Dublin, Feb. 06, 2025 (GLOBE NEWSWIRE) -- The "Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course" has been added to ResearchAndMarkets.com's offering.

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

Certifications:

• CPD: 12 hours for your records
• Certificate of completion

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

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

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

For more information about this conference visit https://www.researchandmarkets.com/r/5amdw8

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