Introduction to CAPA Management

A Critical Quality System Requirement

Duration: 60 Minutes
Course Instructor

Laura Jeannel

$ 195
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

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There have been several form 483s and warning letters being issued to companies by the FDA as it relates to CAPA investigation because of insufficient or incomplete quality systems procedures applicable to Corrective Action and Preventative Action programs (CAPA).

Addressing an FDA form 483 with findings associated with CAPA systems must be performed adequately, complete and must provide enough details within the CAPA procedures to ensure an effective CAPA investigational procedure.

All failure, deviation or out of specification investigations must be adequately documented, corrected, prevented, and checked for corrective action effectiveness through the use of a compliant CAPA investigational system and program. The result of a product investigation impacts the quality of the cGMP manufactured product label claim, to avoid it from being termed ‘adulterated” by the FDA which may result in product recalls, complaint, and further actions by the FDA.

In this introductory training, we will discuss and highlight to GMP professionals the importance of writing effective CAPAs from initiation, implementation, closure, effectiveness and follow-up. It will be a great resource for professionals to build and strengthen their CAPA Management program into a proactive and preventive system for Quality Management Systems. Additionally, key case examples will aid personnel in identifying the most effective means to continuously develop effective CAPAs for an enhanced and more robust program.

Upon completion of this course, you will be able to:

  • Initiate, complete, and perform effective writing skills for CAPA Management
  • Define key differences between Corrective Actions and Preventive Actions
  • Identify key implementation in a targeted manner in a multi-tasking environment
  • Show closing complete and robust CAPAs to prevent recurrence
  • Define CAPA Effectiveness
  • Evaluate Trend Management while building a proactive and preventive system as a key component to the Quality Management System
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This entry level training will provide a great resource to Medical Device, Pharmaceutical, and Biologics Industries personnel within the following departments:

  • Quality Assurance
  • Quality Control
  • Manufacturing
  • Facilities
  • Validation

Course Instructor

Laura Jeannel

Senior Quality Consultant, Farbridge Pharma Consulting

Laura Jeannel’s Courses


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