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FREE ON-DEMAND WEBINAR
How to Avoid Common Problems with your Design, Risk, and Validation Documentation
Consider these scenarios...
- You don’t have access to the previously recorded information from your design history file...
- One of your colleagues mistakenly submits an outdated version of a document to an FDA inspector...
- You're unable to show the traceability of your design and development activities...
...because they happen more often than not. And at that point, it's only a matter of time before the nonconformances, complaints, 483’s, warning letters and more start rolling in the door.
This presentation will provide simple ways you and your team can learn to integrate documentation best practices so you can mitigate risk, systemic issues, and those unwanted scenarios above.
Watch the webinar
Specifically, this webinar will cover:
- How design and development activities are connected to your quality management documentation
- Why you shouldn’t view your design controls as disconnected items
- Why it’s important to document your design and development activities properly the first time
- Why the belief that design and development documentation slows or hinders development is a myth
- How the most progressive device companies are utilizing tools that enable clean trace matrices
- The future state of these tools and how they’re trending toward becoming the industry standards
- Q&A Session
Who Should Attend?
- Medical Device Executives
- Regulatory Affairs Professionals and Management
- Quality Professionals and Management
- Clinical Affairs Professionals and Management
- R&D Engineers and Management
