Presented by
Management Forum
Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course
Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.
★★★★★ "I was hoping to gain knowledge and be exposed to different interpretations of the guidelines. I acco... more (32)"
20-22 May 2026
+ 9-11 November 2026 »
from £1199
- Format: Live online
- CPD: 18 hours for your records
- Certificate of completion
Course overview
Master modern stability testing so that you can design, justify, and defend robust stability programmes fully aligned with the existing ICH Q1A–Q1F + ICH Q1E + ICH Q5C + EU/CPMP & WHO Guidelines and new ICH Q1(Draft).
As products become more complex and supply chains more global, it is crucial to stay up to date with the latest regulatory expectations, statistical approaches, and best practices for stability programme design.
Stability requirements continue to tighten, with the updated ICH Q1(Draft) bringing enhanced clarity around protocol justification, statistical modelling, pooling decisions, and data interpretation. Organisations that fail to modernise their stability programmes risk delays, failed submissions, and avoidable resource costs.
This course will keep you abreast of the latest developments, providing a complete, practical, and scientifically grounded approach for small molecules and biologics alike.
This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines.
Benefits of attending
- Understand the modernised principles and lifecycle concepts introduced in the new draft ICH Q1
- Learn how to design scientifically justified stability protocols for global submissions
- Gain confidence applying updated statistical tools, pooling rules, and regression approaches
- Strengthen your ability to interpret stability trends and identify true instability
- Master practical approaches to forced degradation and photostability studies
- Explore key degradation pathways and CQAs for proteins and other biologics
- Improve your ability to design reduced stability studies (matrixing, bracketing) compliantly
- Develop strategies for cold chain, frozen, and transport stability
- Enhance your ability to optimise shelf-life assignments and defend decisions to regulators
Who should attend?
- Development scientists
- Analytical chemists
- Stability programme leaders
- QC/QA specialists
- Regulatory affairs professionals
- CMC and technical development teams
- Formulation scientists
Popular with...
This course has proven particularly popular among our customers in these roles:
- QC Lead
- SCIENTIST
- Stability Coordinator
Paul Palmer
Paul R Palmer Ltd
Paul R Palmer is a Director / Pharmaceutical Consultant and a practicing EU / UK Qualified Person. He has over 35 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices.
Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerised systems, as well as the facilities and services to support each.
People and systems have always been a core focus, how to ensure best use, optimise and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.
Paul studied psychology as part of his MSc in 1993 and has always enjoyed observing the world around him with a curiosity that is rarely satisfied.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
20-22 May 2026
Live online
Course code 16280
- GBP 1,199 1,499
- EUR 1,679 2,099
- USD 1,931 2,399
Until 15 Apr
- 3 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
9-11 November 2026
Live online
Course code 16501
- GBP 1,199 1,499
- EUR 1,679 2,099
- USD 1,931 2,399
Until 05 Oct
- 3 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
Reviews of IPI's Stability Testing of Pharmaceuticals and Biopharmaceuticals training course
I was hoping to gain knowledge and be exposed to different interpretations of the guidelines. I accomplished this. It was a great opportunity to see the guidelines from a pharmaceutical perspective. I enjoyed seeing the tolerances the most, in terms of aspects that do not have specific guidelines but would be considered best practice. I have a positive opinion of the webinar, content and presentation. I also enjoyed the way it was clearly broken down into distinct parts, being able to see the exercises in advance [to help] pay particular attention on those parts, and apply what I have just been taught. The speakers were of high quality, and knowledgeable within the field delivering a highly engaging session.
Nov 10 2025
Kallum Smith 
Technical Scientist II - Laboratory Services, ConvaTec Ltd
Nov 11 2024
The webinar was very informative and the speaker had very good knowledge of the topic covered.
Lucy Barden
QC Analyst, Pets Choice Ltd.
Nov 13 2023
The content of the webinar was good, thorough. Paul answered any questions which I asked. With clear and concise reasoning. He made it easy to follow and not boring for someone with 4 years stability testing experience and basic knowledge. This has given me the tools I need to go back and hopefully improve the stability studies for the future. I enjoyed, I feel like I'm better prepared to justify the requirements of a stability study to my company. With an understanding of how to reduce costs and apply it to the industry I am in.
Elinor Jarvis
Quality Control Team Supervisor, Purolite Ltd
Nov 13 2023
Good speaker and content was very well explained. It met absolutely all my expectations.
