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Current Trends in FDA Oversight of Regulated Computer Systems Webinar  

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Information technology analysts, project managers, organizational change managers, business process engineers, QC/QA managers and analysts, clinical data managers and scientists, analytical chemists, compliance managers, lab managers to name a few.

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Seminar Summary:

This course is intended to provide specific guidelines for coaching attendees on the current trends and related challenges that will be faced by industry over the course of the next several years, as well as the best practices for preparing for and dealing with them effectively. (see full course description)

 

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Training Course Syllabus:


Current Trends in FDA Oversight of Regulated Computer Systems Webinar

Time: 10:00 AM PST | 01:00 PM EST

Duration: 60 Minutes

Instructor:
Carolyn Troiano

Description:

This course is intended to provide specific guidelines for coaching attendees on the current trends and related challenges that will be faced by industry over the course of the next several years, as well as the best practices for preparing for and dealing with them effectively.

Why Should you Attend:

The attendee will learn how to develop a standard approach to predicting and identifying trends through research, networking and understanding the "big picture" of the FDA-regulated marketplace. These will be captured in the risk profile to keep track of events as they happen and develop plans for meeting them head on.

While this is an advanced course, and most people will be fairly well familiar with the concepts of computer system validation in an FDA-regulated environment, we will touch on those areas that are critical to watch, including security and newer technologies that are emerging for capturing, analyzing, storing and reporting information for decision-making purposes. It´s important to look at what are some of the threats and challenges, and what methods you can use to mitigate these. Similarly, it is important to identify opportunities that might help companies decrease the cost of compliance and improve operational efficiencies and effectiveness.

There is an enormous body of documentation and information available that 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 techniques and tools available to assure compliance when managing activities related to handling data.


Objectives of the Presentation:

The course will focus on the key trends in the FDA-regulated marketplace, which may be the result of economic, social, technological, political or other factors. We will present best practices and principles for establishing and maintaining computer system compliance in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution of the product, or during any other functional activity). The material will include the various aspects of system and data related projects, and the result will be a prescriptive approach to helping teams and individuals reach a higher level of compliance.

FDA guidelines are very specific in terms of how computer systems are to be managed, and each company should have a specific strategy and methodology, along with a set of rigorous tactical processes and procedures that prescribe how everyday work, along with the challenges and risks should be managed.

Who Should Attend

Information technology analysts, project managers, organizational change managers, business process engineers, QC/QA managers and analysts, clinical data managers and scientists, analytical chemists, compliance managers, lab managers, automation analysts, computer system validation specialists, GxP training specialists, business stakeholders and individuals who are responsible for computer system validation planning, execution, testing, reporting, compliance, and audit. This webinar will also benefit any consultants, contractors or vendors providing products and services to the life sciences industries and who are involved in computer system implementation, validation and compliance.

Seminar Summary:

This course is intended to provide specific guidelines for coaching attendees on the current trends and related challenges that will be faced by industry over the course of the next several years, as well as the best practices for preparing for and dealing with them effectively. (see full course description)

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