SOPs - How to Write Them to Satisfy those Inspectors

Your standard operating procedures are likely the first thing an FDA investigator asks for. This 60-minute SOP writing webinar explains what inspectors expect and how to write SOPs that meet regulatory requirements and show compliance.

You'll learn to write procedures that clearly set out steps, roles and responsibilities, so processes are standardized and variation is reduced. Writing with inspectors in mind also helps you spot and fix compliance gaps before an inspection does.

Well-written SOPs give clear instructions for doing tasks correctly and safely, which supports product quality, patient safety and day-to-day efficiency. The session covers common mistakes and best practices for showing that your processes are complete, accurate and followed consistently.

• Explain why written procedures are beneficial
• Describe FDA expectations for written procedures and documents
• Write SOPs that clearly define steps, roles and responsibilities
• Identify and close compliance gaps in existing SOPs
• Avoid common SOP mistakes

• Why written procedures are the foundation of good operations
• FDA expectations for written procedures and documents
• How SOP deficiencies lead to 483s, Warning Letters and recalls
• Writing SOPs that define procedures, roles and responsibilities
• Building quality and safety into SOPs
• Common SOP mistakes
• Best practices for complete, accurate and consistently followed procedures

FDA and most other regulators require formal written procedures, and SOP deficiencies are among FDA's top five audit findings. Almost every deficiency in 483s and Warning Letters can be traced to missing or weak SOPs, and those gaps can undermine an entire quality management system.

The session suits regulatory, QA, QC and quality systems staff, document control, CAPA, compliance and training specialists, internal auditors, supplier quality engineers, process owners and technical writers who create, review or approve SOPs.

The following professionals will benefit from this training: 

• Managers
• Supervisors, and lead workers in Regulatory Affairs
• Quality Assurance and Quality Control personnel
• Quality systems specialists
• Document control specialists
• CAPA specialists and managers
• Regulatory and compliance specialists
• Internal auditors and managers
• Training specialists and managers
• Subject matter experts and process owners who write procedures
• CAPA Specialists
• Supplier Quality Engineers and Auditors
• Directors, Managers
• Technical writers and General staff with the responsibility for creating, reviewing, and approving written standard operating procedures and instructions

Meredith Crabtree has over 25 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical devices, Cosmetics, Supplements, and Animal Health manufacturing and distribution. Meredith works as a Quality Consultant performing label reviews, 3rd party inspections, Consent Decree, and Recall support. She also performs regulatory assessments and Quality training. Meredith has a degree in Medical Technology and is currently obtaining a degree in Quality Systems.