Director :
Carolyn Troiano
Date: | February 4th & 5th, 2019 |
Time: | 8:00 AM to 5:00 PM |
Location: | Boston, MA |
Venue: | Four Points by Sheraton Boston Logan Airport Revere, MA |
Download: | Seminar Brochure |
Lecture 1:
Introduction to the FDA (1:30) {1:30}
Lecture 2:
21 CFR Part 11/Annex 11 - Compliance for Electronic Records and Signatures (4:00) {5:30}
Lecture 3:
The Five Keys to COTS Computer System Validation (0:30) {6:30}
Lecture 4:
The Validation Team (0:30) {7:00}
Lecture 5:
Ten-Step Process for COTS Risk-Based Computer System Validation (1:00) {1:00}
Lecture 6:
How to Write Requirements and Specifications (0:30) {1:30}
Lecture 7:
How to Conduct a Hazard Analysis/Risk Assessment-Exercise (0:30) {2:00}
Lecture 8:
Software Testing (1:00) {3:00}
Lecture 9:
System Change Control (0:30) {3:30}
Lecture 10:
Purchasing COTS Software (0:30) {4:00}
Lecture 11:
Cost Reduction Without Increasing Regulatory or Business Risk (1:00) {5:00}
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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.