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
This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, 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.
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.
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.
Course Content
- 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 organization’s 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.
- Computer System Validation (CSV)
- Computer Software Assurance (CSA)
- Waterfall Methodology
- Agile Methodology
- System Development Life Cycle (SDLC) Methodology
- GAMP®5 2nd Edition
- GAMP®5 “V” Model
- Automated Testing
- Critical Thinking
- Cloud Computing
- Software as a Service (SaaS)
- Q&A
Course Provider
Carolyn (McKillop) Troiano,
IT Program Manager and FDA Compliance Consultant ,
Smart Resources, Inc.Carolyn (McKillop) Troiano has more than 35 years of experience 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, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.
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.
Who Should Attend
Personnel in the following roles will benefit:
- Information Technology Analysts
- Information Technology Managers
- QC/QA Managers
- QC/QA Analysts
- Clinical Data Managers
- Clinical Data Scientists
- Analytical Chemists
- Compliance Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Managers
- Manufacturing Supervisors
- Supply Chain Specialists
- Computer System Validation Specialists
- GMP Training Specialists
