Developing an Effective CAPA Management and Root Cause Analysis System
Learn when a CAPA is required, how to choose root cause analysis methods, build a CAPA plan with owners and dates, check effectiveness and manage CAPAs through closure.
Speaker
Danielle DeLucy
Pharmaceutical quality consultant · ASA Training and Consulting, LLC · MS
Overview
Every organization needs to investigate problems well, find root causes and put workable corrective action in place on time. This 60-minute CAPA and root cause analysis training shows how to build a system that does that.
An effective CAPA process depends on trained internal investigators who think critically and can coach others, and on a common model and language so investigators learn the process quickly. You'll cover what a CAPA is, when one is required, and the root cause analysis methods available and their benefits.
The session then covers building a CAPA plan, effectiveness checks, documentation, tracking progress and proper closure, including keeping longer-term CAPA projects on track.
Why attend: A weak CAPA system lets problems recur and leaves gaps in documentation. This webinar covers proper CAPA system maintenance, root cause analysis, CAPA documentation and building a robust CAPA plan, with tips for keeping long-term CAPAs on schedule. It suits quality control, quality assurance, manufacturing, regulatory affairs and supplier quality staff and managers, and senior management.
What’s covered
- What a CAPA is and when it is required
- What to do when problems occur
- Key pieces of a strong CAPA plan and building a CAPA file
- Root cause analysis methods and their benefits
- Establishing a CAPA plan: project summary, individual responsibilities and completion dates
- Creating meaningful effectiveness checks
- Managing the CAPA system
- Maintaining CAPA documentation
- Making sure CAPA plans progress
- Properly closing out CAPA plans
Who should attend
What you get
About the speaker
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. 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, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA 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 while increasing her 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 are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.
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