Join Dr. Mark Powell on Tuesday 21st March at 2 pm (GMT) for our next free webinar where he discusses managing drug-related degradation products
Drug-related degradation products are often the shelf-life limiting attribute during stability studies. This webinar details current regulatory guidance and strategies for justifying impurity levels greater than the default limits in ICH Q3B. Impurity guidance for biologics is less well developed than for chemical drugs, but relevant guidance will be covered. The webinar goes on to address common problems with stability-indicating test methods and challenges in trending impurities, including dealing with data above the method’s limit of detection but below the limit of quantitation.
Topics covered include:
- Introduction and definitions
- Regulatory expectations for ordinary and genotoxic impurities
- Strategies for impurity justification/qualification
- Trending degradation products – how to avoid common problems
At the end of the webinar, you will have the opportunity to ask Dr. Mark Powell your specific questions during a live Q&A session.
Register online to join us.
Why attend this webinar on managing drug related degradation products?
All our webinars aim to provide insights into stability study design and what it means for you. During the webinars, Dr. Mark Powell shares his experience and addresses key questions.
These free webinars are designed for:
- Stability Programme Managers / Staff
- Development Project Managers / Scientists
- QC Scientists
- Quality Assurance professionals
- Qualified Persons (EU)
- Regulatory Affairs professionals
About the speaker Dr. Mark Powell
Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years of 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 offers 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.
Have you seen our previous webinars?
If you missed our previous live webinars then the good news is that we recorded them all for you. You can now catch up online through our dedicated webinar page.
Register to hear about future webinars
To be the first to find out about future Q1 Scientific webinars join our mailing list.