Investigating and Reporting Biopharmaceutical Nonconformances

Onsite Training & Consulting
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Course Description

Improper investigation of mix-ups and errors leads to increased regulatory scrutiny and enforcement actions by the FDA. In 2010 improper failure investigations were cited in over 30% of the FDA 483 observations.

This course provides an understanding of the origin of nonconformances, including human and system errors, and a framework for the implementation of follow-up actions, including effective root cause analysis and CAPA to mitigate future problems. This program includes discussions and workshops focused on ensuring complete understanding of CAPA regulatory requirements as they relate to biopharmaceuticals. Participants will learn how to create a system for investigating and reporting deviations and other nonconformances as part of an effective quality management system.



CEUs:1.5
Number of days:2
Code:NCP
Cost:$1495.00

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Objectives
  • Understand the costs of failures and nonconformances.
  • Initiate an investigative process following a nonconforming event.
  • Implement an immediate corrective action to remedy a nonconformance.
  • Identify the characteristics of a well-written nonconformance event report.
  • Learn how to comprehensively document a deviation or a discrepancy.
  • Define unplanned and planned nonconformances.
  • Utilize the root cause analysis tools to determine root causes of failures.
  • Identify and interpret the CGMP requirements and expectations of a pharmaceutical CAPA system.
  • Recognize the benefits of an effective CAPA system.
  • Describe process flow in a CAPA system.
  • Identify practical aspects of managing the CAPA system during FDA inspections.
Topics
  • FDA drugs and biologics regulations as they relate to investigations
  • Causes of mix-ups and errors: human and system
  • Root cause analysis approach and tools
  • Applying CAPA principles
  • Establishment of an effective CAPA system
  • FDA inspectional observations and analysis
Who Should Attend

This course is recommended for biopharmaceutical professionals, technicians, and general staff in quality assurance, quality control, manufacturing, metrology, or maintenance.

 

Upcoming dates and locations
Please contact us if you need additional information or if you don't see a date that works for you.
To register by phone, call 800.472.6477

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Course Name On-Site Public Dates
Location Start Date Days Cost Registration
Investigating and Reporting Biopharmaceutical Nonconformances CONTACT US San Juan, PR 06/25/2012 2 $1495.00 Add to Cart
Investigating and Reporting Biopharmaceutical Nonconformances CONTACT US Chicago, IL 07/30/2012 2 $1495.00 Add to Cart
Investigating and Reporting Biopharmaceutical Nonconformances CONTACT US Princeton, NJ 08/20/2012 2 $1495.00 Add to Cart
Investigating and Reporting Biopharmaceutical Nonconformances CONTACT US San Francisco, CA 09/10/2012 2 $1495.00 Add to Cart
 
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