How to Write Perfect FDA-Compliant SOPs: Stepwise Instructions
Deficiency in Standard Operating Procedure (SOPs) is one of the top 5 findings at FDA audits at most FDA-regulated organizations. Written SOPs are keystone of quality management systems (QMS) and compliant operations. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This seminar, given by an industry-leading expert who has written and reviewed thousands of SOPs at hundreds of FDA-regulated organizations, will provide step by step instructions to create and implement SOPs. The author will use case studies and examples to highlight common errors and potential solutions. Additionally, the logistics of creating, maintaining, scope, training and documentation will be reviewed. Pros and Cons of paper and electronic SOPs will also be discussed. This seminar contains a collection of practical tips from the trainer’s extensive FDA audit experience. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. Let that not be your organization.
Areas Covered in the Session:
Why should you attend:
This seminar will help you evaluate your current SOPs for the presence of most common issues identified by FDA during audits. You will get practical tips and tested strategies for creating, revising, updating, training, and documenting SOP processes at your organization. The case studies will highlight the key concepts, alternate methods, and least-burdensome approach to compliance with FDA regulations.
Who will benefit:
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