Enhancing Stability Programs through Validated Stability Indicating Method

Description:

Analytical procedures are essential tools to assure that the drug product meets applicable standards of identity, strength, quality and purity during its shelf life. cGMPs require stability indicating methods to monitor the drug product’s stability profiles. Therefore, forced degradation studies are important to establish the stability indicating power of methods used for stability program.

This live session will discuss validation requirements according to ICH Q2 R1 and FDA guidance on analytical method validation, expectations for stability indicating methods and the forced degradation studies to address method specificity. We will also discuss compendial methods used in the stability program and method verification.

Learning Benefits:

• The impact of analytical testing in the drug development process.
• Establishing key factors for stability indicating methods.
• Understanding specificity requirement based on Q2 A&B.
• Designing forced degradation studies for API and drug products.
• Key considerations working with compendial methods.
• Understanding the relationship among validation, verification and transfer.

Webinar outline:

• Background of analytical testing to support drug development process,
• Discuss regulatory expectations through warning letters,
• Lifecycle approach for method validation
• Establish key factors for stability indicating methods,
• Understand specificity requirements based on Q2A&B,
• Forced degradation studies to challenge validation,
• Working with compendial methods and method verification,
• Understanding lifecycle method validation,
• Live Questions & Discussion

Who should attend:

The following individuals or disciplines will benefit from attending this Webinar:

• Quality Assurance personnel
• Quality Control personnel
• Analysts and Laboratory Managers
• Regulatory Affairs Professionals
• Pharmaceutical Scientists
• Compliance Scientists
• Manufacturers of raw material and ingredients