Dublin, Oct. 27, 2023 (GLOBE NEWSWIRE) -- 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:
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Comply with stability requirements for new and existing drug substances, products and line extensions
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Gain knowledge on storage tests, conditions and protocols
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Learn how to design highly efficient protocols for global marketing with potentially large financial savings
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Discover how to manage stability samples and facilities
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Understand what stability testing is required following changes to a product
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Discuss data treatment, shelf-life assignment and extrapolation
Personnel involved in:
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Stability testing of pharmaceuticals and biopharmaceuticals
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The design of stability protocols
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The management of stability samples and facilities
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The development of pharmaceuticals which require stability testing
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The production of regulatory documents which include stability data
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Quality assurance
Key Topics Covered:
Background to stability testing and guidelines
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The rationale for stability testing
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Relevant guidelines
Storage tests, conditions and protocols
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Tests for drug substance and product types
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Storage conditions and periods required
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Typical protocols
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Developing global stability protocols
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In-use testing
Exercise 1: Designing a simple stability protocol
Management of stability samples and facilities
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Sample management
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Validation of storage facilities
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How to treat excursions from condition
Requirements for existing products, line extensions and variations
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Guidelines available (ICH, EU and USA)
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Requirements for active ingredient
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Requirements for product
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Requirements for variations to marketed products