Standard operating procedures (SOPs) are a fact of life in regulated industry. They are a critical part of almost every aspect of product production in the life sciences, and are therefore some of the most heavily scrutinized documents during regulatory audits and inspections. In fact, most FDA enforcement actions center around – or at least mention – SOPs. Often times, SOPs can actually work against you as they are too complicated, difficult to follow, or simply poorly worded. This can snowball into more issues as SOPs are changed and made more confusing. In the end, your product quality suffers and sanctions pile up.
However, by applying some simple best practices – to the structure, content, and the SOP process itself – you can begin to free yourself from “nightmare SOPs.”
During our interactive, 90-minute online course, you will learn:
- What the regulatory requirements for SOPs are – and what procedures are required by the regulations
- How to make SOPs easy to follow and use – best practices for SOP structure
- How to ensure your SOPs do what you want them to do – recommendations for SOP content authoring
- What you need to consider in your process to ensure you get the results you want – best/common industry practices