For almost 40 years, the FDA has controlled computer system validation in relation to systems used in the production, testing, and distribution of a product in the biotechnology, pharmaceutical, medical device, and other FDA-regulated industries. Computer systems used for data collection, analysis, and reporting must be carefully planned, implemented, integrated, tested, and managed in accordance with FDA regulations.
Guidelines for electronic records and electronic signatures (ER/ES) were created by the FDA in 1997 and published under 21 CFR Part 11. The fundamental specifications for verifying and recording ER/ES capabilities in systems utilized in an FDA-regulated setting are outlined in this code.
The FDA acknowledged in the early 2000s that they could not examine every computer system at every regulated business and left the responsibility for evaluating all regulated computer systems according to risk on the industry. Each company's approach to creating a validation strategy and justification as part of the planning process required to be based on the degree of potential risk, should the system malfunction. The five main factors that determine the extent and quality of testing needed to guarantee data integrity and product safety are system size, complexity, business criticality, GAMP 5 category, and risk rating.
The FDA's current emphasis on data integrity during audits and validation inspections of computer systems has raised awareness of the significance of this issue for system compliance in regulated businesses. All systems that "touch" products—that is, those that are used to generate, gather, process, handle, transmit, and report FDA-regulated data—fall under this category. Throughout their whole life cycle, all data—structured, such as databases, and unstructured, such as documents, spreadsheets, presentations, photos, audio, and video files, among others—must be managed and preserved with integrity.
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 :
Attendees will get knowledge of the 4.0 Operating Model and Pharma 4.0. We will go over some of the industry best practices that can assist increase efficacy and efficiency as well as how Pharma 4.0 is regulated by health laws.
Pharma 4.0 can strengthen ties between businesses, the FDA, and other interested parties. In order to calculate the return on investment of Pharma 4.0, we will examine particular business cases throughout the course.
We'll talk about organizational and cultural behaviors that are critical to the success of Pharma 4.0. We'll talk about the Pharma 4.0 Maturity Model and how it can give a business a competitive edge.
Pharma 4.0TM is undoubtedly a competitive advantage rather than a necessity. There could be a business risk if Pharma 4.0TM is missed. Pharma 4.0TM provides fresh perspectives on business cases as the industry transitions from blockbusters to specialty goods and customized medications.
Areas covered in the session:
Learning Goals:
• Acquire knowledge about Pharma 4.0's "12 Theses."
• The Industry 4.0 Operating Model for pharmaceuticals is expanded upon and explained by Pharma 4.0TM.
• Pharma 4.0TM incorporates best practices for health regulations in accordance with popular Industry 4.0 concepts.
• By creating connections between industry, regulators, healthcare, and all other stakeholders, Pharma 4.0TM dismantles organizational silos.
• Pharma 4.0TM is THE commercial case and enabler for the next generation of pharmaceutical products.
• New business cases for the established goods are provided by Pharma 4.0TM.
Pharma 4.0TM investment estimates necessitate creative methods for business case computations.
• Pharma 4.0TM requires controlled processes and products as well as an established PQS.
• Pharma 4.0TM isn't an IT initiative.
• In addition to IT, the Pharma 4.0TM Operating Model takes organizational, cultural, process, and resource factors into account.
• The Pharma 4.0TM Maturity Model enables enterprises to match their operating model with a suitable desired state for suppliers, contractors, and both established and new industries.
• Pharma 4.0TM is a competitive advantage but not a necessity. There could be a business risk if Pharma 4.0TM is missed.
• Pharma 4.0TM provides fresh perspectives on business cases as we transition from blockbusters to specialty goods and customized medications.
• Q&A
Who should attend this:
Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GDPs:
Personnel in the following roles will benefit:
Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco, e-cigarette/e-liquid and other FDA-regulated industries.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe, developing validation programs and strategies, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
