Are you dreading having to explain and execute software validation? Is your process for validation the same process, always? The need to test automated systems in manufacturing and quality system software is required, and often misunderstood. Risk assessments typically involve an FMEA approach, and testing is done via test scripts.
For years, the FDA has been trying to tell us there is another way to make it easier. Easier doesn't mean cut-rate. Do you struggle with where to start? This is the conversation for you.
Karen will discuss with you how to:
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Determine what software requires validation
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How to assess the risk of a software’s functions
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How to right-size testing efforts
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How to develop a risk-based change processes
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How to document and deliver proof of meeting the requirements for validation that tells the right story.
This session is intended to help you think of different ways to conquer the validation process, whether you are still using paper or an electronic QMS. Karen will present practical tips and strategies to help you implement an efficient and compliant risk-based validation program that ensures quality and can be maintained during the change process.
Who Should Attend: Anyone who is involved in Quality, Software Assessment & Validation, and Equipment Qualifications.
When: Wednesday, October 15th 5:30 pm - 8:00 PM CST
Where: Online: The registration information for the Zoom link will be provided closer to the event date.
Cost:
THIS EVENT REQUIRES REGISTRATION. YOU WILL FIND THE LINK AT THE BOTTOM OF THIS POST BY SELECTING MORE INFORMATION.
Certificates of Completion: Issued via email, after event completion, for .3 ASQ RUs or .3 CEUs
If you have any special requests or questions, please contact Sahi Datla at asqmnbmc@gmail.com
Your Speaker:
Karen Peifer, is a leader in non-product software validation with over 25 years of experience testing software, with 13 years in a regulated environment. Her career includes validation of online trading systems, automated systems in manufacturing, NCMR software, spreadsheet validation, ERP systems, to name a few.
Karen has introduced an innovative risk-based validation program for locations in Minnesota's thriving "Medical Alley." This program enhances the quality of validation deliverables, reduces the stress associated with a one-size-fits-all approach, and empowers subject matter experts to think critically and assess how to meet their specific validation needs. Software is like a story, though it may seem familiar each time, its nuances can transform it with every iteration.
Sponsor Information
The MN ASQ Biomedical Consortium (BMC) is a group of quality professionals promoting and advancing quality tools, principles, and practices through educational events. We focus on the medical device industry but promote events for other regulated environments.
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To become a member of the MN ASQ Biomedical Consortium, please contact Sahi Datla, Co-Chair or Karen Peifer, the committee's Chair, at asqmnbmc@gmail.com.
The American Society for Quality (ASQ), is a knowledge-based global community of quality professionals, with nearly 80,000 members dedicated to promoting and advancing quality tools, principles, and practices in their workplaces and communities. As your career partner, ASQ membership benefits are designed to help meet your growing needs as a quality professional. Membership provides exclusive access to quality knowledge, solutions, and resources to solve challenges, and skill development to advance your career. ASQ is committed to providing enhanced expertise, professional networks, tools, and solutions to help our members advance their products, services, and industries.
ASQ: https://www.asq.org/