Developing an Effective CAPA Management and Root Cause Analysis System

11:00 PM ET | 08:00 AM PT | 10:00 AM CT Duration 180 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 180 mins Live Webinar

"Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems"

Develop CAPAs pertaining to longer term projects

Description

In order to solve problems every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective 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.In order to solve problems every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective 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 You Should Attend:

This webinar will include discussions proper CAPA system maintenance, root cause analysis, documentation of the Corrective and Preventative Actions 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 CAPA is needed
     •    Development of the essential pieces of a robust CAPA plan
•     Root Cause Analysis Methods
     •     Discussion of different Root Cause Analysis methods and benefits of each
•     Establishment of the CAPA Plan
     •     Project Summary development
     •     Responsibilities of individuals involved
     •     Establishing Completion Dates
     •     Creating meaningful effectiveness checks
•     Management of the CAPA System
     •     Maintaining proper documentation of the CAPA plans
     •     Ensuring CAPA plans are progressing
     •     Proper close out of CAPA plans

Who will Benefit

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

Industries who can attend

This 180 -minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Danielle DeLucy

Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy 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.

Ms. DeLucy began her QA career as a quality control pharmaceutical microbiologist at Lancaster Laboratories, 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 lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, she assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.

Back to Top