Are you dreading having to explain and execute software validation? Is your process for validation the same, always? The need to test automated systems in manufacturing and quality system software is 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 be onsite to help you know how to:
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Determine what software requires validation
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How to assess the software’s functional risks
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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 tips and tricks that, with practice, will help you implement a risk-based validation program and maintain that approach during the change process.
Who Should Attend: Anyone who is involved in Quality, Software Assessment & Validation and Equipment Qualifications.
When: Wednesday, September 18th 6:00 pm - 8:00 PM CST
Check In starts at 5:45 pm, a light meal will be provided
Where: Onsite at: St. Cloud State - Plymouth 9750 Rockford Road, Suite #100, Plymouth MN
ZOOM Link: If you live out of state but would like to attend, please use the Comment field during
your registration to request a Zoom link. The link will be provided closer to the event date.
Cost:
Certificates of Completion: Issued via email, after event completion, for .2 ASQ RUs or .2 CEUs
If you have any special requests or questions, please contact Sahi Datla at sahithidatla@gmail.com
Speaker:
Karen Peifer, Silk Road Medical, Principal Quality System Software Engineer, is a leader in non-product software validation with over 24 years of experience, 14 years in a regulated environment. Her career includes validation of online trading systems, automated systems in manufacturing, spreadsheet validation, ERP, systems in contract manufacturing, and the pharmaceuticals realm. Karen is currently at Silk Road Medical, where she is implementing a risk-based validation program for Quality System software and automated systems in manufacturing.