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FDA Compliant SOPs for Regulated Industry — FDA Compliant SOPs for Regulated Industry: Documents of Ideal Quality Management Systems
25 Sep 2025 - 26 Sep 2025 • washington dc, United States
Organizer:
FDAMap
Abstract:
SOP deficiencies are one of the top 5 findings in FDA audits. The entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects. Formal written Standard Operating Procedures (SOPs) are required both by the FDA and EMA. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This workshop will provide step by step instructions to create SOPs for FDA-regulated organizations.
Topics:
SOP, Quality Management System, Regulatory Affairs, FDA Regulation, FDA Compliance
Event listing ID:
1673555


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Last updated: 26 August 2025