FDA's Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data

Carolyn Troiano
Instructor:
Carolyn Troiano
Date:
Thursday, February 18, 2021
Time:
10:00 AM PST | 01:00 PM EST
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 503506

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
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Overview:

This webinar will focus on the efforts by FDA to modernize their own technology infrastructure, and what this means to industry.

We will cover the Technology Modernization Action Plan (TMAP) that has been launched by FDA for this purpose and discuss specific actions that are planned and in progress.

We will also discuss FDA's more recent push to Software Quality Assurance (SQA) and away from traditional Computer System Validation (CSV), which is based on the System Development Life Cycle (SDLC) methodology.

FDA is stressing the importance of industry understanding what is required to be in compliance and thinking critically about new ways to achieve that. We will cover automated testing and continuous validation as key components of the SQA approach.

Why you should Attend: The attendee will learn about FDA's approach to modernizing technology, and how that will benefit both the Agency and industry.

We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV) by using automated testing tools that will result in a continuous validation of software products.

We will also discuss the important aspects of CSV and how to apply them in a new and modern technological environment.

Areas Covered in the Session:

  • Learn how to identify "GxP"Systems
  • Learn about FDA's current program for modernization of technology, and how this will impact industry
  • Learn about FDA's Technology Modernization Action Plan (TMAP), including what work is underway and what is planned in the near term
  • Discuss the current state of Computer System Validation (CSV) approach based on FDA requirements
  • Learn about the System Development Life Cycle (SDLC) approach to validation and how this can be modernized through a more agile approach, including automated testing for continuous validation
  • We will discuss cloud computing and Software as a Service (SaaS) systems that can be embraced and validated effectively
  • Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures, including ways to improve efficiency and effectiveness
  • Understand how to maintain a system in a validated state through the system's entire life cycle in a more cost-effective manner
  • Learn how to assure the integrity of data that supports GxP work, despite changes and advances in new technology
  • Discuss the importance of "GxP"documentation that complies with FDA requirements
  • Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
  • Know the regulatory influences that lead to FDA's current thinking at any given time
  • Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
  • Q&A

Who Will Benefit:
  • Information Technology (IT) Analysts
  • IT Developers
  • IT Support Staff
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Compliance Managers and Auditors
  • Lab Managers and Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders using Computer Systems regulated by FDA
  • Regulatory Affairs Personnel
  • Consultants in the Life Sciences and Tobacco Industries
  • Interns working at the companies listed above
  • College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements


Speaker Profile
Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device 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. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

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.


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