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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 (30)"

11-12 July 2024
+ 11-12 November 2024 »

from £1099

Need help?  Enrol or reserve

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.

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

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.

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 or 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

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

Enrol or reserve

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

Farah Nadeem
Paul R. Palmer Limited

Farah Nadeem is an Operations Manager at Paul R. Palmer Limited/ Pharmaceutical Consultant and a Trainee Qualified Person. Farah is a Pharmacist and recognised QA expert and has over 20 years of experience in the Pharmaceutical industry in the development, manufacture and supply of medicinal products.

Throughout her career, she has held various quality assurance roles and actively pursued new opportunities to expand her knowledge and expertise. As a result, she has gained a comprehensive understanding of manufacturing, storage, and distribution processes, as well as the facilities and services that support them. Involved in documentation management: writes, reviews, and audits SOPs and QMS implementations. Assists companies in meeting regulatory requirements.

In her current role as a QA Operations Manager for a Pharmaceutical Consultant Company, Farah Nadeem provides various solutions, including assistance in obtaining the first MIA(IMP) and MIA licenses, as well as preparation and hosting for regulatory inspections. Her work involves collaborating with Paul Palmer to offer services such as QP declarations for API manufacturers, regulatory inspection hosting, commercial and clinical batch release, compliance audits, and coaching and training in GxP.

More details

Farah Nadeem
Paul R. Palmer Limited

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

11-12 July 2024

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)
Course code 13808

  • GBP 1,299
  • EUR 1,869
  • USD 2,129

View basket 

 
Not ready to book yet?

for 7 days, no obligation

11-12 November 2024

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)
Course code 14037

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 07 Oct

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 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.

Nov 13 2023

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
  • Colonis Pharma
  • 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
  • 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
  • QPharma
  • Recipharm

Switzerland

  • Amal Therapeutics
  • Ares Trading S.A - affilitate of Merck Serono SA
  • Dr. E. Graeub AG
  • Ginsana SA
  • Sintetica

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

Austria

  • Gebro Pharma GmbH
  • Valneva Austria GmbH

Germany

  • Cheplapharm Arzneimittel GmbH
  • Fresenius Kabi Deutschland GmbH

Lebanon

  • Benta S.A.L
  • Benta SAL

Netherlands

  • Basic Pharma Manufacturing B.V.
  • Curium Netherlands B.V.

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.

Greece

  • Elpen Pharmaceutical Co Inc

Hungary

  • XELLIA Gyógyszervegyészeti Korlátolt Felelősségű Társaság

Ireland

  • Allergan Pharmaceuticals (Ireland)

Israel

  • Syqe Medical

Italy

  • Zambon SpA

Korea, Republic Of

  • Samsung Bioepis

Poland

  • Polpharma Biologics

Saudi Arabia

  • Saudi Food and Drug Authority

Singapore

  • GSK

Slovenia

  • LEK Pharmaceuticals d.d.

Enrol or reserve

Run Stability Testing of Pharmaceuticals and Biopharmaceuticals Live online for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • 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:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy