Data Integrity by Design and Pharma 4.0: Next-Gen Techniques to Approach GxP Systems, and FDA Compliance Across Pharmaceuticals, Medical Devices, Biologics, and Tobacco Products

Dublin, Oct. 27, 2023 (GLOBE NEWSWIRE) -- The "Data Integrity by Design and Pharma 4.0: Next-Gen Techniques to Approach GxP Systems, and FDA Compliance" training has been added to's offering.

This seminar is specifically tailored for professionals working in FDA-regulated industries, including pharmaceuticals, medical devices, biologics, and tobacco products such as e-liquids, e-cigarettes, pouch tobacco, and cigars.

Individuals from various functions within these industries will benefit from this seminar, including those involved in research and development, manufacturing, quality control, distribution, clinical testing, regulatory affairs, adverse event management, and post-marketing surveillance.

The central theme of this seminar is "Data Integrity by Design," which is a critical concept that organizations operating in FDA-regulated industries must adopt. It emphasizes the importance of ensuring data integrity at every stage of the lifecycle of computerized systems, starting from initial planning and continuing through implementation, operation, and eventual retirement. By applying critical thinking, businesses can identify and mitigate risks that have the potential to compromise patient safety and product quality.

In an era where many businesses rely on advanced technologies such as process control, automation, artificial intelligence (AI), and machine learning, effective data management becomes paramount. This is where an integrated laboratory software system plays a crucial role by streamlining processes and upholding data integrity. By doing so, it helps organizations align with a Pharma 4.0 strategy, which is characterized by the integration of modern technologies and data-driven practices into pharmaceutical processes.

This program provides participants with a comprehensive understanding of the industry landscape and how the FDA adapts to evolving technologies. It also delves into the role of Pharma 4.0 in facilitating the development of next-generation medicinal products and creating new business models for established products. To succeed in this initiative, organizations must address various factors, including organizational structure, cultural aspects, and the technical resources required.

Seminar attendees will gain insights into the different stages of maturity associated with Pharma 4.0 and how it can break down silos within organizations while fostering greater connectivity. This seminar aims to equip professionals with the knowledge and tools needed to navigate the complexities of FDA-regulated industries and harness the potential of Pharma 4.0 for enhanced efficiency and compliance.

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

Key Topics Covered:


  • "GxP" Computer Systems and FDA Oversight
  • Computers and Data Integrity
  • FDA Inspection Trends and Data Integrity
  • Computer System Validation (CSV)
  • CSV Maintenance
  • FDA's 21 CFR Part 11 (Electronic Records/Electronic Signatures) Guidance
  • The "12 Theses" of Pharma 4.0
  • Pharma 4.0 vs. Industry 4.0 - Similarities, Differences and Best Practices
  • Q&A


  • 6 ways to improve Productivity and Quality
  • Investment calculations for Pharma 4.0
  • Prerequisites for Pharma 4.0
  • Pharma 4.0 Operating Model
  • Pharma 4.0 Maturity Model
  • Digital Transformation
  • Overcoming DI issues in Cloud
  • Pharma 4.0 - The Future
  • Q&A


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.

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