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Conducting a Robust Root Cause Investigations for CAPA

  November 06, 2019  
CfPA-The Center for Professional Advancement, Edison, NJ or Virtually
March 26-27, 2020

Who Should Attend?
This is an informative and interactive seminar for professionals in the pharmaceutical, biological, and medical device industries who conduct deviations, Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) investigations, especially for professionals in the following disciplines:
  • Quality Control Analysts
  • R&D
  • Quality Assurance
  • Manufacturing
  • Product/Process Development
  • Engineering

Members of the management team who oversee or interact with those performing deviation investigations would additionally benefit from this course with a broader understanding of the process.

Course Description
One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA uses the investigation reports and investigation trends to identify potential quality problems in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, release of sub-standard product, or product recall. Furthermore, costly and time-consuming system remediation may be required.

Having a procedure on Deviation Investigations is not enough. It is the content and conclusions of the investigations themselves that truly count. Doing a proper root cause analysis, gathering evidence and ensuring a sustainable corrective action is key to a proper deviation investigation.

This seminar will help attendees understand the fundamental investigation steps and skill sets. Key focus will be placed on identification and initial reporting of deviations, fact/evidence gathering, and arriving at the correct root cause and CAPA. The importance of investigation planning, critical thinking skills and effective preventative action plans will also be discussed.

Root Cause Analysis (RCA) is an important technique practiced by many successful companies. It is used to determine the Corrective Action and Preventive Action CAPA procedures that are mandatory for the Quality Management Systems (QMS). This training improves the way you analyze, document, and verify the root causes of a problem so that you can prevent their recurrence.

This course will also include discussions on proper CAPA system maintenance, 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.


Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
   Kimberly Johnson, M.S. RA/QA, CQA, Consultant to the Pharmaceutical Industry

Kimberly Johnson, is an industry veteran and specializes in the areas of Quality Assurance and Quality Management Systems. Prior to consulting, Ms. Johnson has been in the industry 25+ years serving in numerous quality management roles with start ups to Fortune 500 companies (DepoTech, Bristol Myers Squibb, Wyeth, Purdue Pharma, Watson Laboratories, Inc., Pii and Cambrex) managing combination products, medical devices, parenterals and pharmaceuticals (solid and liquid oral, topical and transdermal).

Ms. Johnson is skilled in the development, implementation, maintenance and continuous improvement of Quality Management Systems that include Audits & Inspections, Document Management, Change Management, Risk Management, Corrective and Preventive Action and Effectiveness programs, Deviations and Investigations, Complaint and MDR Handling, Supplier Qualification, Data Integrity and Quality System Management Metrics and Trending.
Deadline for Abstracts: N/A
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
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