Part 11 Compliance and the Role of Standard Operating Procedures

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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. In this seminar, 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.

This seminar 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.

Areas to be Covered:

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 will 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

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. 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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  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance