In this informative webinar, industry experts delve into the critical aspects of software validation in cell and gene therapy (CGT) labs. Greg Rathmell, Vice President of Product and Marketing at Title 21, leads a discussion with panelists Krisha Patel (Co-founder of Assurea), Anthony Island (Quality Management Professional), and Abegail Carpenter (Manager of Professional Services at Title 21). They share real-world experiences and best practices to streamline validation processes and ensure compliance.
Key Takeaways:
- Proactive Communication: Open communication between vendors and healthcare organizations is essential for successful software validation. Clarify expectations, regulatory requirements, and terminology upfront to avoid misunderstandings and delays.
- Risk-Based Validation: Utilize a risk-based approach to focus validation efforts on critical features that impact product quality and patient safety. This approach allows for efficient testing and minimizes unnecessary documentation.
- Clear Documentation: Maintain comprehensive documentation throughout the validation process, ensuring traceability and clarity. This is crucial for demonstrating compliance and facilitating smooth upgrades and future audits.
Watch the full webinar recording to gain deeper insights into navigating the complexities of CGT validations. If you have a question about this topic, send a message to info@title21.com.
