Purpose

To develop more useful procedures that truly guide performance.

1. State the role of procedures.

2. Conduct a task analysis and knowledge assessment.

3. Determine appropriate procedure content.

4. Evaluate consistency and functionality of procedure format.

5. Write SOP statements and instructions.

6. Identify the procedures intended target audience.

7. State the regulatory guidelines for writing procedures.

8. Describe the procedure change control process.

9. Use procedures for training.

About the Class

Introduction

CGMP Requirements

The role of procedures

How the FDA and our company use procedures

CGMP procedure related observations

Task Analysis

Using flow charts

Incorporating skills and knowledge in procedures

Decision making as a process in procedures

Tools and aids to job performance

Sources of procedure information

Step and task sequencing in procedures

Activity: Writing clinic

Procedure Format

Sections of procedures

Company-specific formats and sections

Using each section

Activity: Writing clinic

Human Factors

Cognitive capacity

Structuring the procedure

Assuring greater retention

Identifying the target audience

Literacy and the procedures

Tricks to make procedures more readable

FDA perspective on procedure readability and comprehension

Activity: Writing clinic

Writing the Procedure

Action words for simplicity

Specific versus general statements

Ranges versus discrete values

Attachments