Standard Operating Procedures (SOPs) are required by law for companies that are regulated by the Code of Federal Regulations such as Title 21 and Title 42. Yet there is no guidance on how to write, organize and maintain SOPs. Consequently, SOPs are frequently written in a way that makes compliance difficult or seemingly impossible. This often leads to regulatory errors that come to light during a FDA audit. Every FDA and CLIA inspection starts with a review of SOPs. Thirty to forty percent (30%-40%) of adverse inspection issues are a result of poorly written SOPs. This course will show you how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. You will also gain a strategic view of how SOPs help streamline operations and create efficiencies, while ensuring regulatory compliance.
SOPs and their relation to the regulations
SOPs as part of the company's regulatory infrastructure
Best Practices for writing SOPs to ensure conciseness, efficiency and ease of use Risk Based approach for writing SOPs
Training on SOPs
Tools for tracking SOPs life-cycle and when validation is required
What an inspector looks for in SOPs during an inspection