Dublin, Oct. 20, 2023 (GLOBE NEWSWIRE) -- The "Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course" conference has been added to ResearchAndMarkets.com's offering.
Prepare to enhance your expertise in the pharmaceutical industry with this intensive two-day seminar on stability studies and protocols. This comprehensive program is designed to equip participants with the knowledge and skills required to excel in stability testing, ensuring regulatory compliance and substantial cost savings.
Course Highlights:
- Master Stability Studies: Learn how to conduct rigorous stability studies, efficiently manage stability samples, and optimize your facilities to meet regulatory standards.
- Global Marketing Readiness: Design stability studies that are tailored for global marketing, increasing the likelihood of regulatory approval.
- Resource Efficiency: Discover strategies to save valuable resources on stability testing, resulting in significant financial savings.
- Biopharmaceutical Stability: This updated course now includes vital insights into the stability of biopharmaceuticals, making it even more valuable for industry professionals.
Throughout the program, practical exercises will empower participants to apply their newfound knowledge with guidance from our experienced trainers.
Benefits of Attending:
- Compliance Assurance: Ensure compliance with stability requirements for new and existing drug substances, products, and line extensions.
- Storage Expertise: Gain a deep understanding of storage tests, conditions, and protocols.
- Efficiency Mastery: Learn to design highly efficient stability protocols tailored for global marketing, potentially leading to substantial financial savings.
- Facility Management: Discover effective strategies for managing stability samples and facilities.
- Change Adaptation: Understand the stability testing required when making changes to a product.
- Data Handling: Engage in discussions on data treatment, shelf-life assignment, and extrapolation.
Certification:
- CPD Accreditation: Earn 12 CPD hours for your professional development records.
- Certificate of Completion: Upon successfully completing the seminar, receive a certificate recognizing your achievement.
Who Should Attend:
This seminar is ideal for individuals involved in:
- Stability testing of pharmaceuticals and biopharmaceuticals
- The design of stability protocols
- The management of stability samples and facilities
- The development of pharmaceuticals requiring stability testing
- The creation of regulatory documents incorporating stability data
- Quality assurance professionals seeking to bolster their expertise
Agenda:
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 the condition
Requirements for existing products, line extensions, and variations
- Guidelines available (ICH, EU, and USA)
- Requirements for the 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
For more information about this conference visit https://www.researchandmarkets.com/r/xol5l1
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