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

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.

• 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

The attendee will learn about Pharma 4.0 and the 4.0 Operating Model. We will discuss how Pharma 4.0 is governed by health regulations and some of the industry best practices that can help improve efficiency and effectiveness.

Pharma 4.0 can expand the connections between companies, FDA, and other stakeholders. During the course, we will review specific business cases for using Pharma 4.0 to determine the return on investment of Pharma 4.0.

We will discuss organizational and cultural practices that are essential to Pharma 4.0 success. We will cover the Pharma 4.0 Maturity Model and how this can provide a competitive advantage to a company.

Clearly, 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.

• 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

Carolyn Troiano has more than 35 years of experience in computer system validation in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.