For over three decades, the FDA has regulated computer system validation in industries like pharmaceuticals, biotechnology, and medical devices. These validations ensure that computer systems involved in production, testing, and distribution operate securely and reliably. Recently, the FDA has taken a major step forward with its Technology Modernization Action Plan (TMAP), aimed at modernizing the way the agency works with the industry. This development marks a shift in focus from merely validating existing systems to also incorporating new technologies such as cloud computing and Software as a Service (SaaS).
With an increasing focus on data integrity, the FDA's modernization plan seeks to set higher compliance standards for all regulated computer systems. This focus isn't just limited to structured data; it extends to unstructured data formats like documents, spreadsheets, and even audio-visual files. Given these evolving guidelines, it is vital for companies in regulated industries to keep pace with the FDA's expectations on computer system validation and data integrity.
In light of these developments, this webinar will focus on deciphering the FDA's Technology Modernization Action Plan and its impact on computer system validations. We will also discuss how to integrate modern technologies into your compliance strategy without compromising data integrity.
Areas covered in the session:
- Learn how to identify “GxP” Systems
- Learn about FDA’s current program for modernization of technology, and how this will impact industry
- Learn about FDA’s Technology Modernization Action Plan (TMAP), including what work is underway and what is planned in the near term
- Discuss the current state of Computer System Validation (CSV) approach based on FDA requirements
- Learn about the System Development Life Cycle (SDLC) approach to validation and how this can be modernized through a more agile approach, including automated testing for continuous validation
- We will discuss cloud computing and Software as a Service (SaaS) systems that can be embraced and validated effectively
- Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures, including ways to improve efficiency and effectiveness
- Understand how to maintain a system in a validated state through the system’s entire life cycle in a more cost-effective manner.
- Learn how to assure the integrity of data that supports GxP work, despite changes and advances in new technology
- Discuss the importance of “GxP” documentation that complies with FDA requirements
- Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
- Know the regulatory influences that lead to FDA’s current thinking at any given time
- Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
Why should you attend?
As FDA continues its technology modernization through the Technology Modernization Action Plan (TMAP), the complexity around Computer System Validation (CSV) is increasing. This webinar provides an invaluable guide to navigate this evolving landscape. Grounded in the System Development Life Cycle (SDLC) Methodology, the session offers a structured framework for planning and implementing your validation strategy, which will withstand FDA scrutiny and assure data integrity throughout a system's entire life cycle.
Maintaining a system in a validated state is as vital as the initial validation. This training program will delineate the policies, procedures, and training elements essential for ongoing system maintenance in a validated state, mitigating any potential risks.
In addition, Data Integrity (DI) has come under the FDA's spotlight, especially during inspections. Over the last decade, DI-related issues have increasingly led to Form 483 citations and Warning Letters. This webinar will equip you with industry best practices and the current regulatory requirements related to DI, setting you up for successful FDA inspections.
What industries will benefit from your training:
Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:
- Pharmaceutical (for drug products introduced using a medical device)
- Medical Device
- Biologicals (for biological products introduced using a medical device)
- Tobacco (based on the Tobacco Control Act of 2009)
- E-Liquid/Vapor (based on the “Deeming” Act of 2016)
- E-Cigarette (based on the “Deeming” Act of 2016)
- Cigar (based on the “Deeming” Act of 2016)
- Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs)
- Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA
Who Should Attend?
- Information Technology Analysts
- 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
- Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
- Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
- Auditors engaged in the internal inspection of labeling records and practices
Carolyn Troiano has more than 40 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.