Carmen Lopez
SCIENTIST, IMMUNOCORE
Nov 13 2023
I certainly have more information after the webinar which set a good foundation for further research. I liked the biopharmaceuticals topics and the packaging slides. These were of particular interest to me. I liked the idea of breakout rooms. A good amount of material was covered over the two days and I enjoyed the idea of breaking up the presentations with exercises.
Ananthi Ramachandran
Quality Control Manager , Rentschler ATMP Limited
Nov 14 2022
I not only learned about these topics, but I now have an idea on how to build on this outside of the course. There was a lot of information that was new to me, so at times it was difficult to digest. I will definitely take advantage of the slides provided to go back and review.
Tya Keys
Quality Control Technician, Hyaltech Ltd
Nov 14 2022
Very interesting and useful.
Stephane Hauduc
Senior Pharmaceutical Development and IP Manager, Destiny Pharma plc
Dec 1 2021
The webinar was really informative and speakers were great. I would highly recommend this course.
Valeria Ciapessoni 
Pharmaceutical Development Laboratory Analyst, Sintetica
Jul 12 2021
Very good.
Sylwia Andrzejewska 
Stability Coordinator CTM Analytics Austria, CTM Analytics, Valneva Austria GmbH
Dec 4 2019
There was great insight given into the background of stability and why it is so important. I would recommend this course to the rest of my team at work.
Yasmin Khimji
QC Analytical Scientist, MeiraGTx
Dec 4 2019
Really informative with a good overview of the guidelines and enough real-life examples and exercises to maintain engagement. I reinforced my understanding and gained confidence in designing stability studies efficiently and correctly.
Celia Garland
Medical Affairs Officer, Hameln Pharmaceuticals Ltd
Jul 3 2019
The content was great and covered a lot of areas and aspects. The presentation had a practical flow to the topics. The speaker was very keen on helping and answering any questions.
Holly Harvey
QC Stability Analyst, AstraZeneca Operations
Jul 4 2018
[The speaker was] friendly and helpful. A great course to further understanding of stability. Ray has a wealth of knowledge which was much appreciated.
Emma Grace Hill
Stability Coordinator, Perrigo
Jul 4 2018
Very good, informative, good pace.
Tim Liddy
QC Supervisor, Perrigo UK
Dec 5 2017
Well organised, good break structures, good amount of content.
Joanna Seiffert
Senior Principle Scientist, Trio Medicines
Dec 5 2017
Very well managed and presented course, thank you.
Jane Stevens
Stability Analyst, Torbay Pharmacy Manufacturing Unit
Dec 5 2017
Well run and presented course. Comprehensive material. Approachable speaker.
Lola Cascino
QC Scientist, G-Pharm Ltd
Jul 5 2017
Speaker knows his stuff. He answered all questions to the best of his ability. He was very nice and professional.
yetunde Bode
Regulatory Affairs Team Leader (UK Team), RPH Pharmaceuticals AB
Jul 5 2017
Very comprehensive but digestible.
Matthew Lait
Regulatory Affairs Officer, RPH Pharmaceuticals AB
Jul 5 2017
Informative, well presented, left me feeling clued up about stability, speaker very good at making you think in new ways to solve issues as well as real examples.
Liam O'Malley
R&D Scientist, TEVA
Dec 5 2017
Very good, well spaced breaks and good facilities. Good timings and content .
Ania Masters
Section head of stability, Bard Pharmaceuticals
Dec 5 2017
Excellent, content covered all expected aspects. Speaker was highly knowledgable.
James Murray
Medical Chemist, Mexichem UK Limited
Dec 5 2017
Covered all I needed.
Claire McGuinness
Research Chemist, Mexichem UK Limited
Dec 5 2017
Very knowledgeable and patient speaker, useful practical workshops, found content covered what I needed and introduced all relevant guidelines.
Joanna Seiffert
Senior Principle Scientist, Trio Medicines
Jul 5 2017
Really good.
Thundiyil Pintoo
R&D Analytical Laboratory Manager, Ginsana SA
Jul 5 2017
Very useful.
Jonathan Purdye
Chemistry Laboratory Manager, Torbay Pharmacy Manufacturing Unit
Dec 6 2016
Speakers were very helpful and experienced.
