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This live training session will cover in detail the documentation requirements for OOS investigations, which is one of the main causes of Warning Letters. Discussion will include of how an investigation plan is designed, acceptance criteria are set and timelines and responsibilities are determined. This session will also introduce the content of an investigation report.
Learning Benefits
- Design a systematic investigation plan
- Determine root causes
- Components of an investigation report
- Timelines and responsibilities
- Establish Corrective Actions and Preventive Actions
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...
