Electronic Records Compliance: A Risk-Based, Predicate Rule Approach
Course Description
Although FDA continues to examine 21 CFR Part 11, electronic records compliance remains as critical as ever. Why? Because the predicate rules (any FDA regulation or law that includes a requirement to keep a record) still apply! In fact, no matter what happens to Part 11, companies need to ensure the reliability and trustworthiness of electronic records. This course shows you how to achieve this goal. Topics include the applicability of predicate rules to electronic records; how to apply a risk-based approach to electronic records compliance; risk analysis techniques; computer system validation; GAMP® challenges associated with common computerized systems; electronic signatures; the current and future status of Part 11; and more. By the end of this two-day training course, participants have the skills and knowledge necessary to ensure e-records comply with predicate rules and 21 CFR Part 11.GAMP® is a registered trademark of ISPE. Please visit www.ispe.org for more information.
Booking Options
This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com.