FDA Compliant SOPs for Regulated Industry — FDA Compliant SOPs for Regulated Industry: How to Create High Quality SOPs that Your Team and FDA Au

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.

​Throughout the workshop, the author will discuss case studies and examples to highlight the common errors and potential solutions. Additionally, the logistics of creating, maintaining, scope, training and documentation will be reviewed. Pros and Cons of paper and electronic SOPs will also be discussed. This workshop contains a collection of practical tips from the trainer’s extensive FDA audit experience. Common questions regarding validation requirements, handling deviations, frequency of review and update, evaluating non-SOP driven processes, global SOPs, and ways to address FDA 483s regarding SOPs will be discussed using sample SOPs. This workshop is applicable to all FDA-regulated organizations: clinical trials, manufacturing, advertisement, marketing, regulatory affairs, auditing, and laboratory testing.

Topics: FDA Regulations, FDA Compliance, SOP, Clinical Trial, Quality Management System, FDA 483 Warning, Quality Assurance, Quality Control, FDA Warning Letters