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.
View previous Q1 Scientific stability study 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.
These webinars are designed for:
- Stability Programme Managers / Staff
- Development Project Managers / Scientists
- QC Scientists
- Quality Assurance professionals
- Qualified Persons (EU)
- Regulatory Affairs professionals
Managing drug-related degradation products
Tues, March 21 2023 at 14:00
Registration stability case study
Wed, May 7 2022 at 14:00
In-use stability
Thurs, Apr 7 2022 at 14:00
Stability Studies throughout the Product Life Cycle
Thurs, Oct 21 2021 at 14:00
Designing a Registration Stability Study from Scratch
Thurs, Sept 2 2021 at 14:00
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
Managing drug-related degradation products
Listen to Dr. Mark Powell as 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
This webinar also contains a brief introduction to our new cGMP facility in Belgium from our General Manager, Cecile Jacoby.
Managing drug-related degradation products
Tues, March 21 2023 at 14:00
Registration stability case study
Join Dr. Mark Powell as he runs through a registration stability case study. Registration stability is a key component of a marketing authorisation application or new drug application. This webinar covers the general considerations for registration stability, including EMA and US FDA requirements, and presents a case study for a solid oral dosage form. It also covers:
- Overview of regulatory requirements
- Attributes to measure and frequency
- Managing stability chamber excursions and pull schedules
- Case study: registration stability for a solid oral drug product
Registration stability case study
Wed, May 7 2022 at 14:00
In-use stability
The requirements for in-use stability for multi-dose medicinal products are not well described in harmonised regulatory guidance. This webinar explains the current regulatory landscape, the quality considerations for in-use studies and practical tips on scientifically sound study designs.
Topics covered include:
- In-use stability testing in context
- EMA guidance on in-use stability testing
- Expectations of other regulatory bodies
- Physical, chemical and microbiological risks for multi-dose products
- Requirements for solid oral dosage forms
- Study design
In-use stability
Thurs, Apr 7 2022 at 14:00
Stability Studies throughout the Product Life Cycle
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 also explains the purpose of each study and highlights 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
Stability Studies throughout the Product Life Cycle
Thurs, Oct 21 2021 at 14:00
Designing a Registration Stability Study from Scratch
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
Trending Stability Data
Pharmaceutical regulators have made it clear that the same investigation approach should be adopted for out-of-trend (OOT) results as for out-of-specification (OOS) results. However, regulators offer little guidance on identifying OOT data. For OOT results to be identified promptly during stability studies, data must be continuously trended in some way. The problem is that trends are often not obvious during the early phases of a stability study. This webinar offers some practical approaches for the continuous trending of stability data and covers:
- Regulatory expectations for OOT results
- When is a result OOT?
- Identifying OOT results
- Regression control chart
- By-time-point method
- Slope control chart method
Trending Stability Data
Thurs, Apr 15 2021 at 14:00
Shelf Life Evaluation and Extrapolation
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
Shelf Life Evaluation and Extrapolation
Thurs, Feb 25 2021 at 14:00
Temperature Excursion and Cycling Studies
Temperature excursions during shipment can cause the recall of drug product lots, leading to delays in supply and loss of revenue. Data from a well-conducted temperature excursion and/or cycling study can be used to justify such excursions. There is currently no harmonised guidance dealing with the impact of temperature excursions during distribution or the effect of freeze/thaw cycles on liquids and semi-solids. This webinar reviews best practice in these areas. Topics covered include:
- Overview of regulatory guidance
- Temperature excursion risks to physical and chemical product stability
- Evaluating possible excursions using supply chain knowledge
- Temperature excursion studies
- Thermal cycling studies
- Transportation control strategy
Temperature Excursion and Cycling Studies
Wed, Oct 21 2020 at 14:00
Biopharmaceutical Stability Studies
Stability is a particular problem for biopharmaceutical products because the physical and chemical stability of peptides and proteins are often very sensitive to storage and transportation conditions. The purpose of this webinar is to explain the typical approach for the design of a stability study for biologics. The webinar also covers the specific challenges of these product types as well as typical degradation mechanisms. Topics covered include:
- Overview of ICH Q5C – Stability testing of biotechnological/biological products
- Specific stability challenges for biologics
- Protein and peptide degradation pathways
- Evaluating stability – typical tests
- In-use stability
- Stability after reconstitution
Biopharmaceutical Stability Studies
Wed, Sep 16 2020 at 14:00
Stability Study Design – Bracketing and Matrixing
Stability programmes are a costly undertaking, especially for products that have multiple strengths and packaging configurations, where a full study design will require every configuration to be evaluated for three registration batches at each time point. The use of reduced study designs such as bracketing and matrixing can reduce the cost of formal stability studies. This webinar describes when the use of such approaches is allowable, together with their associated benefits and risks. Topics covered include:
- Overview of ICH Q1D – Bracketing and Matrixing Designs
- Bracketing study designs
- Bracketing study risks
- Matrix study designs
- Matrix study risks
- Combined bracketing and matrix study designs
- Summary of risks and benefits
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.
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