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Carolyn Troiano

Carolyn Troiano is Keynote Speaker at Compliance key Inc.She has more than 30 years of experience during which she worked directly, or as a consultant, for many top-tier pharmaceutical, medical device and biological companies in the US and Europe. She was responsible for computer system validation compliance activities across all GxP functions at a major pharmaceutical company. She developed computer system validation programs and strategies and was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation.

Carolyn has participated in industry conferences, and is currently active in the AITP, and PMI chapters in the Richmond, VA area. Carolyn also volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.

 Webinar Id: LSHCT0008
10:00 AM PT | 01:00 PM ET
 Duration 90 mins

Integration of ERP and Legacy Computer Systems Regulated by FDA

We will discuss the importance of applying industry best practices when planning, executing and validating the integration of a legacy system with a business system, such as an ERP or similar type of enterprise or supply-chain automation system. These are commonly integrated in manufacturing companies that use large-scale, enterprise-wide solutions for automating the production, testing and distribution processes in pharmaceutical, biot........

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       Single Attendee
(Only for one Participant)
Multiple Attendee
( 2 - 5 Participants)
Corporate Attendee
( 6 - 10 Participants)
(6 months unlimited access)
 Webinar Id: LSHCCT0001
 View Anytime
 Duration 90 mins

Data Governance for Computer Systems Regulated by FDA

Effective and compliant computer system data management is critical to organisations in the pharmaceutical, biologic, vaccines, tobacco, animal health, medical device or other FDA-regulated industry. During the past 30 years, best practices have been developed to ensure computer systems used in these environments can be cost-effectively managed while meeting all aspects of FDA compliance. To take this a step further, we are now looking ........

$237 Recorded (6 months unlimited access)
 Webinar Id: LSHCCT003
 View Anytime
 Duration 90 mins

FDA Compliance and Laboratory Computer System Validation

You should attend this seminar if you are responsible for planning, executing or managing the validation of laboratory computer systems governed by FDA regulations. Effective and compliant computer system validation is critical to any FDA-regulated organization. During the past 30 years, best practices have been developed that, if followed, can ensure laboratory computer systems are validated efficiently and in compliance with FDA regul........

$237 Recorded (6 months unlimited access)
 Webinar Id: LSHCCT002
 View Anytime
 Duration 90 mins

Organizational Change Management (OCM) Best Practices for Computer Systems Regulated by FDA

This course is intended to provide specific guidelines for coaching attendees on the best practices for creating organizational change as it relates to computer systems regulated by FDA. These include, but are not limited to system implementation, testing, validation, migration, integration, upgrade and retirement.

$237 Recorded (6 months unlimited access)
 Webinar Id: LSHCCT006
 View Anytime
 Duration 90 mins

FDA's Latest Regulations for Tobacco Industry Effective 8/2016

The Tobacco Control Act went into effect by FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016, the FDA finalized a rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, which extends the FDA's authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens)........

$237 Recorded (6 months unlimited access)

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