Part 11 Compliance and the Role of Standard Operating Procedures

Duration: 60 Minutes
21 CFR Part 11 describes the quality standards required of all computer systems used in FDA-regulated industry. This regulation provides the basic framework for computer systems used to generate records and data used for analysis and presentation. However, it is important to remember that not only are technical controls but there are procedural controls as well.
Part 11 Requirements
Instructor: Herman Wong
Product ID: 500116
In this webinar, we will simplify the regulatory requirements and provide practical tips in creating standard operating procedures that will have you ready for your next audit. We will also provide you with helpful tips when purchasing commercial off-the-shelf (COTS) software.

Why Should you Attend:
This webinar will discuss the basics of Part 11 requirements and needed procedural controls to maintain compliance. You will hear about validation requirements, system security protocols, access control, data backup, recovery and contingency plans, as well as change control. Case studies will be used to highlight common issues and potential solutions.

Objectives of the Presentation:
  • Review the key 21 CFR Part 11 requirements
  • Standard Operating Procedures for computer systems
  • Validation of computer systems
  • Tips when purchasing COTS software
  • Common audit findings and tips for a successful audit
Who can Benefit:
This webinar will provide valuable information to:
  • Clinical trial sites, manufacturers, and sponsors
  • Everyone involved in computer system validation
  • Anyone selecting computer systems intended for FDA regulated environments
  • Information technology professionals responsible for files or network locations
  • Quality professionals who organize, document and verify system compliance
  • Executives evaluating requirements Part 11 compliant systems
Live Session - How it works
  • We will send Username and password 24 hours prior to webinar at your email address.
  • Webinar presentation handouts will be shared in pdf format, a day before live presentation.
  • Use the login details to participate in sessions.
  • Clear out your queries through interactive Q&A chat boxes with the speaker.
  • We need to know your experience, so please don't skip to provide us with your overall presentation feedback.
  • Get certification of attendance.
Recorded Session - How it works
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  • Use the login details to view recorded webinars.
  • Presentation handouts will also be shared in pdf format.
  • Access to the recording is valid only till 6 months starting from the date of purchase.
  • Get certification of attendance.
$375
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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:
Herman Wong is a Washington DC-based consultant for computer systems in FDA-regulated industry. He has been in the industry for over 12 years and is the Director of the Information Technology department at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in training of IT personnel in FDA-regulated industry, creating, managing and implementing Part 11 compliant computer systems. Since 2005, Mr. Wong has been evaluating EDC systems for Part 11 compliance at small and big organizations including some of the largest US federal organizations and large pharmaceutical companies.
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