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Analytical procedures are critical to ensuring drug products meet standards of identity, strength, quality, and purity throughout their shelf life. cGMPs require validated stability-indicating methods, and forced degradation studies are essential to demonstrate method specificity and stability-indicating capability.
This live webinar will review validation requirements per ICH Q2(R1) and FDA guidance, expectations for stability-indicating methods, and the role of forced degradation studies. The session will also cover the use of compendial methods in stability programs, along with verification and lifecycle considerations.
Learning Benefits
- Understand the role of analytical testing in drug development
- Establish key factors for stability-indicating methods
- Apply specificity requirements from ICH Q2A&B
- Design forced degradation studies for APIs and drug products
- Identify considerations for working with compendial methods
- Differentiate validation, verification, and transfer
Who Should Attend
- Quality Control
- Quality Assurance
- Analysts and Laboratory Managers
- Regulatory Affairs Professionals
- Pharmaceutical Scientists
- Compliance Scientists
- Manufacturers of raw materials and ingredients
Kim Huynh-Ba
Kim Huynh-Ba has over 30 years of experience in quality systems, analytical development, project management, strategic drug development, and stability sciences. She currently is the managing director and CEO of Pharmalytik. where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree. She also has provided support to build Quality Management Systems (QMS) for many clients in the US and abroad. From 2011-2013, she took a sabbatical from Pharmalytik to join the U.S. Pharmacopeia...
