Q1 Scientific Webinars

Following feedback from customers we have created the Q1 Scientific webinar series. This series is designed for those working in for pharmaceutical and medical device companies with responsibility for designing and managing stability studies.

Upcoming webinar: Stability study design for optimised regulatory approval

How do you optimise stability study design for regulatory approval? Join us for a webinar featuring guest speaker Kate Coleman, VP Regulatory Affairs, Quality and Compliance (Principal Consultant) at Arriello to unlock the secrets of regulatory success.

Date: Wednesday 22nd of May 2024

Time: 2 pm (GMT)

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In this engaging webinar, we’ll explore the critical aspects of stability study design and execution across the entire product lifecycle. Whether you’re an analytical expert, a quality specialist, or a regulatory professional, this session is tailored for you.

Here’s what we’ll cover:

  1. Regulatory requirements:
    • Understand the specific stability requirements for clinical trial applications and marketing authorisation applications.
  2. Navigating manufacturing changes:
    • Explore the challenges posed by manufacturing changes during clinical development.
    • Discover strategies to maintain stability study integrity amidst these changes.
  3. Aligning commercial strategy with stability:
    • Why is stability strategy alignment crucial for future commercial success?
    • Practical insights on ensuring harmony between stability and commercial goals.

At the end of the webinar, you will have the opportunity to ask Kate Coleman your specific questions during a live Q&A session.

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Kate Coleman ArrielloMeet our guest speaker: Kate Coleman

Kate Coleman is the VP of Regulatory Affairs, Quality and Compliance at Arriello and has over 20 years of experience in the Pharmaceutical Industry across several platforms including Biologics, Sterile Fill Finish, Vaccines, and Oral Dose. Kate is a Qualified Person, Principal Consultant, Lead Auditor and an SME in several areas including Quality Control and Stability.

Kate’s wealth of knowledge will illuminate the intricacies of stability study design and its impact on regulatory success.

Why join this webinar?

  • Insights: Gain practical insights from an industry expert.
  • Q&A Session: Have burning questions? Ask Kate Coleman during the live Q&A segment.
  • Networking: Connect with fellow professionals managing stability studies.

How can Q1 Scientific support stability study design?

This webinar is hosted by Q1 Scientific. If you are looking for a secure, reliable and cost-effective way to store your pharmaceutical and medical device products under various environmental conditions, you need Q1 Scientific, the leader in outsourced stability storage. Operating from state-of-the-art facilities in Ireland and Belgium, Q1 Scientific helps improve the speed of new drugs and medical devices reaching the marketplace along with saving companies the expense of building and monitoring their own storage chambers. With full equipment validation, tightly controlled conditions and continuous sample monitoring Q1 Scientific is not just a storage provider, it is your trusted partner for stability storage excellence.

You focus on breakthroughs, we handle the logistics. Your breakthroughs deserve the right conditions. 

Talk to Q1 Scientific about stability storage

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 insights into stability study design and what it means for you. During the webinars, our presenters share their experience and address 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

Navigating new regulations in biobanking for clinical studies and research projects
Wed, Oct 4 2023 at 14:00

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Forced degradation studies
Wed, May 17 2023 at 15:00

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Managing drug-related degradation products
Tues, March 21 2023 at 14:00

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Registration stability case study
Wed, May 7 2022 at 14:00

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In-use stability
Thurs, Apr 7 2022 at 14:00

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Stability Studies throughout the Product Life Cycle
Thurs, Oct 21 2021 at 14:00

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Designing a Registration Stability Study from Scratch
Thurs, Sept 2 2021 at 14:00

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Trending Stability Data
Thurs, Apr 15 2021 at 14:00

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Shelf Life Evaluation and Extrapolation
Thurs, Feb 25 2021 at 14:00

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Temperature Excursion and Cycling Studies
Wed, Oct 21 2020 at 14:00

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Biopharmaceutical Stability Studies
Wed, Sep 16 2020 at 14:00

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Stability Study Design – Bracketing and Matrixing
Wed, Aug 12 2020 at 14:00

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Navigating new regulations in biobanking for clinical studies and research projects

Watch Prof. Jonathan Douxfils, CEO and Co-Founder of QUALIblood discuss the:

  • Importance of biobanking in advancing medical research and personalized treatments.
  • Need for regulations to ensure ethical and legal practices in biobanking.
  • Latest regulations impacting biobanking for clinical studies and research projects including their impact on clinical studies, changes researchers may need to implement in their projects and potential challenges in complying with new regulations.

After graduating in pharmaceutical sciences in 2011, Prof. Jonathan Douxfils obtained his PhD in biomedical and pharmaceutical sciences in 2015. In 2017 he launched QUALIblood, a Contract Research Organization (CRO) aiming to provide industries, hospitals, and universities with central laboratory services for blood investigations. His company employs 7 people actively working on pre-clinical, phase-1, phase-2, and phase-3 clinical trials in several pharmaceutical fields. In 2018, he gained an academic position at the University of Namur in Belgium where he teaches pharmacology to students in bachelor and master’s degrees. He also provides continuing education for health professionals, especially for pharmacists and clinical biologists. In 2019, he received the Eberhard F. Mammen Young Investigator Award for his research on the development of a new algorithm based on thrombin generation to assess hormone-related prothrombotic changes. In 2020, he was nominated as the “Namurois of Year”, category Sciences, a prize rewarding people in the Namur community for their engagement and their scientific discovery. In 2023, he was appointed Professor by the University of Namur.

Navigating new regulations in biobanking for clinical studies and research projects
Wed, Oct 4 2023 at 14:00

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Forced degradation studies

Listen to Dr. Mark Powell as he discusses forced degradation studies. There is currently no harmonised guidance on the conduct of forced degradation studies. This webinar summarises scientific principles, industry best practice and available guidance (including the ANVISA RDC No. 53 and the accompanying guidance note).

Topics covered include:

  • The science of forced degradation studies
    • Modes of degradation
    • Reaction rate
  • Regulatory expectations
  • Industry best practice

Forced degradation studies
Wed, May 17 2023 at 15:00

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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.Dr Mark Powell

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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