New FDA Draft Guidance Part 11 Compliance
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations.
Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
This webinar describes
- As part of the Case for Quality program US FDA 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.
- This is where FDA determines “WHAT” is required and the “HOW” to accomplish this can occur in different ways.
- Does not have to be performed according to the “checklist” mindset of most CSV work,
- Where you crank out documents without specifically addressing the risk of potential failure of each requirement.
- GAMP5 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.
Areas Covered
- Discuss FDA Case for Quality
- Discuss CSV -vs- CSA
- Review FDA Draft Guidance Computer Software Assurance (CSA) for Production and Quality System Software
Course Level - Basic / Intermediate
Why Should You Attend
- Learn FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry.
- Discuss ways to modernize the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV) by using automated testing tools that will result in a continuous validation of software products.
- This approach is amenable to the Agile software development methodology, which can be adapted for use in validation.
- We will also discuss the important aspects of CSV and how to apply them in a new and modern technological environment.
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$200.00
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