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.
As the 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 navigating 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.
As the 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 navigating 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.
Carolyn Troiano
Carolyn Troiano has more than 35 years of experience in computer system validation 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. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a …
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