Navigating GxP standards and the FDA/EMA submission process can be quite challenging. Ensuring safety, quality, and compliance under tight timelines can feel overwhelming at times.
In this video, Paweł Przytuła breaks down GxP validation and software best practices, making the process easier to understand. He provides practical insights to help simplify validation and keep your project on track.
The presentation is available here: [ Ссылка ]
If you're curious about GxP validation, be sure to check out our guide on how the Definition of Done can help streamline your process. Read more: [ Ссылка ]
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0:00 - Introduction
0:11 - Understanding FDA Submissions
0:35 - GxP in the FDA Submission Process
1:17 - Good Programming Practices
2:12 - Importance of Good Development Practices
4:18 - Testing Levels in Software Validation
6:33 - Documentation Practices
7:38 - Risk Management
8:30 - Conclusion
