Writing SOPs for cGMP Compliance
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This course is available as a client site course. Please click here for more information.
Who Should Attend
This basic course is designed for professionals involved with
manufacturing in the pharmaceutical and dietary supplements
industries. It has been most beneficial to:-
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.