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The stability program is critical for product registration and maintaining quality through expiry. Any change to the product, process, or package requires additional stability studies. GMP regulations mandate a robust change control system to monitor these changes and mitigate risks.
This webinar will explore types of changes across the drug product lifecycle, how they affect product stability, and the risks involved. Attendees will gain insights into establishing compliant change control systems and managing risks to maintain stability throughout a product’s shelf life.
Learning Benefits
- Define stability as a critical quality attribute
- Identify CMC changes during the product lifecycle
- Understand how changes affect product stability through expiry
- Differentiate between minor and major stability program changes
- Assess potential risks and how to manage them
Who Should Attend
- Quality Control
- Quality Assurance
- Regulatory Affairs Professionals
- Raw Material & Ingredient Manufacturers
- Pharmaceutical & Compliance Scientists
- Analysts and Laboratory Managers
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...
