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

Join us for a webinar on September 15 for a discussion of the webinar

This 90-minute accredited course will include discussions addressing 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.

Learning objectives

Upon completion of this training, you will be able to:

  • Discuss what to do when problems occur
  • Outline the requirements of the CAPA process and procedure including building a CAPA file
  • Choose the most appropriate Root Cause Analysis methods for the situation
  • Establish a CAPA plan: project summary, individual responsibilities and expected completion dates
  • Manage and maintain oversight of the CAPA system and its documentation

Review of Learning Objectives

Module 1:

Definition of a CAPA

  • When a CAPA is needed
  • Development of the essential pieces of a robust CAPA plan
  • Assigning a CAPA team and principal investigator

Root Cause Analysis Methods

  • Discussion of different Root Cause Analysis methods and benefits of each
  • How to differentiate between potential and probable root causes
  • What if a root cause cannot be identified

Module 2:

Establishment of the CAPA Plan

  • Project Summary development
  • Responsibilities of individuals involved
  • Establishing Completion Dates
  • Creating follow-up plans
  • Creating meaningful effectiveness checks

Module 3:

Management of the CAPA System

  • Maintaining proper documentation of the CAPA plans
  • Ensuring CAPA plans are progressing
  • Proper close out of CAPA plans
  • How to effectively use CAPAs for critical issues

Question and Answer Session

Who Should Attend?

This training is intended for professionals in the Pharmaceutical, Medical Device, Cosmetic 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

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

Faculty Danielle DeLucy

Faculty Danielle DeLucy

Danielle DeLucy, MS, is currently the owner of ASA Training & Quality Consulting, LLC, an Independent Consultant Agency 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 18 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 a contract laboratory where she performed various tests for their clients.

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