SOPs - How to Write Them to Satisfy those Inspectors

Attending this training will help the participants understand the specific requirements and expectations of FDA inspectors, allowing them to develop SOPs that meet regulatory standards and demonstrate compliance.  By learning how to write SOPs that satisfy FDA inspectors, participants can proactively identify and address potential compliance gaps or issues. This training will provide them with the knowledge and skills necessary to develop robust and comprehensive SOPs, minimizing the risk of regulatory non-compliance and associated penalties. 

Effective SOPs not only satisfy FDA inspectors but also contribute to improved operational efficiency and consistency within an organization. By attending this training, one will learn how to write SOPs that clearly outline procedures, roles, and responsibilities, promoting standardized processes and reducing variability in operations.

Well-written SOPs provide clear instructions on how to perform tasks correctly and safely. By attending this training, participants will gain insights into developing SOPs that prioritize quality and safety, aligning with the FDA's expectations. This can help mitigate risks, reduce errors, and ensure product quality and patient safety.

Attend the webinar to know why written procedures and beneficial and understand the FDA expectations for regulatory requirements and written documents.

Formal and written Standard Operating Procedures (SOPs) are the foundation of good operations. SOP deficiencies are one of the top 5 audit findings by the FDA.  Additionally, nearly every deficiency identified in FDA’s 483s, and Warning Letters can be traced back to organizations' lack of or deficient SOPs

The FDA and most other regulatory agencies require formal written procedures. Your SOPs are likely the first thing an FDA investigator will ask for when they arrive at your facility.  Did you know that SOP deficiencies are one of the top 5 findings in FDA audits? These deficiencies can compromise or cause failures in an organization’s entire Quality Management System, often leading to other FDA observations, product recalls, or even worse, Warning Letters. This training will describe common mistakes and best practices to help any organization communicate that its processes are complete, accurate, and followed consistently.

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.