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 our next webinar
Join Dr. Mark Powell as he looks at the various stability studies conducted from the start of pharmaceutical development to the manufacture of marketed product. Dr. Mark Powell will also explain the purpose of each study and highlight some of the potential pitfalls.
Topics covered include:
• Aims of stability evaluation
• The effect of environmental factors and the primary pack
• API stability
• Excipient compatibility
• Prototype stability (including accelerated stability using the ASAP model and stress stability studies)
• Bulk hold studies
• In-use stability
• Registration stability
• Shipping excursion studies.
View our last Q1 Scientific webinar
Register now to view our recent webinar where Dr. Mark Powell discussed designing a registration stability study from scratch.
The aim of this webinar was to provide guidance on the design of long-term stability studies in support of a MAA or NDA. As well as describing the general requirements for different dosage forms, differences in expectations between EU and US regulators were highlighted. Depending on the dosage form and pack type, certain risks require mitigation prior to registration batch manufacture and stability set-down: these were also discussed. Confidence in test methods and a plan for low-level impurity data reporting are also important elements. Finally, study designs were discussed, including different product configurations and requirements for registration in Climatic Zones III and IV.
Topics covered included:
- Regulatory expectations for different dosage forms
- Product knowledge
- Test method and data reporting considerations
- Study design
- Different strengths/primary pack configurations
- Considerations for global registration
Designing a Registration Stability Study from Scratch
Thurs, Sept 2 2021 at 14:00
Did you miss the previous Q1 Scientific 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.
Trending Stability Data
Thurs, Apr 15 2021 at 14:00
Shelf Life Evaluation and Extrapolation
Thurs, Feb 25 2021 at 14:00
Temperature Excursion and Cycling Studies
Wed, Oct 21 2020 at 14:00
Biopharmaceutical Stability Studies
Wed, Sep 16 2020 at 14:00
Stability Study Design – Bracketing and Matrixing
Wed, Aug 12 2020 at 14:00
About the speaker Dr. Mark Powell
Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a Senior Analytical Chemist.
Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016. He has worked at a senior level in a number of companies with responsibility for analytical development and equipment qualification. In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programmes as well as establishing collaborations with academia and instrument manufacturers.
In 2013, he set up his own company to provide training and consultancy services to the pharmaceutical industry. His consultancy work has involved, amongst other things, managing the analytical aspects of pharmaceutical development programmes and conducting data integrity audits. He is in demand as a trainer in topics such as pharmaceutical development, chromatography, spectroscopy, dissolution testing, data integrity, control of impurities, technical writing, stability/stress studies and sample preparation.
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 with 24/7, 365 days of the year monitoring and 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
To be the first to find out about future Q1 Scientific webinars join our mailing list.