Developing an Effective CAPA Management and Root Cause Analysis System

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Hear By 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"

Effective CAPA process requires training internal investigators

Description

This 90-minute webinar will include discussions on 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.

Objectives

•          Analyze what steps to take when there is an issue
•          Know what are the requirements of the CAPA process and procedures and how to build a CAPA file
•          Find an appropriate Root Cause Analysis methods for the scenario
•          How to establish a CAPA plan – expected deadlines, project summary and individual responsibilities
•          Oversight and management of the CAPA system and its documentation

Why Should You Attend

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.

Areas Covered

•          CAPA Definition
             •       When is a CAPA required
             •       Developing crucial pieces of a strong CAPA plan
•          Root Cause Analysis Methods
             •       Discussing various Root Cause Analysis methods and their benefits
•          Establishment a CAPA Plan
             •       Project Summary development
             •       Individual responsibilities involved
             •       Finalizing Completion Dates
             •       Creating meaningful effectiveness checks
•          Managing the CAPA System
             •       Maintaining proper documentation of the CAPA plans
             •       Ensuring CAPA plans are progressing
             •       Proper close out of CAPA plans

Who will Benefit

This training is intended for professionals in the Pharmaceutical and other related life science industries. It will be especially valuable for the following:
•          Quality Control Personnel & Management
•          Manufacturing Personnel & Management
•          Senior Management
•          Regulatory Affairs Personnel & Management
•          Quality Assurance Personnel & Management
•          Supplier Quality Personnel & Management
•          Product/Process Development Staff

Industries who can attend

This 90-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.

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