e-Learning: Global Stability
Stability testing for chemical and biological products in the ICH region and beyond
- Up-to-date expert knowledge
- Global requirements + update on revision ICH Q1
- Flexibility in location and timing
- You establish your own learning speed
- Officially certified: ISO 9001 + 21001
e-Learning
Ab
490,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 490,-€ zzgl. MwSt.
The fee for a single account that is valid for 90 days is €490 (excluding German VAT). You can access the modules/single lessons as often as you want during this time. You will be awarded a certificate of completion at the end.
Period:
Available anytime
You can find your e-learning access in your customer portal; it is valid for 90 days from the date of invoicing. During this time, you can access the modules as often as you like.
Buchungsdetails
e-Learning
Ab
490,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 490,-€ zzgl. MwSt.
The fee for a single account that is valid for 90 days is €490 (excluding German VAT). You can access the modules/single lessons as often as you want during this time. You will be awarded a certificate of completion at the end.
Period:
Available anytime
You can find your e-learning access in your customer portal; it is valid for 90 days from the date of invoicing. During this time, you can access the modules as often as you like.
Global Stability: This e-Learning provides a comprehensive introduction to global stability testing for pharmaceutical products (chemical and biological products). Including an update on revision of the guideline ICH Q1.
Your speaker
Dr. Christina Juli
Boehringer Ingelheim International GmbH
Biberach an der Riss, GERMANY
Head of CMC, CCM RA Office NBE
Dr Christina Juli studied pharmacy at the University of Wuerzburg, Germany. After her PhD thesis in…
Your speaker
Dr. Christina Juli
Boehringer Ingelheim International GmbH
Biberach an der Riss, GERMANY
Head of CMC, CCM RA Office NBE
Dr Christina Juli studied pharmacy at the University of Wuerzburg, Germany. After her PhD thesis in the fields of pharmaceutical chemistry, in 2012, she joined ratiopharm GmbH in Ulm, Germany and started her professional career as Senior Manager in the department of EU Regulatory Affairs Generic Maintenance.
From 2018 to 2025, she was working at the manufacturing site for biopharmaceuticals in Biberach, Germany as Head of CMC Management CMB where she focused on the CMC development for biologics for the contract manufacturing business of Boehringer Ingelheim.
In her current role as Head of CMC RA Office NBE, she focuses on the CMC development for biologics and is responsible for CMC regulatory topics of development projects, products, and strategic regulatory projects.
Beyond that she is an active participant of several industry groups such as the BioPhorum Operations Group (Post Approval Strategy and Regulatory Governance working groups) or EFPIA.
What to Expect
- Basics and regulatory requirements
- Factors influencing stability
- Stability testing requirements
- Bracketing and matrixing
- Storage conditions
- Shelf life/re-test and extrapolation
- Dossier structure
- Impact of changes on stability
- Global stability program
- Challenges for biological products
Who Should Attend
This e-Learning is designed for professionals working in pharmaceutical development, regulatory affairs, quality assurance, or CMC management who are involved in or responsible for stability-related activities.
It is equally valuable for anyone seeking a structured and up-to-date overview of global stability requirements.
Objective of the Event
This e-Learning (newly created in Q1-2026) provides a comprehensive introduction to global stability testing for pharmaceutical products.
It includes an update on the revision of the ICH Q1 guideline and what it means for your day-to-day work.
Across 10 self-paced modules combining video, audio, and (interactive) text elements, you will explore the regulatory landscape, key stability concepts, and the requirements that apply throughout a product's entire lifecycle.
By completing this course, you will gain a solid understanding of how stability studies are designed, conducted, and evaluated to ensure that medicines remain safe and effective for patients worldwide.
Your Benefit
The e-Learning format allows you to set your own schedule and pause at any time to review individual lessons, thereby avoiding time pressure.
You will benefit from the long-term experience of Dr Christina Juli and gain
- a solid understanding of global regulatory requirements for stability testing, including ICH guidelines and region-specific frameworks (EU, USA).
- practical knowledge on stability study design: from storage conditions and testing frequencies to bracketing, matrixing, and shelf-life determination.
- insight into the specific challenges of biological products and advanced therapies (ATMPs).
- awareness of the upcoming finalisation of the revision of the ICH Q1 guideline and what it means for your day-to-day work.
Programme
- Product stability basics
- Purpose of stability testing
- Needs and aims of stability testing
- New Chemical Entities (NCEs) vs. New Biological Entities (NBEs)
- Regulatory requirements
- ICH guidelines
- Revision ICH Q1 "Stability Guideline"
- Additional guidelines
After having passed this module, you explored the fundamentals of product stability, the differences between NCEs and NBEs, and the key ICH guidelines alongside the upcoming changes introduced by the Draft ICH Q1 Guideline.
