COURSE ID 3013

CAPA: Definition, Plan and Program

Part of the Cobblestone FDA Inspection Readiness Certification

AVAILABLE ON-DEMAND
Duration: 90 Minutes
Course Instructor

Danielle DeLucy, M.S.

Price
$ 295
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

View Course Outline

The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if you want an inspection that results in a satisfactory report.

To this end, this accredited course will include discussions of proper CAPA system maintenance, root cause analysis, 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.

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

  • Discuss what to do when problems occur
  • Outline the requirements of the CAPA process and procedure including building a CAPA file
  • Choose the most appropriate Root Cause Analysis methods for the situation
  • Establish a CAPA plan: project summary, individual responsibilities and expected completion dates
  • Manage and maintain oversight of the CAPA system and its documentation

This training is part of a 10 course (15 hour) series required for the FDA Inspection Readiness Certification. Attend this training as a step in the certification process or as a stand-alone course for personal career advancement and training.

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This course will be valuable to all individuals working within or managing a manufacturing program that supports either the R&D development of a new drug product or the manufacture of commercial drug product released to the market and would be beneficial to professionals in:

  • Quality Control
  • Quality Assurance
  • Technical Operations
  • Contract Manufacturers
  • Manufacturing and Filling Operations
  • Research & Development

Regulatory affairs personnel as well as individuals who are responsible for the review or audit of such inspections and reports would likewise find this course very worthwhile.

Course Instructor

Danielle DeLucy, M.S.

Owner, ASA Training & Quality Consulting LLC

Danielle DeLucy, M.S.’s Courses
Team Training

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Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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