Management Forum courses now available at IPI Academy - visit IPI for an updated experience and a broader selection of courses and subjects

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.

14-15 Nov 2022

& 6-9 Mar 2023 , 13-14 Jul 2023 , 13-14 Nov 2023

Book or reserve now

Details

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

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

Programme

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

Presenter

Paul Palmer (More...)

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.

Book now

Book or reserve now

NEW higher discounts for booking multiple places - 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

Choose your date below - or reserve your place with no obligation for 7 days at ipi.academy: Reserve now
14-15 Nov 2022
Live webinar
09:30-17:15
UK (London)
14-15 Nov 2022
Live webinar
09:30-17:15
UK (London)
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 10 Oct*
Enrol now
to attend Live webinar
6-9 Mar 2023
Live webinar
13:30-17:15
UK (London)
6-9 Mar 2023
Live webinar
13:30-17:15
UK (London)
GBP 1,299 1,099
EUR 1,869 1,589
USD 2,129 1,817
Until 30 Jan 23*
Enrol now
to attend Live webinar
13-14 Jul 2023
Face-to-face, Rembrandt Hotel London
09:00-17:15
UK (London)
13-14 Jul 2023
Face-to-face
Rembrandt Hotel London
09:00-17:15
UK (London)
GBP 1,499 1,299
EUR 2,149 1,869
USD 2,449 2,137
Until 8 Jun 23*
Enrol now
to attend Face-to-face
Rembrandt Hotel London
  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
13-14 Nov 2023
Live webinar
09:30-17:15
UK (London)
13-14 Nov 2023
Live webinar
09:30-17:15
UK (London)
GBP 1,299 1,099
EUR 1,869 1,589
USD 2,129 1,817
Until 9 Oct 23*
Enrol now
to attend Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

You may also be interested in

Previous customers include...

  • Torbay Pharmaceuticals
  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • Allergan Pharmaceuticals (Ireland)
  • AstraZeneca Operations
  • Benta SAL
  • Camurus AB
  • Cheplapharm Arzneimittel GmbH
  • Colonis Pharma
  • Dr. E. Graeub AG
  • ELPEN Pharmaceutical Co. Inc.
  • Fresenius Kabi Deutschland GmbH
  • Gebro Pharma GmbH
  • GlaxoSmithKline Vaccines
  • GW Pharma Ltd
  • LGC
  • LGC Ltd
  • MeiraGTx
  • Mexichem UK Limited
  • Mylan
  • Nicobrand Limited
  • orphan europe
  • Perrigo
  • Recipharm
  • RPH Pharmaceuticals AB
  • Sanofi
  • TEVA
  • Teva UK Ltd
  • Torbay Pharmaceuticals
  • Valneva Austria GmbH
  • Veterinary Medicines Directorate

The webinar was really informative and speakers were great. I would highly recommend this course.

Valeria Ciapessoni, Pharmaceutical Development Laboratory Analyst, Sintetica, Dec 21

Very good.

Sylwia Andrzejewska, Stability Coordinator CTM Analytics Austria, CTM Analytics, Valneva Austria GmbH, Jul 21

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, Dec 19

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 19

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 19

[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 18

Very good, informative, good pace.

Tim Liddy, QC Supervisor, Perrigo UK, Jul 18

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, Dec 17

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

Lola Cascino, QC Scientist, G-Pharm Ltd, Dec 17

Covered all I needed.

Claire McGuinness, Research Chemist, Mexichem UK Limited, Dec 17

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

James Murray, Medical Chemist, Mexichem UK Limited, Dec 17

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

Ania Masters, Section head of stability, Bard Pharmaceuticals, Dec 17

Very well managed and presented course, thank you.

Jane Stevens, Stability Analyst, Torbay Pharmacy Manufacturing Unit, Dec 17

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

Joanna Seiffert, Senior Principle Scientist, Trio Medicines, Dec 17

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, Jul 17