Explore how Pharma 4.0's operating model modernizes FDA-regulated computer system validation — reducing cost and complexity while building sustainable, inspection-ready data integrity by design.
Includes live access & recording
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" product, 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.
The FDA is embarking on a modernization program to update their technology and processes for working with industry. There are numerous programs underway, including partnerships with other agencies and industry to move forward as technology continues to improve. Cloud computing, automated computer system testing and mobile devices are just part of the mix expected to explode in the near term.
Pharma 4.0 provides an operating model for FDA-regulated products that embeds health regulations best practices into the model — enabling organizations to move faster, reduce redundancy, and maintain a validated state cost-effectively.
Traditional computer system validation has been followed for decades — but these document-driven efforts are laborious and time consuming. Some practices over time have also led to many myths about what FDA truly requires.
Certain approaches and methodologies for validation, along with newer technologies, may be leveraged to more efficiently complete the work without sacrificing quality or compliance. Leveraging vendor documentation, to the degree possible, can remove redundancy — while still meeting your company's policies, procedures, and required standards.
This webinar gives you the strategies to reduce time and cost, deliver systems in a validated state, and maintain ongoing compliance — across on-premise, cloud-based, and SaaS solutions — using the Pharma 4.0 operating model as your framework.
Four strategic focus areas that will equip you to implement Pharma 4.0 principles and build cost-effective, inspection-ready data integrity programs.
Understand the "12 Theses" of Pharma 4.0 and how the operating model extends Industry 4.0 for medicinal products — embedding regulatory best practices and breaking silos between industry, regulators, and healthcare stakeholders.
Learn how to build data integrity into systems from the ground up — not as an afterthought — covering structured and unstructured data across the full lifecycle in cloud, SaaS, and on-premise environments.
Explore how automated testing, cloud computing, and mobile devices are reshaping CSV — and how to leverage these technologies while satisfying FDA expectations for validated states and ongoing compliance.
Discover practical risk-based strategies and vendor documentation approaches that reduce redundant effort, accelerate validation timelines, and lower the total cost of compliance without compromising quality.
Fourteen focused topics covering the Pharma 4.0 framework, data integrity by design, and modern approaches to cost-effective 21 CFR Part 11 compliance.
IT, quality, compliance, and validation professionals in pharmaceutical, medical device, and other FDA-regulated industries responsible for computer system validation and data integrity.
Information Technology (IT) Analysts
IT Developers
IT Support Staff
IT Security Staff
QC/QA Managers and Analysts
Production Managers and Supervisors
Supply Chain Managers and Supervisors
Clinical Data Managers and Scientists
Compliance Managers and Auditors
Lab Managers and Analysts
Computer System Validation Specialists
GMP, GLP, GCP Training Specialists
Business Stakeholders Using FDA-Regulated Computer Systems
Regulatory Affairs Personnel
Consultants in Life Sciences and Tobacco Industries
Interns & College Students in CSV or FDA-Related Disciplines
FDA's sustained focus on data integrity during computer system validation inspections has made 21 CFR Part 11 compliance a top priority across pharmaceutical, medical device, and other regulated industries. All systems that "touch" product — from databases and spreadsheets to audio files and electronic records — must maintain data integrity throughout their entire lifecycle.
The FDA is simultaneously embarking on a broad modernization program, leveraging partnerships with other agencies and industry to move forward as technology rapidly evolves. Cloud computing, automated validation tools, and mobile devices are reshaping how organizations approach regulated systems — and the FDA plans to take advantage of these same technologies, provided they are employed in ways that promote public health and compliance.
Pharma 4.0 offers a structured operating model that responds directly to this moment — embedding regulatory best practices into the way organizations design, validate, and maintain FDA-regulated systems. Unlike earlier, document-heavy approaches to 21 CFR Part 11, Pharma 4.0 enables organizations to work smarter: reducing redundancy, accelerating time-to-market, and delivering validated systems at significantly lower cost — without sacrificing the quality and compliance rigor FDA demands.
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 and is currently active in the PMI, AITP, and RichTech. She volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.
Join Carolyn Troiano for this 90-minute deep-dive into Pharma 4.0, data integrity by design, and cost-effective strategies for 21 CFR Part 11 compliance in the modern regulated environment.