ALS Webinars: Stability Studies for Pharmaceutical and Personal Care Products

Join Ranil Fernando in this complimentary webinar to thoroughly understand the regulations and guidelines for conducting stability studies for Pharmaceutical, Over-the-Counter, and Personal Care formulations. This session aims to equip you with vital knowledge and practical insights essential for ensuring product safety and effectiveness.
Overview:
• Regulations & Guidance: Key regulations and guidance sources.
• Glossary: Frequently used terms and definitions.
• Study Types: Required studies for regulatory compliance.
• Development Stages: Stability studies for different formulation stages.
• Climate Zones: Considerations for formulation distribution.
• Tests: Necessary tests based on formulation type.
• Handling Failures: Managing stability failures and out-of-spec results.
• Example Scenarios: Various stability study designs.
• Method Validation: Requirements for active ingredients and photo-stability.
• Stability Protocols: Basics and product specification examples.
• Sample Requirements: Guidance on bracketing and matrix design.
• Data & Reporting: Suggestions and reference documents.