Description:
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 an FDA audit. Every FDA and CLIA inspection start with a review of SOPs. Thirty to forty percent (30%-40%) of adverse inspection issues are a result of poorly written SOPs.
Course Objective:
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. This FDA compliant SOPs training will explain how to write, organize, and maintain Standard Operating Procedures (SOPs) and train personnel so that you can ensure FDA compliance in a way that is concise, reproducible and easy to follow.
Course Outline:
- 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
Target Audience:
- CEOs
- Regulatory VPs / Quality VPs / IT VPs
- Regulatory Affairs Professionals
- Quality Managers
- Quality Engineers
- Small Business Owners
- GxP Personnel
- Consultants
