Q1 Scientific Webinars
Following feedback from customers we have created the Q1 Scientific webinar series. This series is designed for those working in the pharmaceutical, medical device, food and cosmetics sectors with responsibility for designing and managing stability studies.
Register for the next Q1 Scientific webinar
Join Dr. Mark Powell as he discusses shelf life evaluation and extrapolation on Thursday 25th February at 2pm.
This webinar explains how to set a retest period for a drug substance or shelf life for the drug product. It also describes how extrapolation can be applied to propose a retest period or shelf life for a drug product that extends beyond the period covered by real-time stability data. It covers regulatory guidance, poolability of stability data and appropriate statistical models for shelf-life evaluation.
Topics covered include:
- Overview of ICH Q1E – Evaluation for Stability Data
- Shelf life extrapolation
- Statistical background to ICH Q1E
- Evaluating poolability of stability data – analysis of covariance
- Examples – potency and impurity trends
Did you miss our previous webinars?
If you missed our live webinars then the good news is that we recorded them all for you. You can now catch-up online using the links below.
All our webinars aim to provide an insight into stability study design and what it means for you. During the webinars Dr. Mark Powell shares his experience and addresses key questions.
Stability Study Design – Bracketing and Matrixing
Wed, Aug 12 14:00
Biopharmaceutical Stability Studies
Wed, Sep 16 14:00
Temperature Excursion and Cycling Studies
Wed, Oct 21 14:00
Can we help you?
Q1 Scientific offer a complete stability sample management service and can organise and secure your sample inventory. We offer:
- ICH compliant and non-ICH stability storage chambers which are monitored 24/7, 365 days of the year and have built-in safeguards
- Custom conditions to meet the specific storage requirements of any project
- Fully validated systems and equipment
- A monitoring and alert system and emergency back-up generators
- A complete stability study sample management service with sample receipt and return documentation along with notifications for scheduled pulls for testing
- A secure cloud-based documentation solution for your sample management
- Temperature controlled transfer and transport
- Access to a team of highly experienced pharmaceutical industry experts who are trained in recording cGMP compliant data
With tightly controlled temperatures and humidity rates at our spacious cGMP facility, we can store and manage any samples over the full life cycle of your stability plans.
To discuss how we can help you with your stability storage contact the team today.
Register to hear about future webinars
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