- Factors influencing stability
- Formulation development and stability
- Container-closure and finished product stability
- Transportation
- Human factor - influence on stability
- Adverse effects of stability
After having passed this module, you explored how drug substance properties, formulation, excipients, manufacturing processes, and container-closure systems influence product stability, and how environmental factors and human handling contribute to degradation.
- Stability studies
- Long-term and accelerated studies
- Intermediate studies
- Stability studies during development and life cycle
- Forced degradation studies (stress testing)
- Forced degradation studies during development and life cycle
- Photostability studies (ICH Q1B)
- Transportation studies
- In-use stability studies
- Stability budget
After having passed this module, you explored the purpose and scope of various stability study types - from long-term and accelerated to photostability and in-use studies - and how they support product development, lifecycle management, and the definition of shelf life, storage conditions, and handling guidelines.
- Bracketing and matrixing designs (ICH Q1D)
- Bracketing
- Matrixing
- Bracketing and matrixing designs - CAVE
After having passed this module, you learned the principles of bracketing and matrixing per ICH Q1D, including when reduced stability designs are appropriate, and how to evaluate their advantages, limitations, and regulatory considerations.
- Declaration of storage conditions
- Required stability data for marketing authorisation
- Storage conditions (ICH Q1A)
- Label statements
- Other specific storage statements
After having passed this module, you learned how storage conditions are defined and justified based on stability data, what regulatory requirements apply for marketing authorisation, and how storage statements, in-use conditions, and expiration dates are derived and reflected on product labelling.
- Definition - shelf life
- Shelf life extension during clinical trial
- Start of the shelf life of the drug product
- Definition re-test
After having passed this module, you learned how re-test periods and shelf life are defined and justified based on long-term stability data, and when extrapolation of stability data is scientifically acceptable according to ICH Q1E using statistical and non-statistical approaches.
- Common Technical Document (CTD) Module 3 "Quality"
- Stability documentation in CTD Module 3
- Further drug substance and drug product CTD sections affected
- Post-approval stability requirements
After having passed this module, you learned how stability information is structured within the Common Technical Document (CTD), particularly in sections 3.2.S.7 and 3.2.P.8, and how stability data supports regulatory filings from clinical submissions through to post-approval commitments and renewals.
- How changes affect global stability requirements
- Stability-relevant guidelines
- EU Variation Guideline
- Points to consider
After having passed this module, you learned which changes can impact a product's stability profile, what constitutes a "significant change" in regulatory terms, and which post-approval variations typically trigger the need for additional stability studies.
- Climatic zones
- WHO stability requirements
- Additional challenges
After having passed this module, you learned how global climatic zones influence stability study design, what WHO requirements apply to APIs and finished products, and which key challenges arise in global stability programmes, such as country-specific requirements and limitations of reduced study designs.
- Stability testing of biological products
- Challenges for stability of biologics
- Causes and prevention of instability
- Additional challenges
- Summary of stability studies (biologicals - example)
After having passed this module, you learned about the unique stability challenges of biological and biotechnological products, the principles of stability testing according to ICH Q5C, and how intrinsic, extrinsic, and process-related factors influence the stability, safety, and quality of biologics.
Examples including solutions.
Examples including solutions
Module 1: Basics and regulatory requirements
Module 1: Basics and regulatory requirements
- Product stability basics
- Purpose of stability testing
- Needs and aims of stability testing
- New Chemical Entities (NCEs) vs. New Biological Entities (NBEs)
- Regulatory requirements
- ICH guidelines
- Revision ICH Q1 "Stability Guideline"
- Additional guidelines
After having passed this module, you explored the fundamentals of product stability, the differences between NCEs and NBEs, and the key ICH guidelines alongside the upcoming changes introduced by the Draft ICH Q1 Guideline.
Module 2: Factors influencing stability
Module 2: Factors influencing stability
- Factors influencing stability
- Formulation development and stability
- Container-closure and finished product stability
- Transportation
- Human factor - influence on stability
- Adverse effects of stability
After having passed this module, you explored how drug substance properties, formulation, excipients, manufacturing processes, and container-closure systems influence product stability, and how environmental factors and human handling contribute to degradation.
Module 3: Stability testing requirements
Module 3: Stability testing requirements
- Stability studies
- Long-term and accelerated studies
- Intermediate studies
- Stability studies during development and life cycle
- Forced degradation studies (stress testing)
- Forced degradation studies during development and life cycle
- Photostability studies (ICH Q1B)
- Transportation studies
- In-use stability studies
- Stability budget
After having passed this module, you explored the purpose and scope of various stability study types - from long-term and accelerated to photostability and in-use studies - and how they support product development, lifecycle management, and the definition of shelf life, storage conditions, and handling guidelines.
Module 4: Bracketing and matrixing
Module 4: Bracketing and matrixing
- Bracketing and matrixing designs (ICH Q1D)
- Bracketing
- Matrixing
- Bracketing and matrixing designs - CAVE
After having passed this module, you learned the principles of bracketing and matrixing per ICH Q1D, including when reduced stability designs are appropriate, and how to evaluate their advantages, limitations, and regulatory considerations.
