SOP  Writing  Workshop

This program is typically a two day workshop targeted at individuals in your company who are responsible for writing SOP’s. Generic SOP’s are used in the training one day one as examples. On Day two participants develop new internal SOP’s and evaluate the effectiveness of your current procedures.

¨     Examine the FDA requirements and ISO perspective on procedures

¨     Learn the Pre-requisites for SOP design and development

¨     Discussion of the Key Elements of a good procedure

¨     Get involved in an exercise on Process Flow Diagramming as a means of creating an outline of the key process content required for well written procedures

¨     Learn SOP preparation and validation techniques

¨     Discuss the SOP approval process and controlling the distribution of your SOP’s

¨     Focus on Change Control System for SOP’s

¨     Examine procedural training techniques

¨     Review some of your current procedures for completeness and effectiveness using a GMP Learning SOP Assessment Guide

¨     Develop some SOP’s that your company currently needs to have,  including a Master SOP