Auditing for 21 CFR Part 11

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Description:

This seminar will discuss the basics of Part 11 requirements and practical techniques for evaluation of the current compliance status of a given organization. You will hear about validation plans, user requirements, test plans, test reports, change controls, standard operating procedures, data backup and business continuity. Case studies will be used to highlight common issues and potential solutions.

21 CFR Part 11 provides the basic framework for computer systems used to generate records and data used for analysis and presentation. Validated computerized systems are integral for producing accurate, reliable and consistent data. For many small to mid-sized organizations, meeting the regulatory requirements is a daunting task and Part 11 compliance is a major focus for audits. In this seminar, we will simplify the Part 11 requirements and provide practical tips in assessing computerized systems that will have you ready for your next audit

Areas to be Covered:

Part 11 requirements by FDA
Validation of computer systems – Validation Plans, Requirements, Specifications, and Test Reports
Recommended SOPS
Change control
Data backup and business continuity
Compliance Assessment
Planning, preparing and executing audits
Common audit findings and tips for a successful audit

Who will Benefit:

This webinar will provide valuable information to:
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

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.

This product is currently out of stock and unavailable.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • 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