Writing Effective and compliant SOPs

Why Should You Attend:

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 493. 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 downright impossible. Worse, this often leads to many regulatory errors that first come to light during an audit by an agency such as the FDA. Resolution of the audit findings then costs many hours of effort and many thousands of dollars.

This 90-minute session will show you how to write, organize, and maintain Standard Operating Procedures (SOPs) and train personnel so that you can ensure compliance in a way that is concise, reproducible and easy to follow.

Areas Covered in the Seminar:

• SOPs and their relation to the regulations.
• SOPs as part of the company's regulatory infrastructure.
• SOP on SOPs and how to ensure conciseness, consistency and ease of use.
• Risk Based approach on SOP Best Practices for creation and maintenance.
• Training on SOPs.
• Tools for SOP tracking and when is validation required.
• What the FDA looks for in SOPs during an inspection.