FDA Compliance and Laboratory Computer System Validation


Carolyn Troiano is Keynote Speaker at ComplianceKey.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 conf........

Overview

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 regulations.
There is an enormous body of documentation and information available on computer system validation, which can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available.

Why should you attend this webinar?

You should attend this webinar if you are responsible for planning, executing or validating a laboratory computer system, or managing the system in a validated state through the end of the system life cycle. The webinar will take you through the validation process, indicating key aspects of the approach, including GAMP 5 System Classification, Risk Assessment and overall development of a sound validation strategy.
The webinar will cover the actual validation phases, deliverables and key points to ensuring the work is in accordance with FDA requirements for computer system validation, while also making sure the approach is cost effective for your organization.
All aspects of the work will be covered, including roles and responsibilities, timing of phases and deliverables, business process reengineering, organizational change management, change control and audit trails, training and documentation. You will learn what is required not only to validate your laboratory system, but maintain it in a validated state until it is retired or otherwise no longer in use.

Areas Covered in the Session:

Who can Benefit:

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:

This webinar will also benefit any consultants working in the life sciences and tobacco-related industries who are involved in computer system implementation, integration, validation and compliance.



Webinar Id: LSHCCT003

Training Options:

Duration: 90 mins

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 Recorded: [Six month unlimited access]

 $167 (Single Attendee)  $599 (Unlimited Attendee)

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