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Failure Analysis Basics for CAPA Systems

  January 28, 2019  
CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
1-2 July 2019

Who Should Attend?
This 2-day course is intended for professionals from U.S. and international companies in the pharmaceutical, biologic, medical device and combination product industries and personnel who want to understand, manage, and utilize basic CAPA system concepts. The professionals who will benefit most from attending this course include:
  • Senior management
  • Regulatory Affairs, Regulatory Compliance, Quality Assurance, and Quality Control personnel
  • Quality, Manufacturing, and Design engineers
  • Sales and Marketing, Maintenance, and Operational personnel
  • Anyone else who manages, assesses, or performs any pharmaceutical,  biologic, medical device and combination product quality work

Course Description
This 2-day accredited training will help you understand the basics of U.S. and international pharmaceutical, biologic, medical device, and combination product corrective actions and preventive actions (CAPAs) You will also learn the purpose and scope of CAPAs, failure investigations and root cause analysis and risk management tools, when to initiate and not to initiate CAPAs, best CAPA practices, linkages between the CAPA system and other quality subsystems, the similarities and differences between FDA and Notified Body CAPA requirements.

Not only will there be a lecture and discussion, but also case studies, problem-solving workshops, and hands-on work using the computer in order to determine a) whether to initiate a CAPA, b) how to complete a CAPA, and c) how to use risk analyses tools when performing post-market assessment activities pertaining to source CAPA data.
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
   George Calafactor, Former FDA Investigator, Regulatory Compliance Consultant

George Calafactor is a 33-year food, cosmetic, drug, biologic, clinical, and medical device non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator and over 10 years of industrial experience as a biologic, pharmaceutical, and medical device industry quality assurance consultant, regulatory compliance specialist, and ASQ certified quality biomedical auditor. 

Mr. Calafactor’s educational background includes 2 BS degrees in Chemistry and Metallurgical Engineering from the University of Notre Dame, an MBA in International Business from Indiana University, and a MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices with a concentration in Regulatory Compliance from Northeastern University.

Mr. Calafactor not only has inspected, investigated, and audited all types of US and foreign food, cosmetic, drug, biologic, medical device, and clinical facilities, but has also performed various pharmaceutical and medical device quality assurance and regulatory compliance operations, such as monitoring and maintaining product and quality system failure investigations, non-conformances, complaints/ MDRs, and CAPAs, reconciling and analyzing numerous quality system data, writing and revising numerous top and mid-level written procedures, training various governmental and industry personnel in the areas of medical device quality, quality system, design control, and documentation and change control, and informing management and staff of current FDA and EU enforcement policies.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
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