SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations 2015

Course Description: Formal written Standard Operating Procedures (SOPs) are required both by the Food and Drug Administration (FDA) and European Medicines Agency (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 two day In-person seminar will provide step by step instructions to create SOPs for FDA-regulated organizations. Throughout the workshop, the instructor 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 instructor’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. Learning Objective: Regulatory requirements for SOPs Legal requirements for SOP creation and maintenance Types of SOPs Formats and essential components of SOPs SOP driven process: process mapping Electronic verses paper SOPs Who will Benefit: This workshop will be beneficial for the following personnel in all FDA-regulated organizations such as clinical trials, manufacturing, advertisement, marketing, regulatory affairs, auditing, and laboratory testing: Directors Managers Supervisors, and lead workers in Regulatory Affairs Quality Assurance and Quality Control personnel Auditors Clinical investigators, site management and contracting personnel Clinical