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How to Conduct Robust Root Cause Investigations for CAPA

  December 10, 2018  
CfPA-The Center for Professional Advancement, New Brunswick, NJ or Virtually
February 27-28, 2019

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

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:
   Louis Angelucci; Consultant to the Pharmaceutical Industry

Louis Angelucci is a pharmaceutical professional with over 20 years’ experience in Quality Assurance, Quality Control, Regulatory Affairs, Validation, consent decree remediation as well as cGMP Compliance in the Medical Device and Pharmaceutical industries. He has worked for several well-known companies including Johnson & Johnson, Bristol-Meyer Squibb, Pfizer, Schering Plough and Merck. His experience has been either as a direct employee or as a contracting consultant while employed at Foster Wheeler and Aker Kvaerner. As a consultant Mr. Angelucci has worked at various project locations domestically and in Europe and Asia.

Mr. Angelucci is a degreed engineer with two master’s degrees in engineering, holds industry certifications with ASQ as a CQE, CQA and CPGP. He is currently the ASQ Philadelphia chapter Education Chair. In addition, he holds a PMP certification through the Project Management Institute. He has published numerous articles on the subjects of Validation and compliance and has been a speaker to industry groups such as ISPE, IVT, DIA, PDA and ASQ.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
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