Stability Testing of Pharmaceuticals

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learning how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

3-4 Jul 2019

& 4-5 Dec 2019 , 7-8 Jul 2020 , 2-3 Dec 2020

GBP 1,499
EUR 2,099
USD 2,338

Book now

Course overview

By attending this comprehensive two- day seminar, delegates will:

  • Learn how to design efficient stability studies that are suitable for global marketing
  • Be able to carry out appropriate stability studies and manage stability samples and facilities
  • Know how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols

Please note that this course will not cover particulars of the stability of biopharmaceuticals.

Benefits of attending:

  • Comply with stability requirements for new and existing drug substance products and line extensions
  • Gain knowledge on storage tests, conditions and protocols
  • Learn how to design highly efficient protocols for global marketing
  • Discover how to manage stability samples and facilities
  • Develop robust stability indicating methods
  • 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 pharmaceutical products
  • 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 day one

Delegate introductions
Background to stability testing and guidelines

  • The rationale for stability testing
  • Relevant guidelines Refreshments

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 one

  • 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 two

  • Designing a more complex stability protocol

Developing robust, stability indicating methods

  • Producing impurities
  • Guidance on stress testing
  • Producing potential impurities of degradation
  • Choosing columns and mobile phases
  • Ensuring the method is robust

Light stability testing

  • ICH Q1B guidelines
  • Light sources
  • Required exposure
  • Problems in light testing

Programme day two

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 three

  • Data treatment

Packaging considerations

  • Guidelines
  • Requirements when changing packaging
  • Demonstrating equivalence
  • Permeation considerations
  • Interaction studies

Exercise four

  • Packaging

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 five

  • Designing efficient stability protocols

Exercise five (continued)

Presenter

Ray Munden (3-4 Jul 2019, 4-5 Dec 2019)

Dr Raymond Munden has over 30 years’ experience in pharmaceutical research and development and was formerly Head, Analytical Services Europe for GlaxoSmithKline. He has led project teams that developed many new chemical entities and their pharmaceutical products that were successfully taken to market. Dr Munden has particular expertise in stability protocol design and testing, stability storage facilities, experimental design and degradation chemistry. He is now a consultant for all aspects of pharmaceutical development.

Book now

3-4 Jul 2019
3-4 Jul 2019 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
4-5 Dec 2019
4-5 Dec 2019 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
7-8 Jul 2020
7-8 Jul 2020 Venue not yet confirmed
+ VAT @ 20.00%
Enrol now
2-3 Dec 2020
2-3 Dec 2020 Venue not yet confirmed
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • 3X Consultants
  • Actavis Biologics Ltd
  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • ALK-Abelló A/S
  • Allergan Pharmaceuticals (Ireland)
  • Astrazeneca
  • Bard Pharmaceuticals Ltd
  • Bio Products Laboratory Limited
  • CHEMO Espana SL
  • Colonis Pharma
  • ConvaTec UK Ltd
  • Dr. E. Graeub AG
  • ELPEN Pharmaceutical Co. Inc.
  • Gebro Pharma GmbH
  • GlaxoSmithKline Vaccines
  • GW Pharma Ltd
  • LEK Pharmaceuticals d.d.
  • Mexichem UK Limited
  • Mylan
  • Novo Nordisk A/S
  • Perrigo
  • QPharma
  • Sanofi
  • Seven Seas Ltd
  • Special Products Ltd
  • TEVA
  • Torbay Pharmacy Manufacturing Unit
  • Vericore Limited
  • Veterinary Medicines Directorate
  • Zoetis Belgium SA

Very good, informative, good pace.

Tim Liddy, QC Supervisor, Perrigo UK

[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

Covered all I needed

Claire McGuinness, Research Chemist, Mexichem UK Limited

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

Ania Masters, Section head of stability, Bard Pharmaceuticals

Well organised, good break structures, good amount of content

Joanna Seiffert, Senior Principle Scientist, Trio Medicines

Very well managed and presented course, thank you

Jane Stevens, Stability Analyst, Torbay Pharmacy Manufacturing Unit

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

James Murray, Medical Chemist, Mexichem UK Limited

Well run and presented course. Comprehensive material. Approachable speaker

Lola Cascino, QC Scientist, G-Pharm Ltd

Very knowledgeable and patient speaker, useful practical workshops, found content covered what I needed and introduced all relevant guidelines that I needed

Joanna Seiffert, Senior Principle Scientist, Trio Medicines

Really good

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

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

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

Very useful

Jonathan Purdye, Chemistry Laboratory Manager, Torbay Pharmacy Manufacturing Unit

Very comprehensive but digestible.

Matthew Lait, Regulatory Affairs Officer, RPH Pharmaceuticals AB

Ray is an expert in the field and his knowledge, enthusiasm an willingness to answer questions and target as we go have made the training interactive and enjoyable. Sometimes the pace of going through the slides felt a bit high. I do appreciate the time is limited.

Blagovesta Tomova, Senior Scientist , LGC

Speakers were very helpful and experienced

Lisa Cole, Senior Medical Information Officer, Fresenius Kabi

Useful course with applied knowledge information

Gill French, , Astrazeneca

Great content, well delivered.

Mark Bell, , Bard Pharmaceuticals

The training was well organized. 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

It is a good course about stability

Maria Jose Fernandez, , CHEMO Espana SL

Enjoyable, good content. Able to answer all my questions.

Mark Bell, , Bard Pharmaceuticals