Four Day Stability Testing of Pharmaceuticals and Biopharmaceuticals Virtual Training Course

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Dec 15, 2023, 06:30 ET

DUBLIN, Dec. 15, 2023 /PRNewswire/ -- The "Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course" conference has been added to ResearchAndMarkets.com's offering.

This four-day seminar offers delegates an invaluable opportunity to enhance their expertise in the realm of stability studies.

Throughout the program, participants will gain essential insights into conducting appropriate stability studies, efficiently managing stability samples and facilities, and designing studies that align with global marketing requirements.

By acquiring the knowledge and skills presented in this seminar, attendees can significantly enhance the likelihood of regulatory approval for their studies, ultimately resulting in resource savings and substantial financial benefits.

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

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

Key Topics Covered:

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

Speakers:

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.

For more information about this conference visit https://www.researchandmarkets.com/r/h6yvcm

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