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POST ID: 5265

Webinar On - Auditing for 21 CFR Part 11

Region: Canada
Location: 5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Ca


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 Covered in the Session :
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

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