Pharma 4.0 and the Future of Validation of Computer Systems Regulated by FDA

Carolyn Troiano
From: Sep 09, 2022 - To: Dec 31, 2022
Recorded Webinar


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.

Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997 and disseminated through 21 CFR Part 11.  This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.

In the early 2000s, FDA recognized they could not inspect every computer system at every regulated company and placed the onus on industry to begin assessing all regulated computer systems based on risk.  The level of potential risk, should the system fail to operate properly, needed to be the basis for each company’s approach to developing a validation approach and rationale as part of the planning process.  System size, complexity, business criticality, GAMP 5 category, and risk rating are the five key components for determining the scope and robustness of testing required to ensure data integrity and product safety.

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries.  These include all systems that “touch” products, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA.  All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio, and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.

So, what is next for the modernization of the processes involved in compliance with FDA-regulated systems, keeping in mind the guidance documents provide thus far?  The FDA is embarking on a modernization program to update its technology and processes for working with industry to assure regulated products meet FDA compliance.  There are numerous programs underway, including partnerships with other agencies and industries to move forward as technology continues to improve.  The FDA plans to take advantage of these technologies, just as the industry is focused on the same goal.  The key is making sure these are employed in a way that promotes public health, providing more improved FDA-regulated products with fewer negative side effects and issues.  Plans will also enable FDA to work with the industry to move products to market faster, further improving public health.

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

We will explore the best practices and strategic approaches for evaluating the current processes involved in assuring computer systems used in the conduct of 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, we 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.

Areas Covered:-

  • Learn about the “12 Theses” of Pharma 4.0
  • Pharma 4.0™ extends/describes the Industry 4.0 Operating Model for medicinal products
  • In deference to common Industry 4.0 approaches, Pharma 4.0™ embeds health regulations and best practices
  • Pharma 4.0™ breaks silos in organizations by building bridges between industry, regulators and healthcare, and all other stakeholders
  • For the next Generation Medicinal Products, Pharma 4.0™ is THE enabler and business case
  • For the established products, Pharma 4.0™ offers new business cases

Learning Objectives:-

  • Learn about the “12 Theses” of Pharma 4.0
  • Learn about health regulation best practices
  • Understand the impact of moving to Pharma 4.0 on an organization, including cultural, process, and resource aspects
  • Understand how Pharma 4.0 is not an IT project
  • Learn how to use Pharma 4.0 as a competitive advantage
  • Learn about business cases and how to look at these differently

Why Should You Attend:-

This webinar is intended for those involved in planning, executing, and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical devices, biologics, tobacco, and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.).  Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, regulatory affairs and submissions, adverse events management, and post-marketing surveillance.

The program will provide you with a current snapshot of the state of industry and FDA as both forge ahead in the face of ever-changing technology. The course provides insight into the ways in which Pharma 4.0™ will serve as an enabler for next-generation medicinal products and new business cases for established products. The organizational, cultural, and technical processes and resources are key to the success of this endeavor.

You’ll learn about the various stages of maturity for Pharma 4.0, moving toward a breakdown of silos in organizations and greater connectivity across the enterprise.

Who Should Attend:-

  • Information Technology Analysts
  • Information Technology Developers and Testers
  • Software Quality Assurance Professionals
  • QC/QA Managers and Analysts
  • Analytical Chemists
  • Compliance and Audit Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Specialists and Managers
  • Supply Chain Specialists and Managers
  • Regulatory Affairs Specialists
  • Regulatory Submissions Specialists
  • Risk Management Professionals
  • Clinical Data Analysts
  • Clinical Data Managers
  • Clinical Trial Sponsors
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers
  • Vendors responsible for software development, testing, and maintenance
  • Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation, and compliance

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