FREE LIVE WEBINAR – Computer System Validation Trends Regulated by FDA (on July 3 at 4 PM IST)

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Product Id : ISF102
Presenter : Carolyn Troiano (CSV and FDA Expert)
Scheduled On : 03 July, 2019 at 04:00 PM (India Time)
Duration : 60 Minutes
This FREE Webinar is scheduled on
July 3rd, at 4 PM IST
To sign up, please click on the ADD TO BASKET button above and complete the registration process.

You will receive instructions on how to join the session, a day prior to the webinar.

Please use your Official e-mail id to sign up for the course. The login instructions will be sent to your Registered e-mail ID.

For assistance, please call +91-80-4170-0521

Areas Covered

  • Key factors that influence the degree of FDA oversight for CSV programs
  • How to anticipate and understand trends, as they begin to emerge
  • Building a solid relationship with FDA and leverage it to gather information about emerging trends
  • How to adjust your CSV programs to changes in the regulatory environment
  • Applying CSV principles to ensure in emerging trends preparedness
  • CASE STUDY: Factors influencing the regulatory environment and how pharmaceutical companies have reacted or responded
  • CASE STUDY: Risks pharmaceutical companies have taken in response to changes in the regulatory environment and the ramifications

Who Should Attend

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco.  Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.
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:
  • Information Technology Analysts
  • Information Technology Developers and Testers
  • QC/QA Managers and Analysts
  • Analytical Chemists
  • Compliance and Audit Managers
  • Laboratory Managers
  • Automation Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers
  • This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

Presenter Details

Carolyn Troiano Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.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. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.