May 04, Thursday, 2023 (1:00 PM to 4:00 PM) Part 1
May 05, Friday, 2023 (1:00 PM to 4:00 PM) Part 2
May 08, Monday, 2023 (1:00 PM to 4:00 PM) Part 3
May 09, Tuesday, 2023 (1:00 PM to 4:00 PM) Part 4
As part of the Case for Quality program, US FDA Center for Devices and Radiological Health noted how an excessive focus by the industry on compliance rather than quality may be diverting resources and management attention toward meeting regulatory compliance requirements vs. adopting best quality practices. There has also been a lower-than-anticipated investment in automation and digital technologies, which could greatly improve quality and process control.
A key element is a risk-based, product quality, and patient-centric approach to Computer System Assurance (CSA) vs. the traditional Computer System Validation (CSV) waterfall approach. This encourages critical thinking based on product and process knowledge and quality risk management over prescriptive documentation-driven approaches. CSA is the topic of the FDA’s latest draft guidance for the industry.
This is where FDA determined that “WHAT” is required can be done (the “HOW”) in different ways and does not have to be according to the compliance “checklist” mindset of most CSV work, where you create documents without specifically addressing the risk of potential failure of each requirement.
GAMP®5 supports the use of incremental, iterative, and evolutionary approaches including agile, for the development of custom applications. Keys to success include a robust Quality Management System and well-trained and highly disciplined teams following well-defined processes supported by tools and automation.
Advancements in technology have forced organizations to rethink business models, tools, and methodologies. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and have higher expectations than ever before. Work practices and tools must change to meet these challenges.
The approach to developing software, performing validation, and maintaining a system in a validated state through its entire life cycle should be carefully considered in order to meet changing needs. This webinar will include a comparison of the agile and waterfall methodologies, along with the pros and cons of each.
There may not be one size that fits all, so it is important to understand what needs to be considered when making such a determination. We will also cover cloud computing, Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), Platform-as-a-Service (PaaS), Single-Sign-On (SSO), Automated Testing, and the best approach for validating and managing systems, regardless of the technology behind it.
Who Should Attend:-
Any Organization, Institution or Group User can register
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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.
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