How to Conduct Robust Root Cause Investigations for CAPA – Webcast On-Demand
In this 53-minute webcast, Danielle DeLucy, Subject Matter Expert in the areas of quality assurance and quality systems, shows how to effectively conduct robust root cause investigations for CAPA.
Your Webcast Content Package includes
- 53-minute webcast audio presentation
- 51-slide powerpoint presentation
- BONUS MATERIAL: Root Cause Analysis Report Form – This six (6) page PDF form includes 21 background and summary questions that will help you determine the root cause of your event.
Why Should You Attend
Conducting effective investigations is a Food and Drug Administration regulation, and one of the most cited 483 and Warning Letter citations. This webcast reviews the fundamentals of defining terms to a discussion of the best tools to use in conducting an investigation.
Areas Covered in the Webcast
Differences between correction, corrective action and preventive action, regulatory requirements for investigations and CAPA, what is a deviation? and identification of deviations is reviewed.
Minor, major and critical deviations are defined, and examples and case studies are included. Key elements of conducting the investigation, including scope and identification of the deviation, purpose, identifying other batches potentially affected, batch release considerations, interviews and documents are discussed.
What is a root cause analysis? Common principles of root cause analysis, general process for performing a root cause analysis, CAPA defined and elements of an effective CAPA process are reviewed.
The best tools to use for conducting a root cause analysis, including, flow charts, records, documents, interviews, five whys, cause and effect, fishbone and is/is not (Kepner Tregoe), diagramming and checklists is included.
Who Will Benefit
Industry professionals from many areas who may interact directly with regulatory inspectors or who help prepare for inspections, including:
- Quality Assurance/Quality Control
- Technical Operations
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Phone: (+1) 844.686.5750
Video Excerpts– See complimentary excerpts from the webcast
Getting to Root Cause During Your Investigation: A QC Lab Example
Correction, Corrective Action and Preventive Action Defined
Danielle DeLucy is an industry veteran and specializes in the areas of Quality Assurance and Quality Systems as a consultant. Prior to this role, Danielle has been in the industry for 15 years serving in numerous quality management roles, such as the Director of Product Quality with oversight of sterility assurance practices and numerous filling and packaging operations. Danielle began her career as a Quality Control pharmaceutical microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the quality management arena with increasing responsibility. She has helped to lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who: 1) are faced with warning letters and consent decrees; 2) wish to improve GxP practices; and 3) need to establish more robust quality systems.
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