14 Days Left
Out-of-Trend results are among the earliest warning signs that a drug product's quality profile is shifting, and catching them before they become Out-of-Specification failures is one of the most valuable things a pharmaceutical quality team can do. This live training session with Kim Huynh-Ba provides a practical examination of OOT analysis for both stable and changed drug product properties, walking attendees through how to establish meaningful trends, apply risk assessments to determine critical quality attributes and work effectively with cross-functional teams to continuously monitor and improve product performance.
Learning Benefits
- Recognize different types of OOT results
- Establish trend for release and stability data
- Understand risk assessments to determine Critical Quality Attribute (CQA)
- Determine course of actions to process
- Understand cross-functional investigations
- Monitoring product trends to avoid OOS
Who Should Attend
- Quality Assurance Personnel
- Quality Control Personnel
- Research and Development
- Regulatory Affairs Professionals
- Auditors
- Validation
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...
