Procedure Writing
Home Up Essentials for Pharmaceuticals Root Cause Procedure Writing Executive Session GMP/QSR Trainer Certification Evaluations

 

We also recommend: [Auditing: Internal and External Customers and Supplies] [Faster Product Release Through Efficient Batch Record Review]

 

Procedure Writing for Greater Process Control

Purpose

To develop more useful procedures that truly guide performance.

Objectives

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

Course Topics

 

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

Other supporting documents

Activity: Writing clinic

 

Approval and Change Control

Review and approval responsibility

Review frequency

Tracking procedures through the change process

 

Procedures and Training

Using the procedure for training

How to conduct training

From the procedure to performance coaching

 

Summary

 

Call to learn about how we can customize this outline for any of your site's CGMP training needs. Standard outlines may change without notice. To speak with the lead instructor for this class please call Allan Dewes at 415.948.5220.

 

For a prompt reply to requests and questions:  415.948.5220 |  skillsplus@aol.com    |   Fax: 954.566.5225

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