Current FDA Trends in Inspection and Enforcement Related to Regulated Computer Systems
In this webinar join expert speaker Carolyn Troiano, where she will cover the key aspects of complying with 21 CFR Part 11 in both validating systems and maintaining them in a validated state throughout their entire life cycle.
The 90-minute webinar will be conducted by Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, computer system validation and large-scale IT system implementation projects. Carolyn participated in the Industry/FDA partnership that developed 21 CFR Part 11, the FDA’s guidance on electronic records and electronic signatures (ER/ES).
Webinar attendees will learn:
•The most proactive methods for getting ahead of the curve and avoiding computer system validation pitfalls
•Understand Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
•Learn how to document CSV efforts related to “GxP” systems – Good Manufacturing, Laboratory and Clinical Practices (GMPs, GLPs, GCPs)
•Learn about 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES) Documentation
•Understand Data Archival to ensure security, integrity and compliance
•Understand how to effectively document the process of computer system validation, and maintain current information about the systems in your organization and how they are maintained in a validated state
Edupliance is an online information provider which offers webinars (Live and On-Demand), DVD’s and downloadable resources that cover concurrent topics pertaining to various industries. With an expert panel of guest speakers, Edupliance brings state-of-the-art virtual technology solutions and industry-leading training sessions that are easy to learn, easily accessible and cater to people with varied interests. Edupliance is privately held and located in Hillsboro, Oregon.
For more information, visit www.edupliance.com.
T: 1 – 844-810-1151
A:- Edupliance - #101, 4660, NE Belknap Court, Hillsboro, OR 97124 |
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