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Toll free: +1-800-447-9407 support@gcplearning.com Cart 0 items GCPlearning Sign In Sign Up * Home (current) * Virtual Seminars * Webinars Live Webinars Recorded Webinars Recorded Webinars ($10) * Consulting * Membership Join/Renew Benefits Package/Plans * Blog * Past Seminar Pictures SPEAKER PROFILE Carolyn Troiano Consultant, BrainStorm Central Consulting Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation. * Upcoming Virtual Seminars * Recorded Virtual Seminars * Recorded Webinars * Thursday, 25. Januar 2024 * 08:00 AM PST | 11:00 AM EST, * Duration: 4 Hours * 445,00 € 4-HOUR VIRTUAL SEMINAR ON FDA TRENDS FOR COMPUTER SYSTEM VALIDATION (CSV) COMPLIANCE AND ENFORCEMENT Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. View Details * Recorded * View Anytime * Duration: 6 Hours * 595,00 € 6-HOUR VIRTUAL SEMINAR ON 21 CFR PART 11 COMPLIANCE FOR COMPUTER SYSTEMS REGULATED BY FDA The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. View Details * Recorded * View Anytime * Duration: 6 Hours * 595,00 € 6-HOUR VIRTUAL SEMINAR ON FDA TRENDS FOR COMPUTER SYSTEM VALIDATION (CSV) COMPLIANCE AND ENFORCEMENT This webinar will focus on the key areas that are most important for protecting the validity of data that is regulated by FDA, and is typically housed electronically in computer systems. View Details * Recorded * View Anytime * Duration: 6 Hours * 595,00 € 6-HOUR VIRTUAL SEMINAR ON 21 CFR PART 11 COMPLIANCE FOR COMPUTER SYSTEMS REGULATED BY FDA The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability View Details * Recorded * View Anytime * Duration: 6 Hours * 595,00 € 6-HOUR VIRTUAL SEMINAR ON FDA TRENDS FOR COMPUTER SYSTEM VALIDATION (CSV) COMPLIANCE AND ENFORCEMENT This webinar will focus on the key areas that are most important for protecting the validity of data that is regulated by FDA, and is typically housed electronically in computer systems. View Details More * Recorded * View Anytime * 190,00 € COMPUTER SYSTEM VALIDATION (CSV) AND SOFTWARE TESTING: APPLYING AN AGILE METHODOLOGY VS. WATERFALL FOR FDA-REGULATED COMPUTER SYSTEMS AND SOFTWARE Advancements in technology have forced organizations to rethink business models. View Details * Recorded * View Anytime * 190,00 € COMPUTER SYSTEM VALIDATION (CSV) FOR FDA-REGULATED COMPUTERS The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines. View Details * Recorded * View Anytime * 190,00 € 21 CFR PART 11 (ELECTRONIC RECORDS/SIGNATURES) COMPLIANCE FOR COMPUTER SYSTEMS REGULATED BY FDA There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. View Details * Recorded * View Anytime * 190,00 € COMPUTER SYSTEM VALIDATION (CSV) FOR FDA-REGULATED COMPUTERS The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines. View Details More SIGN UP FOR OUR NEWSLETTER Subscribe QUICK LINKS * About Us * FAQ * Support * Contact Us * Become our Speaker QUICK LINKS * Terms & Conditions * Privacy Policy * Legal Disclaimer * Unsubscribe SAFE & SECURE CONTACT US GCPlearning NetZealous LLC, 39658 Mission Boulevard, Fremont, CA 94539, USA Phone: +1-800-447-9407 Fax: 302 288 6884 * * * -------------------------------------------------------------------------------- Copyright © 2024 GCPlearning.com. All rights reserved.