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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.

★★★★★ "The content of the webinar was good, thorough. Paul answered any questions which I asked. With clear... more (31)"

24-27 February 2025
+ 21-22 July 2025, 10-11 November 2025 »
from £1299

Need help? Enrol/reserve

Format: Live online
CPD: 12 hours for your records
Certificate of completion

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Course overview

By attending this intensive two-day seminar, delegates will learn how to:

Carry out appropriate stability studies and manage stability samples and facilities
Design stability studies that are suitable for global marketing
Increase the likelihood of studies receiving regulatory approval
Save resources on stability testing with potential large financial savings

A series of practical exercises will take place throughout the programme to give participants the opportunity to apply their knowledge under the guidance of our experienced trainers.

Please note that we are delighted to confirm that this course will now also include particulars of the stability of biopharmaceuticals.

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. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

Benefits of attending

Comply with stability requirements for new and existing drug substances, products and line extensions
Gain knowledge on storage tests, conditions and protocols
Learn how to design highly efficient protocols for global marketing with potentially large financial savings
Discover how to manage stability samples and facilities
Understand what stability testing is required following changes to a product
Discuss data treatment, shelf-life assignment and extrapolation

Who should attend?

Personnel involved in:

Stability testing of pharmaceuticals and biopharmaceuticals
The design of stability protocols
The management of stability samples and facilities
The development of pharmaceuticals which require stability testing
The production of regulatory documents which include stability data
Quality assurance

Enrol/reserve

This course will cover:

Background to stability testing and guidelines

The rationale for stability testing
Relevant guidelines

Storage tests, conditions and protocols

Tests for drug substance and product types
Storage conditions and periods required
Typical protocols
Developing global stability protocols
In-use testing

Exercise 1: designing a simple stability protocol

Management of stability samples and facilities

Sample management
Validation of storage facilities
How to treat excursions from condition

Requirements for existing products, line extensions and variations

Guidelines available (ICH, EU and USA)
Requirements for active ingredient
Requirements for product
Requirements for variations to marketed products

Exercise 2: designing a more complex stability protocol

Data treatment, shelf-life assignment and extrapolation

When is statistical treatment required?
How much extrapolation beyond real-time data is allowable?
Presentation of data in submissions
Setting shelf-life specifications

Exercise 3: data treatment

Light stability testing

ICH Q1B guidelines
Light sources
Required exposure
Problems in light testing

Packaging considerations

Guidelines
Requirements when changing packaging
Demonstrating equivalence
Permeation considerations
Interaction studies

Exercise 4: packaging

Biopharmaceutical stability

ICH Q5C and regulatory guidance
Complexity associated with biopharmaceuticals
Stability-indicating assays for biopharmaceuticals
Stability considerations for new modalities

Biopharmaceutical stability

ICH Q5C and regulatory guidance
Complexity associated with biopharmaceuticals
Stability-indicating assays for biopharmaceuticals
Stability considerations for new modalities

Sundry considerations

Bulk stability
Manufacture in zones III/IV to be sold in zone I
Out-of-specification in stability

Matrixing and bracketing stability studies

Bracketing designs
Matrixing designs
ICH Q1D guidelines
What is acceptable for bracketing and matrixing?

Exercise 5: designing efficient stability protocols

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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.

More details

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

24-27 February 2025

Live online

13:30-17:15 UK (London) (UTC+00)
14:30-18:15 Paris (UTC+01)
08:30-12:15 New York (UTC-05)
Course code 14540

GBP 1,299 1,499
EUR 1,819 2,099
USD 2,087 2,399

Until 20 Jan

4 sessions of 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

View basket

Not ready to book yet?

for 7 days, no obligation

21-22 July 2025

Live online

09:30-17:15 UK (London) (UTC+01)
10:30-18:15 Paris (UTC+02)
04:30-12:15 New York (UTC-04)
Timings may be different for each day
Course code 14828

GBP 1,299 1,499
EUR 1,819 2,099
USD 2,087 2,399

Until 16 Jun

2 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

View basket

Not ready to book yet?

for 7 days, no obligation

10-11 November 2025

Live online

09:30-17:15 UK (London) (UTC+00)
10:30-18:15 Paris (UTC+01)
04:30-12:15 New York (UTC-05)
Timings may be different for each day
Course code 15056

GBP 1,299 1,499
EUR 1,819 2,099
USD 2,087 2,399

Until 06 Oct

2 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

View basket

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

The webinar was very informative and the speaker had very good knowledge of the topic covered.

Nov 11 2024

Lucy Barden United Kingdom
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 United Kingdom
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 United Kingdom
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 United Kingdom
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 United Kingdom
Quality Control Technician, Hyaltech Ltd

Nov 14 2022

Very interesting and useful.

Stephane Hauduc United Kingdom
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 Switzerland
Pharmaceutical Development Laboratory Analyst, Sintetica

Jul 12 2021

Very good.

Sylwia Andrzejewska Austria
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 United Kingdom
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 United Kingdom
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 United Kingdom
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 United Kingdom
Stability Coordinator, Perrigo

Jul 4 2018

Very good, informative, good pace.

Tim Liddy United Kingdom
QC Supervisor, Perrigo UK

Dec 5 2017

Well organised, good break structures, good amount of content.

Joanna Seiffert United Kingdom
Senior Principle Scientist, Trio Medicines

Dec 5 2017

Very well managed and presented course, thank you.

Jane Stevens United Kingdom
Stability Analyst, Torbay Pharmacy Manufacturing Unit

Dec 5 2017

Well run and presented course. Comprehensive material. Approachable speaker.

Lola Cascino United Kingdom
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 United Kingdom
Regulatory Affairs Team Leader (UK Team), RPH Pharmaceuticals AB

Jul 5 2017

Very comprehensive but digestible.

Matthew Lait United Kingdom
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 United Kingdom
R&D Scientist, TEVA

Dec 5 2017

Very good, well spaced breaks and good facilities. Good timings and content .

Ania Masters United Kingdom
Section head of stability, Bard Pharmaceuticals

Dec 5 2017

Excellent, content covered all expected aspects. Speaker was highly knowledgable.

James Murray United Kingdom
Medical Chemist, Mexichem UK Limited

Dec 5 2017

Covered all I needed.

Claire McGuinness United Kingdom
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 United Kingdom
Senior Principle Scientist, Trio Medicines

Jul 5 2017

Really good.

Thundiyil Pintoo Switzerland
R&D Analytical Laboratory Manager, Ginsana SA

Jul 5 2017

Very useful.

Jonathan Purdye United Kingdom
Chemistry Laboratory Manager, Torbay Pharmacy Manufacturing Unit

Dec 6 2016

Speakers were very helpful and experienced.

Lisa Cole United Kingdom
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 Switzerland
Product Development & Regulatory Affairs Manager, Dr. E. Graeub AG

Dec 6 2016

Useful course with applied knowledge information.

Gill French United Kingdom
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 United Kingdom
Senior Scientist , LGC

Jul 6 2016

It is a good course about stability.

Maria Jose Fernandez Spain
CHEMO Espana SL