CAPA and Root Cause Analysis: Developing, Documenting and Managing a Robust System

    /Danielle  /DeLucyspeaker of Training Doyensinvite
    Speaker: Danielle DeLucy


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    Duration: 60 Minutes
    Product Code: 50935
    Level: Intermediate
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OVERVIEW

In order to solve problems every organization must know how to conduct an effective event investigation, identify root causes, and implement workable corrective action in a timely manner. An effective Corrective Action and Preventative Action (CAPA) process requires training internal investigators, who can also coach others in the organization, to employ critical thinking.

The process must provide a common model and language within the organization, which allows investigators to master the process quickly and easily.

WHY SHOULD YOU ATTEND

This webinar will include discussions on proper CAPA system maintenance, root cause analysis, documentation of CAPA and developing a robust CAPA plan. It will give tips on how to develop CAPAs pertaining to longer term projects and ensure they stay on track.

AREAS COVERED

Definition of a CAPA

  • When a corrective action and preventative action (CAPA) is needed
  • Development of the essential pieces of a robust CAPA plan

Root Cause Analysis Methods

  • Discussion of different Root Cause Analysis (RCA), methods and benefits of each

Establishment of the CAPA Plan

  • Project summary development
  • Responsibilities of individuals involved
  • Establishing completion dates
  • Creating meaningful effectiveness checks

CAPA Management

  • Maintaining proper documentation of CAPA plans
  • Ensuring CAPA plans are progressing
  • Proper close out of CAPA plans

LEARNING OBJECTIVES

Learn the fundamentals of corrective action and preventative action (CAPA) and root cause analysis (RCA). Also learn the techniques of CAPA plan development, CAPA management and documentation of CAPA.

WHO WILL BENEFIT

  • Quality Control Personnel & Management
  • Manufacturing Personnel & Management
  • Senior Management
  • Regulatory Affairs Personnel & Management
  • Quality Assurance Personnel & Management
  • Supplier Quality Personnel & Management

SPEAKER

Years of Experience: 19+ years

Areas of Expertise: Quality Management in Pharmaceuticals

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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