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 of 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.
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 remains compliant.
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 of 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 remains compliant.
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
- Pharma 4.0™ embeds health regulations best practices into the model
- Pharma 4.0™ breaks silos by building bridges between industry, regulators, healthcare, and other stakeholders
- Pharma 4.0™ is an enabler and business case for Next Generation Medicinal Products
- Pharma 4.0™ offers new business cases for established products
- Innovative approaches for investment calculations in Pharma 4.0™
- Pharma 4.0™ requires an established PQS and controlled processes & products
- Pharma 4.0™ is not an IT project
- The Operating Model includes IT, organizational, cultural, process & resource elements
- The Pharma 4.0™ Maturity Model helps align the organization's operating model to its desired state
- Pharma 4.0™ is not a regulatory must, but a competitive advantage - ignoring it may be a business risk
- Pharma 4.0™ enables innovation in niche products and personalized medicines
- Q&A
Speaker
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.
Who Should Attend
- 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 studying CSV, regulatory affairs, or FDA-related disciplines
