SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations: 2-day In-person Seminar

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 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