Module 5: Storage conditions
Module 5: Storage conditions
- Declaration of storage conditions
- Required stability data for marketing authorisation
- Storage conditions (ICH Q1A)
- Label statements
- Other specific storage statements
After having passed this module, you learned how storage conditions are defined and justified based on stability data, what regulatory requirements apply for marketing authorisation, and how storage statements, in-use conditions, and expiration dates are derived and reflected on product labelling.
Module 6: Shelf life/re-test and extrapolation
Module 6: Shelf life/re-test and extrapolation
- Definition - shelf life
- Shelf life extension during clinical trial
- Start of the shelf life of the drug product
- Definition re-test
After having passed this module, you learned how re-test periods and shelf life are defined and justified based on long-term stability data, and when extrapolation of stability data is scientifically acceptable according to ICH Q1E using statistical and non-statistical approaches.
Module 7: Dossier structure
Module 7: Dossier structure
- Common Technical Document (CTD) Module 3 "Quality"
- Stability documentation in CTD Module 3
- Further drug substance and drug product CTD sections affected
- Post-approval stability requirements
After having passed this module, you learned how stability information is structured within the Common Technical Document (CTD), particularly in sections 3.2.S.7 and 3.2.P.8, and how stability data supports regulatory filings from clinical submissions through to post-approval commitments and renewals.
Module 8: Impact of changes on stability
Module 8: Impact of changes on stability
- How changes affect global stability requirements
- Stability-relevant guidelines
- EU Variation Guideline
- Points to consider
After having passed this module, you learned which changes can impact a product's stability profile, what constitutes a "significant change" in regulatory terms, and which post-approval variations typically trigger the need for additional stability studies.
Module 9: Global stability programs
Module 9: Global stability programs
- Climatic zones
- WHO stability requirements
- Additional challenges
After having passed this module, you learned how global climatic zones influence stability study design, what WHO requirements apply to APIs and finished products, and which key challenges arise in global stability programmes, such as country-specific requirements and limitations of reduced study designs.
Module 10: Challenges for biological products
Module 10: Challenges for biological products
- Stability testing of biological products
- Challenges for stability of biologics
- Causes and prevention of instability
- Additional challenges
- Summary of stability studies (biologicals - example)
After having passed this module, you learned about the unique stability challenges of biological and biotechnological products, the principles of stability testing according to ICH Q5C, and how intrinsic, extrinsic, and process-related factors influence the stability, safety, and quality of biologics.
Case studies
Case studies
Examples including solutions.
Case studies
Case studies
Examples including solutions
Trailer
Downloads
Request the documents using our form.
Brochure
Whitepaper_Stability-Testing-of-Drug-Products
Weitere Informationen
Principles of the e-Learning
The e-learning program 'Global Stability' comprises ten didactic modules that include videos in which the expert Dr Christina Juli shares her expertise with you. You can also download and print the corresponding presentation documents.
Each module comprises additional documents (links, guideline texts, etc.) as well as interactive exercises and questions, which help you practice and apply your newly gained knowledge. Each module ends with an online-test/quiz.
It is estimated that completing the e-learning course will take approximately 5 hours. The e-learning program should be completed within three months.
Once you have completed all modules and successfully passed the assessments, you will receive a certificate of completion, which serves as proof of training, e.g., for audits or inspections. The certificate and learning assessments are generated based on an automated, non-individualized multiple-choice test.
The e-learning course can be booked either as a standalone program or as preparation for another advanced training course that delves deeper into a specific topic. If you book as part of a training bundle, you’ll benefit from an attractive discount.
How does it work?
- 1. You sign up for the e-learning course on our website.
- 2. You will receive an email with your login credentials for the customer portal and will then be redirected to the learning platform.
- 3. You start at your own pace and complete the respective learning modules.
- 4. You finish each module with a learning assessment.
- 5. Upon successful completion of all modules, you will receive a certificate, which you can conveniently download directly from the learning platform.
Please try out the demo versions of our e-learning programs free of charge to get an idea of our learning environment.
For more details, please visit our Website
Attractive corporate offers
Would you like to train multiple employees, or do you need a flexible annual quota to provide new hires with the foundational knowledge they need for their roles at any time?
No problem - we also offer attractive group accounts!
Or would you like to offer the e-learning courses on your company’s internal learning platform?
That’s possible too: You can also purchase our e-learning courses as SCORM files, which can be easily integrated into your company’s internal learning platform.
Contact us directly at b.wessels@forum-institut.de. We’d be happy to provide you with a customised quote.
The participation fee includes comprehensive documentation, along with the option to download these materials.
The e-learning course is available to you for 90 days.
This is what distinguishes this event
Modules
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Further Information
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