Webinar On Demand: Device and Container Testing for Pharmaceutical Products - A CRO Perspective
Through real-world insights from a contract research organization (CRO) perspective, the webinar also examines risk management, common pitfalls in regulatory submissions, and the importance of validated test methods. Attendees gain a deeper understanding of how to design robust testing programs for a wide range of delivery systems, including prefilled syringes, autoinjectors, and on-body devices, while ensuring performance, safety, and compliance across the product lifecycle.
Webinar Highlights
- Drug delivery systems testing: Role of design verification testing (DVT) in supporting regulatory submissions for combination products
- Design verification vs validation: Understanding requirements to meet FDA and global regulatory expectations
- ISO 13485 compliance: Building quality management systems aligned with FDA 21 CFR Part 820 and global markets
- Medical device risk management: Applying ISO 14971 to define design inputs and reduce patient and user risk
- Harmonized standards: Leveraging ISO and ASTM standards to streamline device and container testing
- Test method validation: Ensuring repeatability, reproducibility, and data integrity for regulatory acceptance
- Measurement uncertainty: Applying ISO 17025 principles and decision rules for accurate conformity assessment
- Prefilled syringes and autoinjectors: Key standards including ISO 11040 and ISO 11608 for injectable devices
- Container closure integrity testing (CCIT): USP <1207> strategies for sterile pharmaceutical packaging
- Transport simulation testing: Using ASTM D4169 to evaluate packaging performance in distribution
- Stability and shelf-life testing: Applying ICH Q1 guidelines for pharmaceutical and combination products
- On-body and advanced delivery devices: Testing considerations for complex and connected drug delivery systems