Lisa Cole
Senior Medical Information Officer, Fresenius Kabi
Jul 6 2016
The speaker was receptive to participant comments and questions, the content was organized and easy to follow, the materials distributed were pertinent and useful. Thank you for an interesting course!
Sandra Lickova
Product Development & Regulatory Affairs Manager, Dr. E. Graeub AG
Dec 6 2016
Useful course with applied knowledge information.
Gill French
Astrazeneca
Dec 6 2016
Ray is an expert in the field and his knowledge, enthusiasm and willingness to answer questions and target as we go have made the training interactive and enjoyable.
Blagovesta Tomova
Senior Scientist , LGC
Jul 6 2016
It is a good course about stability.
Maria Jose Fernandez 
CHEMO Espana SL
Jul 6 2016
The course was enjoyable with good content and the speakers were able to answer all my questions.
Mark Bell
Bard Pharmaceuticals
United Kingdom
- Torbay Pharmaceuticals
- Actavis Biologics Ltd
- Allergy Therapeutics
- AndersonBrecon Inc
- Astrazeneca
- AstraZeneca Operations
- Bard Pharmaceuticals
- Bio Products Laboratory Limited
- Calderdale and Huddersfield Solutions Ltd
- Charles River Gene Therapy Solutions
- Colonis Pharma
- ConvaTec Ltd
- ConvaTec UK Ltd
- Destiny Pharma plc
- Fresenius Kabi
- G-Pharm Ltd
- GW Pharma Ltd
- Hameln Pharmaceuticals Ltd
- Hyaltech Ltd
- IMMUNOCORE
- LGC
- LGC Ltd
- MeiraGTx
- Mexichem UK Limited
- Mylan
- Nelson's
- Nicobrand Limited
- Novartis Animal Health
- Perrigo
- Perrigo UK
- Pets Choice Ltd.
- Pharmaxo
- Pharmaxo Pharmacy Services Limited
- Protherics UK Limited
- Purolite Ltd
- QCNW
- Rentschler ATMP Limited
- RPH Pharmaceuticals AB
- sanofi
- SERB Pharmaceuticals
- Seven Seas Ltd
- Special Products Ltd
- TEVA
- Teva UK Ltd
- Torbay Pharmaceuticals
- Torbay Pharmacy Manufacturing Unit
- Trio Medicines
- Vericore Limited
- Veterinary Medicines Directorate
Sweden
- AstraZeneca
- BioInvent International
- Camurus AB
- Chemotechnique MB Diagnostics AB
- QPharma
- Recipharm
Switzerland
- Amal Therapeutics
- Ares Trading S.A - affilitate of Merck Serono SA
- Dr. E. Graeub AG
- Ginsana SA
- Sintetica
- Sintetica SA
Belgium
- CIRLAM bvba
- GlaxoSmithKline Vaccines
- Zoetis Belgium SA
Denmark
- ALK-Abelló A/S
- Bavarian Nordic
- Novo Nordisk A/S
France
- 3X Consultants
- Aptar France
- orphan europe
Germany
- Cheplapharm Arzneimittel GmbH
- Fresenius Kabi Deutschland GmbH
- STADA Arzneimittel AG
Netherlands
- Basic Pharma Manufacturing B.V.
- Curium Netherlands B.V.
- Synergy Health Utrecht BV
Austria
- Gebro Pharma GmbH
- Valneva Austria GmbH
Lebanon
- Benta S.A.L
- Benta SAL
Spain
- CHEMO Espana SL
- Laboratorios Almirall S A
United States of America
- Flare Therapeutics
- GlaxoSmithKline
Croatia
- Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
Czech Republic
- PRO.MED.CS Praha a.s.
El Salvador
- Touchlight DNA Services
Greece
- Elpen Pharmaceutical Co Inc
Hungary
- XELLIA Gyógyszervegyészeti Korlátolt Felelősségű Társaság
Ireland
- Allergan Pharmaceuticals (Ireland)
Israel
- Syqe Medical
Korea, Republic Of
- Samsung Bioepis
Latvia
- Joint Stock Company “Olpha”
Poland
- Polpharma Biologics
Saudi Arabia
- Saudi Food and Drug Authority
Singapore
- GSK
Slovenia
- LEK Pharmaceuticals d.d.
Run Stability Testing of Pharmaceuticals and Biopharmaceuticals Live online for your team
2 days
Typical duration
Pricing from:
- GBP 1,000
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
