Overview

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.

So what is next for the modernization of the processes involved in compliance for FDA-regulated systems, keeping in mind the guidance documents provide thus far? The FDA is embarking on a modernization program to update their 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 industry to move forward as technology continues to improve. The FDA plans to take advantage of these technologies, just as 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 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 best practices in the model.

We 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, 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.

Why You Should Attend

The attendee will learn about ways to approach the computer system validation of any FDA-regulated system. There are traditional methods that have been followed for decades now, but these document-driven efforts are laborious and time consuming. Some practices over time have also led to many myths about what FDA requires. We’ll dig into the guidance documents from FDA and how to better understand exactly what they are expecting from industry stakeholders.

Certain approaches and methodologies for validation, along with newer technologies may be leveraged to more efficiently complete the work without sacrificing quality or compliance. We’ll cover all types of systems, including on-premise servers and applications, cloud-based systems, and Software-as-a-Service (SaaS) solutions. There are best practices that will lead to reducing time and cost, and delivering a system in a validated state. Leveraging vendor documentation, to the degree possible, can remove redundancy. While a vendor’s documentation is never to be a sole source of proof the system meets the requirements, it may still be evaluated to determine whether it’s in line with your company’s practices, policies, procedures, and any standards required, and could be adapted for use.

We’ll also cover how to maintain the system in a validated state and what that means. There are specific practices and activities that must be done to ensure the system

Webinar Takeaway

  • 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 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
  • Investment calculations for Pharma 4.0™ require innovative approaches for business case calculations.
  • Prerequisite for Pharma 4.0™ is an established PQS and controlled processes & products
  • Pharma 4.0™ is not an IT Project
  • The Pharma 4.0™ Operating Model incorporates next to IT also the organizational, cultural, processes & resources aspects
  • The Pharma 4.0™ Maturity Model allows aligning the organizations operating model for innovative and established industries, suppliers and contractors to an appropriate desired state
  • 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
  • Q&A

Who Will Benefit

  • 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 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


Faculty Carolyn Troiano

Award winning FDA Compliance Expert for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity.

My experience includes 40+ years in IT/ Business, Marketing & Compliance leadership and management roles at a variety of Fortune 100 companies, across multiple industries.

My successes include building and managing teams and business units at multiple “greenfield” sites in the pharmaceutical, biotechnology and IT consulting industries, as well as in the public sector. I have weathered numerous layoffs, mergers and acquisitions, and demonstrated my very strong leadership skills in helping staff get through difficult times.

Ms. Troiano has specific expertise in Computer System Validation (CSV), 21 CFR Part 11, FDA’s Guidance on Electronic Records and Electronic Signatures (ER/ES), and Data Integrity. She received her MBA from Rutgers University and a BS in Toxicology from St. John’s University.

1.5 RAC CREDITS

RAPS - This course has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.

World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria

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