Good Manufacturing Practices (GMP): FDA Citations and Warning Letters – Lessons Learned
The United States Food and Drug Administration (USFDA) conducts inspections of pharmaceutical manufacturing facilities worldwide to ensure compliance with current Good Manufacturing Practice (cGMP) standards. These inspections cover facilities that produce both active ingredients and finished products. Failure to comply with cGMP regulations renders any drugs manufactured by a company “adulterated” under the law, indicating they were not produced in accordance with cGMP conditions.
Access the “Good Manufacturing Practices (GMP): FDA Citations and Warning Letters — Lessons Learned” course here.
In recent years, the FDA has escalated enforcement actions, issuing warning letters, import alerts, and seizures to manufacturers found violating cGMP regulations. This course focuses on analyzing specific Warning Letters issued by the USFDA as case studies, examining non-compliance with 21 CFR 210 and 21 CFR 211 inspection systems.
The Good Manufacturing Practice (cGMP) refresher course elaborates on the fundamental and current requirements of global GMP guidelines. It delves into the essential prerequisites for all GMP-regulated activities subject to FDA inspection, analyzing recent trends from FDA inspection reports and enforcement actions.
Additionally, the course provides insights into how GMP personnel can monitor industry practices to stay up to date with FDA requirements. By extracting lessons from various warning letters, the course guides participants in developing a robust compliance regimen tailored to address repetitive GMP errors effectively.
Upon completion of this online course, trainees will:
- be able to understand the fundamental compliance requirements for current Good Manufacturing Practices (cGMP).
- be able to understand the Good Manufacturing Practices (GMP) global legal framework.
- be able to understand the recent updates in current Good Manufacturing Practice (cGMP) regulations.
- be aware of the recent Good Manufacturing Practice (cGMP) inspection reports citations and FDA warning letter trends.
- be able to understand the consequences of Good Manufacturing Practice (cGMP) non-compliance.
- be able to take away the current Good Manufacturing Practice (cGMP) compliance learning from different FDA warning letters case studies.
Click here to get the “Good Manufacturing Practices (GMP): FDA Citations and Warning Letters – Lessons Learned” course.