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Controlled Temperature Chambers: Qualification, Mapping & Monitoring￼
May 18, 2022 @ 10:00 AM – 11:00 AM
Two industry experts bring combined experience of over four decades in qualification, mapping, and monitoring to discuss best practices for controlled-temperature chambers in GxP applications.
Regulatory requirements change slowly, but industry practice is increasingly affected by two key factors: technological advances and quality requirements. The intersection between long-standing regulations and new technology is often found in best practice guides published by accrediting bodies or professional associations like the International Society of Pharmaceutical Engineers (ISPE).
These organizations are able to leverage their members’ subject matter expertise in GxP compliance efficiently and then disseminate that information broadly. The basic goal of good practice guides is sharing knowledge to support a competitive and compliant life science industry. The highest goal is ensuring the safety, quality, and efficacy of products.
One of the most common concerns in GxP quality is maintaining the temperature of laboratory and manufacturing storage environments. Deviations in temperature can have dramatic consequences on product quality, making management of controlled-temperature chambers (CTCs) a critical practice from R&D to distribution.
In this webinar, Vaisala’s Paul Daniel is joined by Genesis AEC’s Validation Director Nathan Roman to discuss their industry experience with controlled-temperature chambers and their personal contributions to the recent revision of the ISPE’s “Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring“. Join the discussion to learn how industry is solving old challenges in new ways.
- History of Good Distribution Practice & the importance of mapping
- Sensor choices for mapping and monitoring
- Calibration and qualification
- Active vs passive CTCs
- Best practice for documenting CTC qualification
- Updates to the ISPE’s CTC Good Practice Guide
We welcome your questions in advance and will leave time during the webinar for Q&A.
If you cannot attend the live session, we will send all registrants the recording.