatory inspection? In this course we will cover considerations and requirements for validation of clinical data management systems. We will discuss the challenges and strategies of risk based validation and review 21 CFR Part 11 expectations. We will discuss the importance of a change control process.
Clinical System Data Management Validation
Instructor: Susan Leister
Product ID: 501926
Validation can be a confusing topic as more systems are becoming Software as a Service (SaaS) and we will cover what the requirements are for the various types of software systems from SaaS, COTS, MOTs, and custom built systems. Best practices to system validation will be discussed for clinical data systems as well as study specific validation.

Objectives of the Presentation
  • Review the basic requirements of 21 CFR Part 11
  • Examine the steps in a risk-based approach to validation
  • Discuss challenges encountered in software validation
  • Discuss the importance of a change control process
  • Identify best practices in validating a study specific application
  • Discuss the different types of software systems
Why Should you Attend
During this training session, attendees will expand their understanding of clinical data management system validation and study specific validation. There are many options available today for clinical data systems, varying from SaaS to custom built. We will discuss the challenges associated with making a major change to a clinical database and how to manage the change control process. In addition requirements following 21CFR Part 11 for validation will be discussed. At the end of the webinar, you will understand the differences in the various software options available and how this impacts the validation requirements from a risk based perspective.

Areas Covered
  • Risk based software validation
  • Requirements of 21 CFR Part 11
  • Change control process
  • Validation requirements for different types of systems
  • Best practices in validating a study specific application
  • Challenges encountered in software validation
Who will Benefit
  • Clinical Data Management Staff
  • Quality Assurance/Quality Control Managers
  • Regulatory/Compliance Staff
  • IT Staff
  • Software Validation Staff
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • 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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