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      Developing an Effective CAPA Management and Root Cause Analysis System in Bakersfield

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      June 21, 2019

      Friday  12:00 PM - 1:00 PM

      Bakersfield - ONLINE
      Bakersfield, California

      • No Performers Listed
      Developing an Effective CAPA Management and Root Cause Analysis System


      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.


      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
      Establishing a CAPA plan: project summary, individual responsibilities and expected completion dates
      Management and Oversight of the CAPA system and its documentation


      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.


      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


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


      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.

      DATE &TIME:

      Date: 2019-06-21
      Time: 12:00 PM PST | 03:00 PM EST

      Duration: 60 Minutes

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      Cost: Payment required -

      Categories: Other & Miscellaneous

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.