Managing Standard Operating Procedures (SOPs) in the FDA Regulated Environment

Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities. Currently, there is no guidance on how to develop or manage the SOP creation or the SOP quality system. Consequently, SOPs are frequently written in a way that makes compliance difficult or downright impossible. In many cases, this sometimes leads to subpar documents that come to light during a regulatory inspection.

In this 90-minute accredited training you will learn how to write, organize, and maintain SOPs and train personnel in a method that will ensure compliance in a way that is reproducible and easy to follow.

This training will cover such topics as:

- Why written procedures are beneficial

- FDA expectations for written documents and Regulatory Requirements

- Developing an effective review and approval process compliant with regulatory requirements

- How to implement a training program for document creation and review

- A system for the control, archival, and disposal of written procedures.

THIS TRAINING IS PART OF OUR GMP LABORATORY CONTROL PROFESSIONAL CERTIFICATION

• To enroll into the complete GMP Laboratory Control Certification Program CLICK HERE.  This program includes 10 specific online courses for $2050.
• To learn more about our certification programs, visit our website at Certifications 

​To register for this individual course ONLY, click the Register Now button below.