The "Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course" training has been added to ResearchAndMarkets.com's offering.
By attending this intensive two-day seminar, delegates will learn how to conduct effective stability studies, manage stability samples and facilities, and design studies suitable for global marketing. The seminar also aims to enhance regulatory approval success rates and help attendees optimize resources, leading to potential significant cost savings in stability testing.
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:
- 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
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
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
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 training visit https://www.researchandmarkets.com/r/prtkwk
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