COURSE ID 3016

Best Practices for Investigation Deviations and Non-Conformances

Part of the Cobblestone FDA Inspection Readiness Professional Certification

AVAILABLE ON-DEMAND
Duration: 90 Minutes
Course Instructor

Danielle DeLucy, M.S.

Price
$ 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

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.

One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA uses the investigation reports and investigation trends to identify potential quality problems in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, release of sub-standard product, or product recall.

Furthermore, costly and time-consuming system remediation may be required. Having a procedure on deviation investigations is not enough. It is the content and conclusions of the investigations themselves that truly count. Doing a proper root cause analysis, gathering evidence and ensuring a sustainable corrective action is key to a proper deviation investigation.

This accredited course will help attendees understand the fundamental investigation steps and skill sets. Key focus will be placed on identification and initial reporting of deviations, fact/evidence gathering, and arriving at the correct root cause and CAPA. The importance of investigation planning, critical thinking skills and effective preventative action plans will also be discussed.

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

  • Discuss what to do when problems occur
  • Outline the requirements of the deviation and procedure including the deviation report
  • Choose the most appropriate root cause analysis methods for the situation
  • Discuss how to conduct the deviation and the tools to be used in the process
  • Review and discuss an example deviation using the tools suggested

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.

It will be beneficial to professionals in:

  • Quality Control
  • Quality Assurance
  • Technical Operation
  • 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

DeLucy_Danielle

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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