106 Days Left
Design and Implement an Effective Stability Program to Support Marketed Products and Maintain Compliance to the Latest FDA, ICH and WHO Regulatory Requirements
Stability is a critical quality attribute of pharmaceutical products, and stability programs are essential not just for registration but also for supporting marketed products post-launch. Designing and implementing an effective program helps ensure product consistency, supports changes, and provides data for investigations while maintaining compliance.
This live webinar will outline key activities to sustain a stability program across the product lifecycle, review common compliance deficiencies, and explain how to align with the latest FDA, ICH, and WHO requirements.
Learning Benefits
- Understand the role of stability programs for marketed products
- Apply the latest FDA, ICH, and WHO requirements
- Develop standard stability protocols for consistency
- Build product knowledge to manage changes effectively
- Establish control strategies to support manufacturing and distribution
- Incorporate analytical procedures to maintain efficiencies
- Identify deficiencies and sustain global compliance
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...
