FDA is increasing emphasis on scrutiny of computer systems validation and adherence of 21 CFR part 11 compliance validation to companies under FDA regulatory jurisdiction. A third of FDA’s recent warning letters have been with respect to improper or ineffective QA validation practices. Increasing use of automated manufacturing and quality system is forcing exposure of computer systems. 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 21 CFR Part 11 compliance is a major focus for audits.

This seminar will discuss the basics of 21 CFR Part 11 requirements and practical techniques for evaluation of the current compliance status of a given organization. You will hear about QA 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. We will ensure your readiness for 21 CFR Part 11 compliance to confidently face the next FDA compliance audit.