Project Management for Computer Systems Regulated by FDA

Duration: 60 Minutes
Project management principles can be used to ensure that all efforts to develop, configure, implement, test, validate and maintain a computer system is compliant.specific in terms of how this is to be done.
Computer Systems Validation
Instructor: Carolyn Troiano
Product ID: 500468

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.specific in terms of how this is to be done.

We will discuss the importance of applying industry best practices when managing projects involving development, configuration, implementation, testing, validation and other System Development Life Cycle (SDLC) phases for any IT system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. specific in terms of how this is to be done.

This course will describe the best practices for managing such a project, including "who" should be responsible for tasks, "how" the documentation should be accomplished, and "what" specific criteria will be used to define success. FDA guidelines are very specific in terms of how this is to be done.

Why Should you Attend:
You should attend this seminar if you are responsible for planning or executing the implementation, validation, and/or ongoing management of a computer system governed by FDA regulations. It is critical that the project is managed in line with the system development life cycle (SDLC) requirements that FDA has set forth for all computer systems used in the manufacturing, testing, distribution and tracking of a regulated product, such as a drug or biologic.

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that the cost of building and managing a computer system validation program will be minimized, and exercising good project management principles is at the core of achieving the appropriate compliance to cost ratio.

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 of methods, techniques and tools available for managing projects related to systems regulated by FDA.

Objectives of the Presentation:
  • Upon completion of this session, attendees will have an understanding of computer system project planning, execution and management concepts and how these efforts are to be adequately documented to meet FDA requirements.
  • Participants will understand the steps required for documenting the phases of the project, along with the key documentation associated with maintaining the systems in a compliant state, while minimizing costs.
  • The attendees will have a good grasp of how to leverage these practices across all systems by creating a standardized program.
Who can Benefit:
  • Information technology analysts
  • QC/QA managers and analysts
  • Clinical data managers and scientists
  • Analytical chemists
  • Compliance managers, lab managers
  • Automation analysts
  • Computer system validation specialists
  • GMP training specialists
  • Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, and audit.
  • Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Carolyn Troiano has more than 35 years of experience in the pharmaceutical, medical device, tobacco 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.
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