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When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
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.
Learn moreRemember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.
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 90-minute 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.
One Part of the FDA Inspection Readiness Certification
This training is one part of the 15-hour intensive series required for the FDA Inspection Readiness Professional Certification.
Attend this training as a step in the certification process or as a stand-alone course for personal career advancement and training.
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.
This training is part of a 10 course (15 hour) series required for the FDA Inspection Readiness Certification.
Click below to learn more about this Certification Program and/or Register for the Entire Program
Danielle DeLucy, MS
Owner, ASA Training & Quality Consulting LLC