Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
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 should you 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
Areas Covered in the Session:
Subscribe for Compliance Alerts Research Reports Absolutely Free