When Standard Operating Procedures (SOPs) for clinical research are numerous, long, redundant, and overly detailed, they waste time and money and, worst of all, risk compliance. A simple set of “lean SOP” principles can guide SOP development and help you “shed the weight.”
This 90-minute webinar will provide you with guidelines for implementing lean principles in your company’s quality system. Starting from the position that a quality system is a powerful tool for managing risk, we’ll review the considerable risks a bloated quality system poses. We will identify the regulatory requirements for quality systems and show how the lack of specific guidance results in overbuilt quality systems. We will cover the five “lean SOP” principles and show examples of SOPs that utilize them. Finally, we’ll discuss common concerns with a lean methodology and how to overcome them.
After attending this interactive live session, you will be able to
• Identify the risks and costs associated with numerous, long, and detailed SOPs
• Develop and revise SOPs according to “lean SOP” principles
• Redesign a quality system to improve compliance and efficiency