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
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 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
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14-15 Nov 2022 Live webinar 09:30-17:15 UK (London) |
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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* |
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to attend Live webinar |
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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.