Pharma 4.0: Next Generation Technology Approach to GxP Products, Systems, Data, & FDA Compliance

Carolyn Troiano

Carolyn Troiano

Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, computer system validation and large-scale IT system implementation projects.
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July 09, 2024
01:00 PM ET | 12:00 PM CT
90 Mins

For almost four decades, the FDA has governed computer system validation with regard to systems utilized in the production, testing, and distribution of goods in the biotechnology, pharmaceutical, medical device, and other FDA-regulated sectors. The requirements set forth by the FDA guarantee careful planning, execution, integration, testing, and administration of computer systems utilized for data collection, analysis, and/or reporting.

FDA regulations from 1997 brought electronic records and electronic signatures (ER/ES) into existence, and 21 CFR Part 11 distributed them.  The fundamental specifications for verifying and recording ER/ES functionality in systems operating in an FDA-regulated setting are outlined in this code.

The FDA acknowledged in the early 2000s that it was not possible to audit every computer system at every regulated company. As a result, the industry was given the responsibility of evaluating every regulated computer system according to risk. The degree of possible risk, in the event that the system malfunctioned was to serve as the foundation for every company's strategy while creating a validation plan and justification throughout the planning phase. The extent and robustness of testing necessary to guarantee data integrity and product safety are determined by five important factors: system size, complexity, business criticality, GAMP 5 category, and risk rating.

Data integrity is now a major concern for the compliance of systems used in regulated industries due to the FDA's new attention on it during computer system validation inspections and audits. These comprise all systems that "touch" products, i.e., those that are used to generate, gather, examine, organize, transfer, and report data that is subject to FDA regulations. Data must be handled and preserved with integrity throughout their whole life cycle, including databases and unstructured data such as documents, spreadsheets, presentations, photos, audio, and video files, among others.

Considering the guidance documents provided thus far, what steps will the modernization of the procedures involved in compliance for FDA-regulated systems take next?  As part of a modernization effort, the FDA is updating its technology and procedures for collaborating with businesses to ensure that regulated products comply with FDA regulations.  Many initiatives, including collaborations with other organizations and businesses, are in progress to keep up with the rapid advancement of technology.  The industry is focused on the same objective, and the FDA intends to capitalize on these advances.  Making sure these are used in a way that advances public health and produces better FDA-regulated products with fewer unfavorable side effects and problems is crucial.  Plans will also allow the FDA to collaborate with businesses.

Pharma 4.0 provides an operating model for FDA-regulated products. It embeds health regulations and best practices in the model.

This session by industry expert Carolyn Troiano, will explore the best practices and strategic approach for evaluating the current processes involved in assuring computer systems used in the conduct FDA-regulated activities are modernized and streamlined. Cloud computing, automated computer system testing, and mobile devices are just part of the mix we can expect to explode in the near term.

Finally, Carolyn will provide an overview of industry best practices, with a focus on data integrity and risk assessment that can be leveraged to assist in all your GxP work.

Webinar Objectives

This webinar aims to provide insights into the modernization of procedures involved in compliance for FDA-regulated systems. It will explore the evolution of FDA regulations related to computer system validation (CSV), particularly focusing on electronic records and electronic signatures (ER/ES) under 21 CFR Part 11. The session will discuss the industry's responsibility in evaluating and validating regulated computer systems based on risk, as well as the importance of data integrity throughout the data lifecycle.

Industry expert Carolyn Troiano will guide attendees through best practices and strategic approaches for evaluating and modernizing processes related to FDA-regulated activities. The webinar will delve into emerging trends such as cloud computing, automated system testing, and the use of mobile devices. Additionally, the session will provide an overview of the "12 Theses" of Pharma 4.0, highlighting its role as an enabler for next-generation medicinal products and offering new business cases for established products.

By the end of the webinar, attendees will gain a comprehensive understanding of industry best practices, with a focus on data integrity and risk assessment, that can be applied to their GxP work in FDA-regulated industries.

Webinar Agenda

  • Introduction to Pharma 4.0 and its role in FDA-regulated industries
  • The integration of health regulations and best practices in the Pharma 4.0 operating model
  • Breaking silos in organizations through Pharma 4.0
  • The impact of Pharma 4.0 on next-generation and established medicinal products
  • Innovative approaches for calculating business cases for Pharma 4.0 investments
  • Establishing a prerequisite for Pharma 4.0 through a robust Pharmaceutical Quality System (PQS) and controlled processes & products
  • Understanding Pharma 4.0 as an organizational transformation, not just an IT project
  • The Pharma 4.0 Maturity Model and Aligning Organizational Operating Models
  • Leveraging Pharma 4.0 as a competitive advantage and mitigating business risks
  • Exploring new business cases with Pharma 4.0 for niche products and personalized medicines
  • Question & Answer Session

Webinar Highlights

  • Learn about Pharma 4.0 and the 4.0 Operating Model
  • Understand how Pharma 4.0 is governed by health regulations and best practices
  • Learn how Pharma 4.0 can expand the connections between companies, FDA, and other stakeholders.
  • Learn about specific business cases for using Pharma 4.0
  • Understand the return on investment of Pharma 4.0
  • Understand the organizational and cultural practices that are essential to Pharma 4.0
  • Learn about the Pharma 4.0 Maturity Model and how this can provide a competitive advantage
  • Pharma 4.0™ is not a must, but a competitive advantage. Missing Pharma 4.0™ might be a business risk.
  • When moving from blockbusters to niche products and personalized medicines, Pharma 4.0™ offers new ways to look at business cases.

Who Should Attend

This webinar is intended for professionals involved in planning, executing, and supporting computer system validation activities in FDA-regulated industries, including pharmaceuticals, medical devices, biologics, tobacco, and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Relevant functions may include research and development, manufacturing, quality control, distribution, clinical testing and management, sample labeling, adverse events management, and post-marketing surveillance.

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