COURSE ID 3019

Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations

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.

When there is a need to make some change to an environment and/or resolve a problem, we must think about a project that could implement the necessary change and address the problem. But we can. It just run our project without proper justification. Justifying the project is a great mechanism to confirm that our project really addresses the need and paves the way for improvement. It helps us assure interested parties or stakeholders that the project implements a particular solution to the problem and explains why this solution is best, as compared to other alternative solutions.

This accredited course will help you understand and develop appropriate justification for implementing changes.

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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