Writing SOPs for cGMP Compliance

Those who are responsible for, or may be involved in, writing or revising “Standard Operating Procedures” for bulk or finished pharmaceuticals.
Suppliers of drug components including raw materials, containers, closures, and other packaging materials.

You should possess a working knowledge of Current Good Manufacturing Practice (cGMP) regulations or have had prior cGMP training before attending this course.

Description:
This two-day practical course is designed to detail a step-bystep outline for writing “Standard Operating Procedures” and to adapt this outline for use in many specific applications.

Although the FDA’s Current Good Manufacturing Practice regulations state requirements for “Standard Operating Procedures,” this is the one area most likely to be cited by the FDA upon an inspection. During this course, you will acquire a better understanding of what the FDA is looking for. Methods used for compiling information, assignment of responsibility for departmental procedures, control of procedures and documentation, and instruction on technical writing will also be discussed.

Open workshops will offer direct solutions for your particular problems, as well as demonstrating the process of writing procedures for so called “gray areas.” The workshops are designed to allow you to construct a written procedure for a hypothetical manufacturing situation.

This course is particularly helpful to those involved with manufacturing in the pharmaceutical and vitamin industry. Emphasis will be placed on new plant start-up, plant revision, companies experiencing rapid growth or expansion, and how to improve regulatory compliance through procedures.