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Part 11

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Writing Procedures: Pharmaceutical and Medical Device Manufacturers

Purpose

Attendees learn to develop more meaningful, useful, and audit worthy procedures.

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

Outlines subject to modification without notice.

To speak with the lead instructor for this class please call Allan Dewes at 415.487.3500 or submit the information request form.

Contact us for a prompt reply!

Inquiry	Telephone	Email
Information via Email	(415) 487-3500	Click Here
Corporate and Consulting Services	(415) 487-3500	allan.dewes@skillsplusinc.com
Sales: Product and Services	(804) 938-4102	allan.dewes@skillsplusinc.com
Designated Representative - California Board of Pharmacy	(415) 487-3500	allan.dewes@skillsplusinc.com
Exemptee Certification - California Department of Health	(415) 487-3500	allan.dewes@skillsplusinc.com
Fax orders to	(415) 487-1926
Webmaster	(415) 487-3500	skillsplus@aol.com
Product and Service Support
On-line tech support for CBT classes		Click Here
On-line tech support for on-line purchases		Click Here
Live computer based training tech support	(415) 487-3500	Allan
Live GMP Content questions	(415) 487-3500	Allan or Jackie
Postal address	584 Castro Street #729	San Francisco, CA 94114

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