The Center for Professional Innovation & Education, Dublin, Ireland
November 11 - 13, 2009
Who Should Attend
Because of its comprehensive content, this course will prove most valuable to personnel in research and development, manufacturing, quality assurance, and quality control laboratory, who are involved in conducting and reporting failure investigations and deviations.
This includes but not limited to directors, managers, supervisors, team leaders, and scientists from a GMP environment, needing in depth knowledge on conducting and reporting failure investigations and process deviations.
Providing a step-by-step foundation for conducting failure investigations, this training course highlights FDA requirements and quality assurance overviews on how to document the results from your failure investigation. Inadequate failure investigations continue to be a major GMP deficiency cited during routine and for-cause U.S. Food and Drug Administration (FDA) inspections. The FDA recognizes that failures are a part of business but also expects comprehensive investigations, the application of scientific judgment, and learning from the experience and permanent solutions to the problems identified.
This course provides clarification on the scope of relevant guidance and the essential skills necessary to ensure compliant documentation. Attendees will examine each step of an effective investigation and learn what documentation is required along the way, perform Root Cause Analysis and explore FDA expectations regarding CAPA. Additionally, participants will learn to avoid common obstacles to success and practice conflict resolution skills. This three-day workshop outlines tips and techniques to improve failure investigations and identifies proposed corrective action which ensures successful implementation and closeout.
This continually updated course covers appropriate reporting of failure investigations and process deviations to satisfy FDA regulatory requirements. Among the topics to be discussed include:
- Discussion on FDA expectations regarding failures and process deviations
- Exploring deviation or incident reports, nonconforming material reports; NCR (nonconformance report)
- Out-of-Specification (OOS) results and validation failures
- Examining roles, responsibilities and guidelines for documenting the investigation
- Analyzing challenges and solutions for improving the review and approval process
- Examining best practice elements of technical writing
- Examining how each component fits within the CAPA system
- Performing Root Cause Analysis using best practice, step-by-step tools
- Documenting fact-based conclusion and proposed corrective actions
- Recommending and implementing Corrective Actions
- Auditing the failure or process deviation investigation to ensure follow-through and completion, Anticipating and avoiding common barriers and obstacles